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The phytocannabinoid CBD (cannabidiol), one of the most significant organic ingredients in pharmaceuticals, one fine example, Epidiolex, was on its way of becoming an additive in food, beverages and even dietary supplements, but nearly all hope was lost after the FDA put out word against such prospects.
Last week in November, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing CBD, stating they had violated the Federal Food, Drug and Cosmetic Act. At the same time, the FDA published a revised Consumer Update detailing broad safety concerns about CBD products.
UNKNOWN HEALTH EFFECTS, MORE RESEARCH NEEDS TO BE DONE
The federal government has not come to terms with whether or not CBD is “generally recognized as safe” (GRAS) for use in human or animal food. Therefore, CBD in food and drink is still illegal.
The FDA says these new CBD products have not been reviewed for safety and may cause harm to consumers, such as liver damage, and that not enough information is known about the health effects of taking CBD. For example, the long term effects on the body, the effects on particular individuals, for example breast-fed babies, and how it interacts with other drugs.
Former FDA Commissioner Scott Gottlieb implied that it could take the agency years before it can establish a “benefit vs risk” profile that would make it possible to implement regulations on CBD as a food additive.
ILLEGAL HEALTH CLAIMS ON LABELS (MISLABELING OF PRODUCTS)
While CBD has been found effective, with the FDA having approved one prescription drug derived from CBD, brand named Epidiolex, which treats two rare and severe seizure disorders in children over the age of 2, there is no concrete evidence that cannabidiol will prevent diseases such as diabetes, shrink tumors, wean a person off opioids, ease schizophrenia or calm anxious pets – despite the claims of companies actively marketing CBD products.
Laura MacCleery, policy director for Center for Science in the Public Interest, said CBD products have been marketed for children’s use and for pregnant women and that researchers haven’t adequately studied either use. She said there are concerns about CBD and liver toxicity, and problems with supply chain quality control. Some products may be mislabeled, with more or less CBD than indicated. There are also concerns about contaminants, and since labels are often unclear whether the CBD is derived from marijuana or hemp, heavy metals may be a concern (marijuana is an effective extractor of heavy metals from soil).
The FDA states that they will continue monitoring the marketplace and taking necessary action against unlawful companies. They remain concerned about the unawareness of consumers of claimed FDA-approved CBD products.
EFFECT ON CBD INDUSTRY
Of course, there was the foreseeable dispute between CBD companies and the FDA concerning the agency’s silence on where does CBD stand in a matter of its safeness, so these companies can know what do when labelling and marketing their CBD products.
The Council for Responsible Nutrition, the trade association for the dietary supplement industry, said the FDA’s move unnecessarily alarms consumers. They argue that the FDA’s inaction for the past year has facilitated an unregulated marketplace, which is bad for consumers and the burgeoning CBD industry.
Melissa Bane, managing director of market research and consulting firm Grail Insights, said the FDA crackdown will likely have little effect on the industry’s growth.
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