FDA Alert: Suprimo Imports Warned by FDA After Reports of Illness and Death Due to Prescription Drug Ingredients in Their Dietary Supplements.

Dear Humberto Cecena:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://suprimoimports.com/, in January and April 2023, where you took orders for “AK Forte” and “Bob Marley CannaKing.” In addition, FDA has obtained a sample and labeling of your “AK Forte” product. As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

FDA confirmed through laboratory analysis that a sample of your “AK Forte” contains the undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and methocarbamol.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 “AK Forte” 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 “AK Forte” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.

Information on the label and/or labeling of “AK Forte” demonstrates that the product is marketed as a dietary supplement.2 Under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), if an article is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized.

FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988 and dexamethasone, under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as food before Voltaren and Hexadrol were approved, “AK Forte,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.

Unapproved New Drugs

“AK Forte” and “Bob Marley CannaKing” products 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 your website and product labeling of “AK Forte” and “Bob Marley CannaKing” that establish the intended use of these products as drugs include, but may not be limited to, the following:

On your webpage https://suprimoimports.com/ for “AK Forte”:

• “Pain Relief”

On the product labeling for “Bob Marley CannaKing”:

• “ARTHRITIS”
• “RHEUMATISM”
• “ANTI-INFLAMMATORY”
• “ALLEVIATES PAIN”
• “SCIATICA”
• “MUSCLE PAIN”
• “CARTILAGE REGENERATION”
• “REDUCES ANXIETY”
• “FIGHTS CANCER”
• “PARKINSON”
• “GLAUCOMA”

“AK Forte” and “Bob Marley CannaKing” 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 “AK Forte” and “Bob Marley CannaKing.” 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.

Misbranded Drugs

Your “AK Forte” product 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 “AK Forte” does not declare that the product contains the drug ingredients diclofenac, dexamethasone and methocarbamol. 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. Methocarbamol can cause sedation, dizziness, and low blood pressure. The failure to disclose the presence of diclofenac, dexamethasone and methocarbamol in the product’s labeling renders “AK Forte” misbranded under section 502(a) of the FD&C Act.

In addition, your “Bob Marley CannaKing” is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). “Bob Marley CannaKing” is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, “Bob Marley CannaKing” is not exempt from the requirement that its labeling bear adequate directions for use, because no FDA-approved applications are in effect for these products.

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).

We also documented that you offer the product “Artri Ajo King” for sale to consumers in the United States. Previous FDA laboratory analysis of “Artri Ajo King” revealed that it contains the undeclared ingredient, diclofenac.3 On April 20, 2022, FDA warned consumers not to purchase or use “Artri Ajo King” as FDA has received adverse event reports, including of liver toxicity and death, associated with the use of “Artri Ajo King” and similarly named products.4 While the Agency has not sampled and tested this product from your inventory to date, be advised of our serious concern about the safety of these products and that it is your legal responsibility under federal law to ensure this product does not contain any undeclared and potentially harmful ingredients.

A full list of all tainted products discovered by FDA can be found at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.

Conclusion

This letter is 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.

We offer the following additional comments:

Information on the label and/or labeling of “Bob Marley CannaKing” demonstrates that the product is marketed as dietary supplement. For example, the product is labeled as a “Dietary Supplement.” FDA has concluded that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), because, based on available evidence, CBD was not marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized.5 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.

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.

Sincerely,
/S/
CAPT Tina Smith
Acting Director, Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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1 U.S. Food & Drug Administration, Public Notification: AK Forte contains hidden drug ingredient, (April 13, 2023), https://www.fda.gov/drugs/medication-health-fraud/public-notification-ak-forte-contains-hidden-drug-ingredients.

2 “AK Forte” is labeled as dietary supplement on the product packaging.

3 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.

4 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/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug.

5 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.