Botanical Be
FDA issued a warning letter to Botanical Be (Edgar H. Felix, El Paso, TX) regarding three products — 'Kuka Flex Forte,' 'Reumo Flex,' and 'Artri King Reforzado con Ortiga y Omega 3' — sold via botanical-be.com. Laboratory analysis confirmed the products contained undeclared diclofenac, a prescription NSAID, making them unapproved new drugs and misbranded under the FD&C Act. The products were marketed with disease-treatment claims for arthritis, rheumatism, sciatica, and pain relief without FDA approval. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (10)
[P]reventing the formation of antigens that can trigger rheumatic and arthritic conditions. . . . aids in reducing inflammation and pain.
[P]owerful anti-inflammatory properties, effectively relieving arthritic and muscular pain.
Formula 100% Efectiva Contra El Dolor
For Joints And for Arthritis and Sciatica Pain
It's [sic] really really help[s] way better than a gout medicine artri king
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.
Very effective, my husband and my father-in-law took it in 2 days and saw positive changes in their arthritic pain.
RELIEVE Joint Pain Arthritis & Ciatica [sic]
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.
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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