Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].
Passage 2Accordingly, your products Raw Honeycomb; Tupelo Honey Raw; and Superfood Honey with Royal Jelly, Bee Pollen, Propolis fail to bear adequate directions for their intended use and therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.5