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WARNING LETTER

Amazon.com, Inc. MARCS-CMS 662503 —

Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Andy Jassy
Recipient Title
CEO
Amazon.com, Inc.

2021 7th Ave
Seattle, WA 98121-2601
United States

Regulatory-inquiries@amazon.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States

WARNING LETTER

December 20, 2023

RE: 662503

Dear Mr. Jassy:

This letter concerns your firm’s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products that are labeled as energy enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). Your firm is also responsible for introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).

FDA purchased “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” “Mens Maximum Energy Supplement,” and “X Max Triple Shot Energy Honey” through your website, www.amazon.com. All of these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.1 FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,”2 “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients are not declared on the products’ labeling.3 Sildenafil and tadalafil are phosphodiesterase type-5 (PDE-5) inhibitors and the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

Information on the labels and/or labeling of “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” demonstrates that these products are marketed as dietary supplements4. However, these products do not meet the definition of “dietary supplement” under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). Under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a product is not a dietary supplement if it includes an article that is approved as a new drug under section 505 of the FD&C Act, unless that article was marketed as a dietary supplement or food before its approval as a drug. Sildenafil and tadalafil were not marketed as dietary supplements or as foods before Viagra and Cialis were FDA-approved. FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. FDA approved Cialis (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. Given that sildenafil and tadalafil were not marketed as dietary supplements or as foods before Viagra and Cialis were FDA-approved, “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement,” which contain sildenafil or tadalafil, are excluded from the definition of “dietary supplement” under section 201(ff)(3)(B)(i) of the FD&C Act.

The remaining product, “X Max Triple Shot Energy Honey,” is a food5 that was confirmed by laboratory analysis to contain tadalafil.

Unapproved New Drugs

The “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products that are marketed as dietary supplements are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims observed on the labeling, including the outer packaging, that establish the intended use of these products as drugs include, but may not be limited to, the following:

“MANNERS Energy Boost”
From the product label:

  • “Energy Boost”

“Round 2”
From the product label:

  • “THE POWER TO GO AGAIN! STRENGTH * ENERGY * ENDURANCE”

“WeFun”
From the product label:

  • “Energy[,] Performance”

“Genergy”
From the product label:

  • “ENERGY FOR MEN”

“Big Guys Male Energy Supplement”
From the product label:

  • From the product name: “Male Energy Supplement”
  • “Extreme Power”
  • “Focus . . . Energy . . . Mood”
  • “500 MG POWER BOOST”

“Mens Maximum Energy Supplement”
From the product label:

  • The product name: “Mens Maximum Energy Supplement”
  • “NEVER ENDING ENERGY!”
  • “STRENGTH[,] ENERGY[,] ENDURANCE”

“MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement.” Introduction or delivery of these products into interstate commerce without approved applications violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Drugs

Additionally, “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for these products does not declare that they contain PDE-5 inhibitors. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in these products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. The failure to disclose these ingredients in the products’ labeling renders them misbranded under section 502(a) of the FD&C Act.

“MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for their intended uses. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs. “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement,” which contain undeclared sildenafil or tadalafil, are also prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, and as such, can be used safely only at the direction and under the supervision of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” such that a layperson can use these drugs safely for their intended uses. These products are not exempt from the requirements that their labeling bear adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there are no FDA-approved applications in effect for these products. For these reasons, “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are misbranded under section 502(f)(1) of the FD&C Act.

The undeclared sildenafil or tadalafil in “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” also causes the products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. As previously noted, there is a potential for serious health risks associated with these products, particularly since anyone who takes these products would be unaware of the presence of the undeclared drug ingredients and placed at risk for the associated adverse events.

The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Prohibited Act under Section 301(ll)

It is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. As noted above, FDA purchased “X Max Triple Shot Energy Honey” from www.amazon.com and confirmed through laboratory testing that the product contained undeclared tadalafil. Based on available evidence, FDA has determined that the prohibition in section 301(ll) applies to tadalafil.6 The introduction or delivery for introduction into interstate commerce of “X Max Triple Shot Energy Honey” is therefore prohibited under section 301(ll) of the FD&C Act.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. 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/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients, as well as copies of related documentation. If you believe that the products you distribute are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.

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.

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

____________________________

1 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” (See https://sell.amazon.com/fulfillment-by-amazon).

2 On August 25, 2023, Hua Da Trading Inc., dba WeFun Inc., issued a voluntary nationwide recall of WeFun Capsules due to the presence of undeclared sildenafil (see https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hua-da-trading-inc-dba-wefun-inc-issues-voluntary-nationwide-recall-wefun-capsules-due-presence).

3 U.S. Food & Drug Administration, Public Notification: MANNERS Energy Boost contains hidden drug ingredient (February 2, 2023), https://www.fda.gov/drugs/medication-health-fraud/public-notification-manners-energy-boost-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: Round 2 contains hidden drug ingredient (August 22, 2023),https://www.fda.gov/drugs/medication-health-fraud/round-2-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: Genergy contains hidden drug ingredient (August 23, 2023), https://www.fda.gov/drugs/medication-health-fraud/genergy-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: X Max Triple Shot Energy Honey contains hidden drug ingredient (August 23, 2023), https://www.fda.gov/drugs/medication-health-fraud/x-max-triple-shot-energy-honey-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: WeFun contains hidden drug ingredient (August 23, 2023) https://www.fda.gov/drugs/medication-health-fraud/wefun-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: Big Guys Male Energy Supplement contains hidden drug ingredient (August 23, 2023), https://www.fda.gov/drugs/medication-health-fraud/big-guys-male-energy-supplement-contains-hidden-drug-ingredient;
U.S. Food & Drug Administration, Public Notification: Mens Maximum Energy Supplement contains hidden drug ingredient (August 23, 2023), https://www.fda.gov/drugs/medication-health-fraud/mens-maximum-energy-supplement-contains-hidden-drug-ingredient.

4 The labeling for each of these products includes a Supplement Facts panel.

5 The labeling for this product includes a Nutritional Information panel.

6 There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for tadalafil.

 
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