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.Įxamples 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,” “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, among other things, use as an arthritis treatment. 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. 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. Prior to that date, diclofenac had not been marketed as a food or dietary supplement. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. 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.

3 However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C.

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. 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. 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. 2ĭiclofenac is a non-steroidal anti-inflammatory drug (NSAID). 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 contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product labels. You can find the FD&C Act and FDA regulations through links on FDA’s home page at FDA purchased “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” products through your website, These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.

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. Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. 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. 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”). Issuing Office: Center for Drug Evaluation and Research | CDER

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