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WARNING LETTER

Amazon.com, Inc. MARCS-CMS 631751 —

Delivery Method:
Via Email
Product:
Drugs
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

WARNING LETTER

October 28, 2022

RE: 631751

Dear Mr. Jassy:

This letter concerns your firm’s distribution of “Artri Ajo King Reforzado con Ortiga y Omega 3” (hereinafter “Artri Ajo King”), “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). As discussed below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). 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). You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

FDA purchased “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” products through your website, www.amazon.com. 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 “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” purchased on Amazon.com contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product labels.2

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. The undeclared diclofenac ingredient in “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Information on the labels and/or labeling of “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” demonstrates that the sampled products are marketed as dietary supplements.3 However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include 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. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. Prior to that date, diclofenac had not been marketed as a food or dietary supplement. Given that diclofenac was not marketed as a dietary supplement or as a food before Voltaren was approved, “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey,” which contain diclofenac, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.

Moreover, we note regardless of whether these products are excluded from the definition of a dietary supplement, they are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for, among other things, use as an arthritis treatment.4

Unapproved New Drugs

“Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” 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, of “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” that establish the intended use of these products as drugs include, but may not be limited to, the following:

“Artri Ajo King Reforzado con Ortiga y Omega 3” (Artri Ajo King):

“PROPRIEDADES” (English translation: PROPERTIES)

  • “Altamente eficaz en la reconstruccion del cartilago.” (English translation: Highly effective in restoring cartilage.)
  • “Combate la artritis.” (English translation: Fights arthritis.)
  • “Detiene el avance de deterioro en articulaciones.” (English translation: Stops the progress of joint deterioration.)
  • “Antiinflamatorio y analgesico.” (English translation: Anti-inflammatory and analgesic.)
  • “Eficaz en problemas de articulaciones de lesiones deportivas.” (English translation: Effective for joint problems due to sports injuries.
  • “Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.” (English translation: Benefits people suffering from degenerative processes such as arthritis and osteoarthritis.)
  • “Mejora la movilidad y normal funcionamiento de las articulaciones.” (English translation: Improves mobility and normal functioning of the joints.)

“Ortiga Mas Ajo Rey”:
Listed on the principal display panel directly beneath the product name:

  • “Dolor de Artritis” (English translation: Arthritis pain)
  • “Reumas” (English translation: Rheumatism)
  • “Gota” (English translation: Gout)
  • “Osteoartritis” (English translation: Osteoarthritis)
  • “Arteriosclerosis” (English translation: Arteriosclerosis)
  • “Ciatica” (English translation: Sciatica)
  • “Acido Urico” (English translation: Uric Acid)
  • “Dolor de Articulaciones” (English translation: Joint Pain)

“Artri King Reforzado con Ortiga y Omega 3”:

  • “Altamente eficaz en la reconstruccion del cartílago.” (English translation: Highly effective in restoring cartilage.)
  • “Combate la artritis.” (English translation: Fights arthritis.)
  • “Detiene el avance de deterioro en articulaciones.” (English translation: Stops the progress of joint deterioration.)
  • “Antiinflamatorio y analgesico.” (English translation: Anti-inflammatory and analgesic.)
  • “Eficaz en problemas de articulaciones de lesiones deportivas.” (English translation: Effective for joint problems due to sports injuries.)
  • “Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.” (English translation: Benefits people suffering from degenerative processes such as arthritis and osteoarthritis.)
  • “Mejora la movilidad y normal funcionamiento de las articulaciones.” (English translation: Improves mobility and normal functioning of the joints.)

“Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” 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 “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey.” Introduction or delivery of these products into interstate commerce without an approved application violates sections 301(d), 21 U.S.C. 331(d), and 505(a) of the FD&C Act.

In addition, “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” 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 respective labeling for “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” does not declare that the products contain the drug ingredient diclofenac. As discussed earlier, diclofenac (and other NSAIDs) can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death. The failure to disclose this ingredient in the products’ labeling renders “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” misbranded under section 502(a) of the FD&C Act.

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

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, 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, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/s/
Carolyn Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
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 discussed below was “fulfilled” by Amazon; your website states, “With Fulfillment by Amazon (FBA), [sellers] store [their] products in Amazon's fulfillment centers, and [Amazon] pick[s], pack[s], ship[s], and provide[s] customer service for these products” (see https://sell.amazon.com/fulfillment-by-amazon.html).

2 U.S. Food & Drug Administration, Public Notification: Artri Ajo King contains hidden drug ingredient, (January 5, 2022), https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-ajo-king-contains-hidden-drug-ingredient; U.S. Food & Drug Administration (@FDA_Drug_Info), Twitter (March 4, 2022, 3:07PM) https://twitter.com/FDA_Drug_Info/status/1499838990631026689; U.S. Food & Drug Administration, Consumer Alert: Artri Ajo King, Facebook (March 4, 2022), https://www.facebook.com/FDA/posts/328441589313206; U.S. Food & Drug Administration, Public Notification: Artri King contains hidden drug ingredient, (April 20, 2022), https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients; U.S. Food & Drug Administration, Public Notification: Ortiga Mas Ajo Rey contains hidden drug ingredient, (April 20, 2022), https://www.fda.gov/drugs/medication-health-fraud/public-notification-ortiga-masajo-rey-contains-hidden-drug-ingredient; U.S. Food & Drug Administration, Public Notification: Ortiga Mas Ajo Rey - Extra Forte contains hidden drug ingredient, (April 20, 2022), https://www.fda.gov/drugs/medicationhealth-fraud/public-notification-ortiga-mas-ajo-rey-extra-forte-contains-hidden-drug-ingredients; U.S. Food & Drug Administration, FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients, (April 20, 2022), https://www.fda.gov/drugs/drug-safety-and-availability/fdawarns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug.

3 The labeling of these products contains a Supplement Facts panel.

4 We also note that the labeling of these products appear to violate Amazon’s policies that prohibit dietary supplements with disease claims from being listed on amazon.com https://sellercentral.amazon.com/gp/help/external/G201829010?language=en_US.

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