Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your websites and social media accounts establish that your products, “ApelinDx metered dose inhaler,” “Maia CBD Tincture Inhaler,” “Maia CBD Oil,” “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” “Maia Gummies,” and “CBD Pill” (hereinafter referred to as “your CBD products”), are unapproved new drugs introduced or delivered for introduction into interstate commerce 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).
Passage 2your CBD products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use.
Passage 3your “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” food products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive.
Passage 4it is a prohibited act to introduce your “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
Passage 5your website, www.thriftmasterholdings.com, and social media websites make claims that your CBD products may be intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 170.30
- 21 CFR 170.30(a)
- 21 CFR 181
- 21 CFR 201.5
- 21 CFR 201.100(c)(2)
- 21 CFR 312.2