Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:James Dakota GreenCEOVacation Inc.936 SW 1st Ave #888Miami,FL33130United Statesvacation@vacation.incIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 6, 2025RE: 706039Dear Mr. Green:This letter is to advise you that on March 5th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://www.vacation.inc/, where your “Vacation® Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE” and “Vacation® Classic WHIP GLOW BROAD SPECTRUM SPF 30 SHIMMER SUNSCREEN MOUSSE” drug products (hereinafter collectively referred to as “Classic Whip Sunscreens”) are available for purchase in the United States without a prescription. We also reviewed your social media on Instagram at “vacationinc” which directs consumers to your website to purchase your products.Your “Classic Whip Sunscreens” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the “Classic Whip Sunscreens” product labeling, including your website and social media page listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“Vacation® Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE” and “Vacation® Classic WHIP GLOW BROAD SPECTRUM SPF 30 SHIMMER SUNSCREEN MOUSSE”“Uses∙ Helps prevent sunburn ∙ If used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun.” [from your product labels]“BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE” [from your product labels]“Vacation® Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE”“Classic Whip SPF 30 ‘Dessert For Your Skin’ SPF 30 Sunscreen Mousse…What it is‘lighter-than-air’ sunscreen featuring an authentic ‘tilt valve’ actuator that produces perfect, star-shaped mountains of foam, inspired by everyone’s favorite after dinner indulgence.” [from your product website]“…a decadent dessert for the skin that we like to call Vacation® Classic Whip. A Broad-Spectrum SPF 30 Sunscreen Mousse…But don’t be fooled by its appearance, because just like the rest of the Vacation® Brand Family of Products, this SPF gives your skin everything it needs to stay protected during long days by the pool...” [from your Instagram social media page]“Vacation® Classic WHIP GLOW BROAD SPECTRUM SPF 30 SHIMMER SUNSCREEN MOUSSE”“Classic Whip Glow SPF 30 ‘Classic Whip, Now With Shimmer’ SPF 30 Shimmer Sunscreen Mousse…What it islightweight, ‘dessert-inspired’ sunscreen you know and love…” [from your product website]“…With the new Vacation® Brand Classic Whip Glow, treat your skin to fluffy, glistening dollops of sunscreen mousse all at the gentle press of its authentic ‘tilt valve’…” [from your Instagram social media page]Based on the above labeling, your “Classic Whip Sunscreens” are intended for use as over-the-counter (OTC) sunscreen drug products. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your drug products. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your products. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of a sunscreen in foam (aka, mousse or whip) dosage form.3As previously stated, there are no FDA-approved applications in effect for your drug products.Thus, even if your products were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not new drugs under section 505G(a)(1), they do not comply with the requirements under section 505G. Accordingly, your “Classic Whip Sunscreens” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).Furthermore, your “Classic Whip Sunscreens” are misbranded under Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), which provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading,” because they are packaged in containers that resemble food canisters customarily purchased by U.S. consumers. Specifically, your sunscreens are presented in metal canisters with a “authentic ‘tilt valve’ actuator” that outputs a star-shaped foam and have a strong overall resemblance to the metal canisters ordinarily used to package whipped cream products and similar dessert toppings.4Packaging drug products in containers that resemble food containers commonly used by adults and children can mislead consumers into mistaking the products for food, which is of particular concern as this increases the risk of accidental ingestion.The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name and the unique identifier “706039” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration______________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6204 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6204 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam, mousse, or whip dosage form.3Your labeling appears to use these three terms interchangeably to describe your product: the principal display panel, as well as other labeling, refers to each product as “mousse” and “whip”, while other labeling cited above describes each product as a foam. “Foam” is the dosage form term in United States Pharmacopeia (USP) general chapter , Pharmaceutical Dosage Forms, that best corresponds to your product; neither “whip” nor “mousse” are used in that reference.4Your website and social media, including those cited above emphasize the visible similarity between the container for your sunscreens and whipped cream containers. For example, your website states “What it is‘lighter-than-air’ sunscreen featuring an authentic ‘tilt valve’ actuator that produces perfect, star-shaped mountains of foam, inspired by everyone’s favorite after dinner indulgence.” You worked with the original developer of Reddi-wip® to develop your containers. See ClaytonCorp.com (last visited March 7, 2025) (indicating both that “Clayton Corp. created the first aerosol food product with the invention of Reddi-Wip®” and that the “Clayton Corporation recently partnered with the sunscreen brand Vacation® to develop an aerosol solution for their air whipped formula” with a photograph of your Classic Whip SPF 30 Sunscreen container.)

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Anna XavierCEOKalani AB dba Kalani SunwearBrahegatan 28114 37StockholmSwedeninfo@kalani.seIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 6, 2025RE: 710998Dear Ms. Xavier:This letter is to advise you that on May 7th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://kalanisunwear.com/, where your “Kalani sunwear SUN MOUSSE SPF 50” drug product is available for purchase in the United States without a prescription. We also reviewed your social media pages on Instagram at “kalanisunwear,” which directs consumers to your website to purchase your product, and your Facebook at “Kalani.”Your “Kalani sunwear SUN MOUSSE SPF 50” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples from the “Kalani sunwear SUN MOUSSE SPF 50” product labeling, including your website and social media pages listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:“SUNSCREEN MOUSSE SPF 50… Sunscreen SPF 50… WARNINGS:… Reducing the quantity of sunscreen product applied will lower the level of protection significantly” [from the label of your product on your product website]“Introducing our Kalani sunwear Sun Mousse SPF 50: your ultimate defence against the sun’s rays!” [from your product website]“High Sun Protection (SPF 50). Experience top-tier protection against harmful UV rays, ensuring your skin stays safeguarded in the sunniest conditions…Wide Spectrum Protection. Guard your skin against UVA and UVB rays with our broad-spectrum formula, leaving no room for compromise.” [from your product website]“Say goodbye to sunburns and hello to radiant, protected skin! Discover the ultimate sun mousse that feels as light as a cloud while giving you SPF 50 protection…” [from your Instagram social media page]Based on the above labeling, your “Kalani sunwear SUN MOUSSE SPF 50” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam (aka mousse) dosage form,3. As previously stated, there is no FDA-approved application in effect for your drug product.Thus, even if your product was in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “Kalani sunwear SUN MOUSSE SPF 50” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Additionally, the formulation for your “Kalani sunwear SUN MOUSSE SPF 50” does not comply with the conditions specified under M020. Specifically, to conform to the conditions of the monograph, your product must contain at least one of the active ingredients listed in § M020.10. Certain combinations of active ingredients are also permitted, as set out in § M020.20(a). We note that your “Kalani sunwear SUN MOUSSE SPF 50” label does not identify any of the ingredients as active ingredients; however, of your product’s labeled ingredients: “Aqua, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dibutyl Adipate, Phenethyl benzoate, C12-15 Alkyl Benzoate, Butane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Propane, Ethylhexyl Triazone, Palmitic Acid, lsobutane, Stearic Acid, Silica, Phenoxyethyl Caprylate, Cetearyl Alcohol, Tocopheryl Acetate, Sorbitan Laurate, Polyglyceryl-4 Laurate/ Succinate, Triethanolamine, Tetrasodium Glutamate Diacetate” none are permitted active ingredients under M020 when used in combination or as sole ingredients.Therefore, as formulated and labeled, “Kalani sunwear SUN MOUSSE SPF 50” does not comply with the applicable conditions specified in M020 and has not otherwise been found GRASE. Accordingly, “Kalani sunwear SUN MOUSSE SPF 50” is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p) and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no application in effect for this product, this product is an unapproved new drug. Introduction or delivery for introduction of such products into interstate commerce violates section 301(d) of the FD&C Act, 21 U.S.C. 331(d).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name and the unique identifier “710998” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_____________________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6204 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6204 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam (aka) mousse dosage form.3The principal display panel of your product label, as well as other labeling, uses the term “mousse” to describe your product. “Foam” is the dosage form term in United States Pharmacopeia (USP) general chapter , Pharmaceutical Dosage Forms, that best corresponds to your product; “mousse” is not used in that reference.

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Shirly Gutshtat, CEOKeren Elisar, Founder & PresidentK & Care OrganicsSimtat Hadayagim 2 StMikhmoret4029700Israelinfo@kcare.co.ilIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 6, 2025RE: 711000Dear Ms. Gutshtat and Ms. Elisar:This letter is to advise you that on May 14th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website https://www.botaobaby.com/, for your “BOTAÓ GROW NATURALLY Kids Mineral Foam Spray” (hereinafter “BOTAÓ Kids Mineral Foam Spray”), “BOTAÓ GROW NATURALLY Baby Mineral Foam Spray” (hereinafter “BOTAÓ Baby Mineral Foam Spray”), and “SUN & SHINE SPF 50+ BROAD SPECTRUM Mineral Sunscreen Mousse,” (hereinafter “SUN & SHINE Sunscreen Mousse”) sunscreen drug products, which are available for purchase in the United States without a prescription.Your “BOTAÓ Kids Mineral Foam Spray,” “BOTAÓ Baby Mineral Foam Spray,” and “SUN & SHINE Sunscreen Mousse” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the products’ labeling, including the most recent labeling submitted to FDA as part of drug listing pursuant to 21 CFR part 207, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“BOTAÓ Kids Mineral Foam Spray”“Uses∙ helps prevent sunburn…” [from your product label]“BOTAO Mineral Sunscreen Foam Spray SPF 50+ for Kids, blends Zinc Oxide, a natural mineral filter for broad spectrum protection…” [from your product label]“Contains Zinc Oxide, 100% natural mineral filter known to be safe for use on kids. Providing high protection from harmful UVA and UVB rays, BOTAO sunscreen Foam is gentle on the skin and easily absorbed…” [from your product website]“BOTAÓ Baby Mineral Foam Spray”“Uses∙ helps prevent sunburn…” [from your product label]“BOTAO Mineral Sunscreen Foam for Babies Broad Spectrum SPF 50+, contains Zinc Oxide, a natural mineral filter known to be safe for use on babies…” [from your product label]“Contains Zinc Oxide, 100% natural mineral filter known to be safe for use on babies. Providing high protection from harmful UVA and UVB rays, BOTAO sunscreen is gentle on the skin and easily absorbed.” [from your product website]“SUN & SHINE Sunscreen Mousse”“Uses∙ helps prevent sunburn…” [from your product label]“Mineral Sunscreen Mousse Broad Spectrum SPF50+ Sunscreen For Face and Body” [from your product label]Based on the above labeling, your “BOTAÓ Kids Mineral Foam Spray,” “BOTAÓ Baby Mineral Foam Spray,” and “SUN & SHINE Sunscreen Mousse” are intended for use as over-the-counter (OTC) sunscreen drug products. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your drug products. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your products. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing sunscreen in a foam (aka mousse) dosage form3. As previously stated, there are no FDA-approved applications in effect for your drug products.Thus, even if your products were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not new drugs under section 505G(a)(1), they do not comply with the requirements under section 505G. Accordingly, “BOTAÓ Kids Mineral Foam Spray,” “BOTAÓ Baby Mineral Foam Spray,” and “SUN & SHINE Sunscreen Mousse” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name and the unique identifier “711000” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_______________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6204 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6204 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam (aka mousse) dosage form.3The principal display panels of your product labels, as well as other materials, use the terms “foam spray,” “foam,” and/or “mousse” to describe each of your products that are the subject of this letter. “Foam” is the dosage form term in United States Pharmacopeia (USP) general chapter , Pharmaceutical Dosage Forms, that best corresponds to your products; “mousse” is not used in that reference. Additionally, USP defines “foam” and “spray” as two distinct dosage forms. Images, video, and text regarding your products confirm that each of the products addressed in this letter meets USP’s definition of “foam”—i.e., each appears as a dispersion of gas in a liquid or solid continuous phase wherein the liquid or solid contains the drug substance and suitable excipients.

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Dr. Harry FallickFounder & CEOFallien Cosmeceuticals Ltd. dba Fallene Ltd.2541 General Armistead AveNorristown,PA19403United Statesinfo@tizoskin.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 6, 2025RE: 711006Dear Dr. Fallick:This letter is to advise you that on May 14th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://tizoskin.com/, where your “TiZO® SHEERFOAM™ Non-Tinted SPF 30 MINERAL SUNSCREEN FOR BODY & FACE” (hereinafter “TiZO® SHEERFOAM™ SPF 30”) drug product is available for purchase in the United States without a prescription. We also reviewed your social media pages on Instagram at “tizoskin” and Facebook at “Tizo Skin” which directs consumers to your website to purchase your product.Your “TiZO® SHEERFOAM™ SPF 30” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the bodyExamples from the “TiZO® SHEERFOAM™ SPF 30” product labeling, including the most recent labeling submitted to FDA as part of drug listing pursuant to 21 CFR part 207 and your website and social media pages listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:“UsesHelps prevent sunburn” [from your product label]“TIZO® SheerFoam™ is a patented, mineral sunscreen mousse. This unique formulation offers sheer, weightless protection while providing superb photo-protective performance. This light, foaming sunscreen dries virtually invisible on any complexion.” [from your product website]“Physical broad spectrum protection…” [from your product website]Based on the above labeling, your “TiZO® SHEERFOAM™ SPF 30” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1 However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2 To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of a sunscreen in foam (aka mousse) dosage form.3 As previously stated, there is no FDA-approved application in effect for your drug product.Thus, even if your product was in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “TiZO® SHEERFOAM™ SPF 30” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name and the unique identifier “711006” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6204 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6204 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam or mousse dosage form.3Your labeling appears to use these two terms interchangeably to describe your product: the principal display panel, as well as other labeling, appears refers to the product as a “foam” and “mousse.” “Foam” is the dosage form term in United States Pharmacopeia (USP) general chapter , Pharmaceutical Dosage Forms, that best corresponds to your product; “mousse” is not used in that reference.

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Lisa SequinoCEOSupergoop!200 East Grayson Suite #110San Antonio,TX78215United Stateshello@supergoop.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 6, 2025RE: 711018Dear Ms. Sequino:This letter is to advise you that on May 2nd, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, http://supergoop.com/, where your “Supergoop! PLAY SPF 50 BODY MOUSSE” drug product is available for purchase in the United States without a prescription. We also reviewed your social media pages on Instagram at “supergoop” and Facebook at “Supergoop” which directs consumers to your website to purchase your product.Your “Supergoop! PLAY SPF 50 BODY MOUSSE” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples from the “Supergoop! PLAY SPF 50 BODY MOUSSE” product labeling, including the most recent labeling submitted to FDA as part of drug listing pursuant to 21 CFR part 207 and your website and social media pages listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:“Broad Spectrum Sunscreen SPF 50” [from your product label]“Helps prevent sunburn…” [from your product label]“A lightweight, whipped sunscreen mousse that’s water- & sweat-resistant...” [from your product website]“This innovative SPF was created to be the perfect family-friendly sunscreen…a fun mousse texture…” [from your product website]“Sunscreen innovation at its finest: lightweight, whipped, antioxidant-rich sunscreen mousse with SPF 50 protection…” [from your Instagram social media page]Based on the above labeling, your “Supergoop! PLAY SPF 50 BODY MOUSSE” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of a sunscreen in foam (aka, mousse or whip) dosage form.3As previously stated, there is no FDA-approved application in effect for your drug product.Thus, even if your product was in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “Supergoop! PLAY SPF 50 BODY MOUSSE” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name and the unique identifier “711018” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration______________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6204 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6204 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a mousse dosage form.3Your principal display panel, as well as other labeling, appears to use the terms “mousse” and “whipped” to describe your product. “Foam” is the dosage form term in United States Pharmacopeia (USP) general chapter

Delivery Method:VIA UPSReference #:320-25-90Product:DrugsRecipient:Mr. Neal FlowersPresidentGussyup LLC dba Private Label Grooming7360 Eastgate Rd, Suite 135Henderson,NV89011-4091United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-90July 9, 2025Dear Mr. Flowers:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Gussyup LLC (dba Private Label Grooming), FEI 3029236854, at 7360 Eastgate Rd, Suite 135, Henderson, from February 18 to 20, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483. At the end of the inspection, your firm notified the Agency that you do not intend to manufacture OTC drug products and have discontinued your FDA drug registration.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:Adequate testing of your finished drug products, prior to release and distribution (21 CFR 211.165 (a) and (b)).Establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).Adequate batch production and control records that include complete documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive, independent assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).o All procedures that describe these and other elements of your remediated stability program.A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.Your master production and control records for your drug products, to demonstrate that they fully document each significant and validated manufacturing step.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You manufacture over-the-counter (OTC) drug products. Your firm failed to test incoming components used in manufacturing your finished OTC drug products to determine identity, purity, strength, and quality. Additionally, your firm did not establish a vendor qualification program for your raw material suppliers.Your firm used results from your suppliers’ certificates of analysis (COAs) without establishing the reliability of your suppliers’ analyses through appropriate validation and without conducting at least one specific identity test on each incoming lot of components. You can not rely on your suppliers’ COA to verify the identity of your components.The use of ingredients contaminated with diethylene glycol (DEG) or ethylene glycol (EG) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.In response to this letter, provide:A comprehensive independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the components you use to manufacture drug products.A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPAs that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.Drug Production CeasedWe acknowledge your commitment to cease production of all OTC drugs at this facility. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to continue manufacturing and shipping drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3029236854 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

近日，省药品监管局派出检查组赴甘肃省对我省一药品生产企业使用的中药材开展了GAP延伸检查。经综合评定，该企业及其合作基地符合GAP要求，成为贵州省首家通过此项检查的企业。GAP作为中药材从种植到加工、储运全过程的质量管理规范，是保障中药材质量安全、促进中药产业健康发展的重要技术标准。此次检查的顺利通过，标志着我省中药材质量监管工作取得新突破。本次GAP延伸检查严格依据《国家药监局综合司关于印发〈中药材生产质量管理规范〉监督实施示范建设方案的通知》（药监综药管〔2023〕313号）要求开展。检查组对位于甘肃省定西市陇西县的黄芪种植基地进行了全面检查，重点核查了种植环境、种质资源、田间管理、采收加工、包装储运等关键环节的质量管控情况。省药品监管局将以此次检查为契机，一是积极扩大GAP实施范围，推动更多企业参与规范化种植，保障药品生产源头安全可靠；二是积极引导企业加强源头管理，提升内在质量，塑造贵州中药高质量品牌；三是继续强化与有关部门协作，构建更高效的中药材生产质量监管机制，助力我省中药产业高质量发展，为人民群众提供优质中药服务。

按照《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械临床试验机构监督检查办法（试行）》及《云南省药品监督管理局涉企行政检查管理办法（试行）》等有关规定，云南省药品监督管理局对医疗器械生产企业和临床试验机构开展监督检查，现将检查结果（第1期）通告如下。附件：1.2025年云南省医疗器械生产企业监督检查结果（第1期）2.2025年云南省医疗器械临床试验机构监督检查结果（第1期） 云南省药品监督管理局 2025年8月11日2025年云南省医疗器械生产企业监督检查结果（第1期）序号被检查单位检查目的检查类型检查结论1云南欧铂斯医疗科技有限公司合规日常监督检查限期整改2昆明琪美雅义齿制作有限公司合规日常监督检查限期整改3昆明思安生物科技有限公司合规日常监督检查限期整改4云南可静生物科技有限公司合规日常监督检查限期整改5灵力（云南）医疗科技有限公司合规日常监督检查限期整改6红云制药（昆明）有限公司合规日常监督检查限期整改7云南众乾义齿科技有限公司合规日常监督检查限期整改8昆明三稻医疗设备有限公司合规日常监督检查限期整改9云南好迪医疗器械有限公司合规日常监督检查限期整改10云南运圣医疗器械有限公司合规日常监督检查限期整改11昆明博皓义齿制作有限公司合规日常监督检查限期整改12文山圣兰义齿制作有限公司合规日常监督检查限期整改13云南海福盈医疗器械有限公司合规日常监督检查限期整改14昆明佳英义齿制作有限公司合规日常监督检查限期整改15玉溪市惟佳口腔义齿制作中心合规日常监督检查限期整改16云南贝泰妮生物科技集团股份有限公司合规日常监督检查限期整改17云南贝泰妮健康科技有限公司合规日常监督检查限期整改18昆明南梓晨医疗器械有限公司合规日常监督检查限期整改19云南德华生物药业有限公司合规日常监督检查限期整改20科凝美（昆明）生物科技有限公司合规日常监督检查限期整改21昆明同心医联科技有限公司合规日常监督检查限期整改22云南中齿医疗科技有限公司合规日常监督检查限期整改23云南象山医用材料有限公司合规日常监督检查限期整改24昆明腾骥医疗器械工贸有限公司合规日常监督检查限期整改25云南颌顺医疗器械有限公司合规日常监督检查限期整改26超维口腔医疗（云南）有限公司合规日常监督检查限期整改27昆明吉圣祥医疗器械有限公司合规日常监督检查限期整改28云南省普洱市金利湾生物科技有限公司合规日常监督检查限期整改29昆明康业医疗器械有限公司合规日常监督检查限期整改30临沧旭正医药用品制造有限公司合规日常监督检查限期整改31云南众益鑫科技有限公司合规日常监督检查限期整改32大理云皓义齿制作有限公司合规日常监督检查限期整改33云南睿影医疗科技有限公司合规日常监督检查限期整改34云南明峰医疗科技有限公司合规日常监督检查限期整改35创邦医疗健康科技（云南）有限公司合规日常监督检查限期整改36壹邦医疗健康科技（云南）有限公司合规日常监督检查限期整改37云南晨业生物科技有限公司合规日常监督检查限期整改38云南力衡医疗技术有限公司合规日常监督检查限期整改39云镶医疗器械（云南）有限公司合规日常监督检查限期整改40云南白药集团医药电子商务有限公司合规日常监督检查限期整改41昆明德臣华兴义齿制作有限公司合规日常监督检查限期整改42云南昊戌生物科技有限公司合规日常监督检查限期整改2025年云南省医疗器械临床试验机构监督检查结果（第1期）序号被检查单位检查目的检查类型检查结论1昭通市中医医院合规临床机构检查限期整改2祥云县人民医院合规临床机构检查限期整改3蒙自市人民医院合规临床机构检查限期整改4昆明市延安医院合规临床机构检查限期整改5云南省肿瘤医院合规临床机构检查限期整改6禄丰市人民医院合规临床机构检查限期整改7昆明医科大学第一附属医院合规临床机构检查限期整改8云南省第一人民医院合规临床机构检查限期整改9云南大学附属医院合规临床机构检查限期整改

行政处罚案件信息摘要行政处罚决定书文号湘药监械罚〔2025〕26号当事人长沙心诺医疗器械有限公司组织机构代码91430181MA4QT70Q8H法定代表人肖永初违法类型生产说明书、标签不符合规定的医疗器械案行政处罚内容处1万元罚款作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年8月12日备注

为加强药品质量监管，保障公众用药安全，根据广东省药品抽检计划,广东省药品监督管理局组织对全省药品生产、经营、使用环节进行药品质量抽查检验，现将药品质量抽查检验结果予以通告（见附件1）。　　对抽查检验不符合规定药品，药品监督管理部门已要求相关企业和单位采取暂停销售使用、召回等风险控制措施，对不符合规定原因开展调查并切实进行整改。　　广东省药品监督管理局要求相关地市药品监督管理部门依据《中华人民共和国药品管理法》，组织对相关企业和单位存在的涉嫌违法行为立案调查，并按规定公开查处结果。　　附件：1.药品质量抽查检验结果（2025年第6期）　　2.相关概念和名词解释广东省药品监督管理局2025年8月11日附件2相关概念和名词解释不符合规定药品有关项目解析：pH值：是衡量溶液酸碱性强弱程度的数值，用于表示溶液中氢离子（H⁺）浓度的大小。含量测定：指用化学、仪器或生物测定的方法，对原料及制剂中有效成分的含量进行测定。水分：是指药品中含有水的含量。性状：记载药品的外观、质地、断面、臭、味、溶解度、以及物理常数等。浸出物：系指用水或其他适宜的溶剂对药材和饮片中可溶性物质进行的测定。总灰分：总灰分是把一定量的样品经炭化后放入高温炉内灼烧，使有机物质被氧化分解，以二氧化碳、氮的氧化物及水等形式逸出，而无机物质以硫酸盐、磷酸盐、碳酸盐、氯化物等无机盐和金属氧化物的形式残留下来，这些残留物即为灰分。称量残留物的重量和样品重量，两者的比值即为样品中总灰分的含量。