Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your “Ossos-Sans” product 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 from the labeling, including the outer packaging, that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following: “Ossos-Sans”: • “Artritis” (English translation: Arthritis) • “Osteoporosis” (English translation: Osteoporosis) • “Osteoartritis” (English translation: Osteoarthritis) • “Fracturas” (English translation: Fractures) • “Inflamacion” (English translation: Inflammation) • “Reumos” (English translation: Rheumatisms) • “Golpes” (English translation: Bruises) • “Calambres” (English translation: Cramps) • “Regeneración de cartílago” (English translation: Cartilage Regeneration) • “Dolores Musculares” (English translation: Muscle Pains) “Ossos-Sans” is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Passage 2Your “Ossos-Sans” 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 “Ossos-Sans” does not declare that the product contains the drug ingredients diclofenac and methocarbamol. The failure to disclose the presence of diclofenac and methocarbamol in the product’s labeling renders “Ossos-Sans” misbranded under section 502(a) of the FD&C Act. 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).