FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs). FDA investigations find the APIs include: � anticoagulants (e.g., Warfarin) � anticonvulsants (e.g., Phenytoin) � HMG-CoA reductase inhibitors (e.g., Lovastatin), � Phosphodiesterase type 5 inhibitors (e.g., Sildenafil) � prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., Indomethacin) � beta-blockers (e.g., Propranolol) � controlled substances (Benzodiazepines and anabolic steroids) � APIs removed from the market for reasons of safety or efficacy (e.g., Sibutramine) � novel synthetic steroids, and new chemicals ingredients of unknown safety and efficacy. These APIs, because of their toxicity or other potential for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer such products. FDA analyses and investigations revealed that these products frequently contain the same APIs, or analogues of APIs, that are in FDA-approved drugs. Depending on the circumstances, these products are misbranded and unapproved new drugs, or adulterated food under the Federal Food, Drug, and Cosmetic Act. Note: Charge statement revised on 04/23/2019.
PRODUCTS: Dietary Supplements Unapproved New Drugs Misbranded Drugs PRODUCT CODE: "See Red List" PROBLEM: Unapproved New Drugs; Misbranded Drugs, Unapproved Food Additive; Adulterated Food
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA) [Unapproved new drug, Section 505(a)]" OASIS Charge Code: UNAPPROVED "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) that lacks adequate directions for use. [Misbranded, Section 502(f)(1)]" OASIS Charge Code: DIRECTIONS "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]" Contains: OASIS Charge Code: POISONOUS "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated because it appears to bear or contain a food additive that is unsafe within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)]" OASIS Charge Code: UNSAFE ADD
Districts may detain without physical examination the specified products from the firms listed in the Red List of this import alert. Districts should submit a recommendation for addition to the Red List when detained products appear to meet the criteria in this alert, and are not listed on the Red list of this import alert. DIO and FDA's Center for Drug Evaluation and Research (CDER) or FDA's Center for Food Safety and Applied Nutrition (CFSAN) will evaluate regulatory recommendations on a case-by-case basis. For any product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement that is not covered by an approved new drug application (NDA), an approved abbreviated new drug application (ANDA), or other limited exemptions under the Federal Food, Drug, and Cosmetic Act (and applicable regulations) from the requirement for an approved application, and contains an API, or an analogue of an API described above, misbranded drug and unapproved new drug, or adulterated food charges may be appropriate based on the criteria described below. Unapproved new drug and misbranded drug For any product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, whose labeling indicates that the product appears to be intended for use as a drug, under Section 201(g)(1)(B), the unapproved new drug [Section 505(a)] and misbranded drug [Section 502(f)(1) & (f)(2)] charges are appropriate. For a product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, that is excluded from the definition of a dietary supplement under Section 201(ff)(3)(B) and whose labeling indicates that the product appears to be intended for use as a drug, under Section 201(g)(1)(C), the unapproved new drug [Section 505(a)] and misbranded drug [Section 502(f)(1) & (f)(2)] charges are appropriate. Adulterated food For a product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, but whose labeling does not indicate that the product appears to be intended for use as a drug, the adulterated food [Section 402(a)(2)(c)] charge is appropriate because the APIs of the type identified above are unsafe food additives within the meaning of section 409 of the Act. A food product to which such an API is added is considered to be adulterated as defined in section 402(a)(2)(c) of the Act. The APIs of the type identified above also represent a poisonous or deleterious substance in food; therefore the adulterated food [Section 402(a)(1)] charge is also appropriate. INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST: In order to be removed from the red list, the firm should submit evidence to FDA establishing that the conditions that gave rise to the appearance of the violation have been resolved, so that the agency will have confidence that future entries will be in compliance with the Act. For additional guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, Section 9-6, "Detention Without Physical Examination (DWPE)." All requests for removal from detention without physical examination may be sent via email to: importalerts2@fda.hhs.gov Or mailed to: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Requests for removal from detention without physical examination will be reviewed by DIO and referred to CDER Imports Exports Compliance Branch or CFSAN Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Branch for additional evaluation. The Center will review analytical data, labels, and labeling submitted in support of removal of products from detention without physical examination. For questions or issues involving import operations, contact DIO's Import Operations and Maintenance Branch at (301) 796-0356. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at FDAPRIVATELABIMPORTALERTS@fda.hhs.gov
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs). FDA investigations find the APIs include: � anticoagulants (e.g., Warfarin) � anticonvulsants (e.g., Phenytoin) � HMG-CoA reductase inhibitors (e.g., Lovastatin), � Phosphodiesterase type 5 inhibitors (e.g., Sildenafil) � prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., Indomethacin) � beta-blockers (e.g., Propranolol) � controlled substances (Benzodiazepines and anabolic steroids) � APIs removed from the market for reasons of safety or efficacy (e.g., Sibutramine) � novel synthetic steroids, and new chemicals ingredients of unknown safety and efficacy. These APIs, because of their toxicity or other potential for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer such products. FDA analyses and investigations revealed that these products frequently contain the same APIs, or analogues of APIs, that are in FDA-approved drugs. Depending on the circumstances, these products are misbranded and unapproved new drugs, or adulterated food under the Federal Food, Drug, and Cosmetic Act. Note: Charge statement revised on 04/23/2019.
Country-specific information is available in the full alert detail on the FDA website.
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