The US Food & Drug Administration has reiterated concerns over what it claims is “the proliferation” of CBD-containing products on the US market being unlawfully marketed for therapeutic or medical uses.
The comments come in the same week that the FDA and Federal Trade Commission jointly issued a warning letter to Naples, Florida-based Rooted Apothecary LLC, advising the company it was selling unapproved CBD products online with unsubstantiated claims the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, and other conditions or diseases.
Lacking reliable scientific evidence
The FTC meanwhile expressed concern that the products were in violation of the FTC Act by using efficacy claims not substantiated by competent and reliable scientific evidence.
In a press release, acting FDA commissioner, Ned Sharpless, said: “Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance.
We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.”
CBD is currently marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. But as the FDA points out, it has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. It adds: “There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.”
Regulatory pathway
More encouragingly, the FDA used this week’s press release to signal to industry that it is speeding up its efforts to establish a regulatory pathway for CBD products , following months of uncertainty about legal status of the category.
FDA principal deputy commissioner Amy Abernethy, said:“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies.
“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”
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