DMHA Gets FDA Attention At Alternative Labs, CBD Noticed While There
Warning doesn't reference any noncompliant claims for CBD-labeled Green Roads, but FDA explains the basis for which it has stated for two years it could warn every firm marketing products that are labeled as or found containing CBD.
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Plaintiffs against Florida-based Green Roads used certificates of analysis the company makes freely available to consumers to determine that batches of two of the company’s products contained “significantly” less cannabidiol versus labeled amounts. A Florida federal court rejected the firm’s motion to dismiss, but it is interested in seeing how FDA rulemaking develops.
Plano, TX, own-labeler's Smart Caps declared dietary ingredient "Octrodine," also known as 1,5-dimethylhexylamine, or DMHA. Revial's two responses failed to satisfy the agency's concerns about its GMP compliance.
Warning is second FDA submitted in September referencing CBD as unlawful for use in supplements without also identifying non-compliant claims. It