- Recipient:
-
Recipient Name
Edgar H. Felix
- Botanical Be
360 Jardin Bello
El Paso, TX 79932-2357
United States-
- Botanical.be@gmail.com
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
WARNING LETTER
December 21, 2023
RE: 671066
Dear Mr. Felix:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://botanical-be.com/ in July 2023, where you take orders for “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” products. In addition, FDA has obtained samples and labeling of your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” products. 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, the 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 “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” contains undeclared diclofenac. 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. This hidden drug ingredient 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 label and/or labeling of “Kuka Flex Forte” and “Reumo Flex” demonstrates that the products are marketed as dietary supplements.1 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. Given that diclofenac was not marketed as a dietary supplement or as food before Voltaren was approved, “Kuka Flex Forte” and “Reumo Flex,” which contain diclofenac, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.
Unapproved New Drugs
Your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” 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 from the product labeling, including on your website https://botanical-be.com/, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
Kuka Flex Forte:
• “[P]owerful anti-inflammatory properties, effectively relieving arthritic and muscular pain.”
• “[P]reventing the formation of antigens that can trigger rheumatic and arthritic conditions. . . . aids in reducing inflammation and pain.”
• “Considered one of the most potent natural anti-inflammatories, it is highly beneficial for arthritis, gout, rheumatism and other joint-related ailments.”
• “[I]t has analgesic (pain-relieving) and antirheumatic properties. . . . effective option for combating arthritis, rheumatoid arthritis and even osteoarthritis."
Reumo Flex:
• “RELIEVE Joint Pain Arthritis & Ciatica [sic]”
• “For Joints
And for Arthritis and Sciatica Pain”
Artri King Reforzado con Ortiga y Omega 3:
• “Formula 100% Efectiva Contra El Dolor” (English translation: 100% Effective Formula Against Pain)
• “Artri King Ortiga/Omega 3/Curcuma
It’s [sic] really really help[s] way better than a gout medicine artri king”
• “Artri King Ortiga/Omega 3/Curcuma
Very effective, my husband and my father-in-law took it in 2 days and saw positive changes in their arthritic pain."
“Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” are not generally recognized as safe and effective (GRASE) 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, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3.” Accordingly, introduction or delivery for introduction into interstate commerce of these products violates sections 301(d), 21 U.S.C. 331(d), and 505(a) of the FD&C Act.
Misbranded Drug
Your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” products 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 “Kuka Flex Forte,” “Reumo Flex”, and “Artri King Reforzado con Ortiga y Omega 3” does not declare that the products contain the drug ingredient diclofenac. 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. The failure to disclose the presence of diclofenac in the products’ labeling renders “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” misbranded under section 502(a) of the FD&C Act.
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).
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
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your 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 injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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/
CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_____________________
1 “Kuka Flex Forte” and “Reumo Flex” are labeled as supplements on the product packaging.
