Latin Foods Market

This letter concerns a product that your firm distributes to consumers via your website, latinfoodsmarket.com. The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, “Artri King Reforzado con Ortiga y Omega 3.” As described below, this product is an unapproved new drug sold in violation of sections 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, this product is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering this product 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 King Reforzado con Ortiga y Omega 3” through your website, latinfoodsmarket.com. FDA confirmed through laboratory analysis that a sample of your “Artri King Reforzado con Ortiga y Omega 3” contains the undeclared active pharmaceutical ingredients diclofenac and dexamethasone, which are not listed on the product label.1

Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “Artri King Reforzado con Ortiga y Omega 3” may cause serious side effects when combined with other medications.

Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). 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 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.

“Artri King Reforzado con Ortiga y Omega 3” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is 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 King Reforzado con Ortiga y Omega 3” that establish the intended use of the product as a drug include, but may not be limited to, the following:

“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.)

“Artri King Reforzado con Ortiga y Omega 3” is not generally recognized as safe and effective for its above referenced uses and therefore is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug 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 this product. Introduction or delivery of this product into interstate commerce without an approved application violates sections 301(d), 21 U.S.C. 331(d), and 505(a), 21 U.S.C. 355(a) of the FD&C Act.

In addition, “Artri King Reforzado con Ortiga y Omega 3” is 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 “Artri King Reforzado con Ortiga y Omega 3” does not declare that the product contains the drug ingredients diclofenac and dexamethasone. As discussed earlier, diclofenac 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. Dexamethasone can cause serious adverse events, including infections, increased blood glucose levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction. The failure to disclose the presence of diclofenac and dexamethasone in the product’s labeling renders “Artri King Reforzado con Ortiga y Omega 3” 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 this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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/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 your products 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.