Royal Diamond Imports, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

There is no food additive regulation that authorizes the use of kratom extract in food. We are not aware of any information to indicate that kratom extract is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that kratom extract is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30). We know of no basis for general recognition of safety for kratom extract based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published scientific literature, existing data and information do not provide an adequate basis to conclude that the use of kratom extract in food meets the criteria for GRAS status. Therefore, based on our review, the use of kratom extract in conventional food does not satisfy the criteria for GRAS status under 21 CFR 170.30.

Passage 2

Your 7-OH Tablets are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are "new drugs" under section 201(p) of the Act (21 U.S.C. 321(p)). Subject to certain exceptions not applicable here, new drugs 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 Act (21 U.S.C. 331(d) and 355(a)). There are no FDA-approved applications in effect for your 7-OH Tablets. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Act (21 U.S.C 355(a) and 331(d)).