CBD and Stem Cells Show How FDA‘s Enforcement Discretion is Misused by All
[Thursday, July 25, 2019]
This week FDA issued a detailed Warning Letter to one of the country’s most prolific sellers of CBD products, Cureleaf. The Cureleaf Warning Letter lists numerous violations of the drug laws namely in the lofty and mostly dubious claims made by the company for its CBD products and false attempts to label their products as dietary supplements, when they clearly are not. The Warning Letter can provide anyone with similar products a clear list of what is wrong with the CBD industry. But this is just one Warning Letter to one company. Amazon lists thousands of products containing various amounts of CBD making practically the same claims. CBD products are widely available in the market, both online and brick and mortar stores, and FDA has done little to enforce its own laws. FDA has taken its so-called loosely-defined policy of “enforcement discretion” for CBD products which creates enormous confusion in the public. This policy seems to show FDA allowing activities that it clearly defined as illegal. And this is not the only such case. Recent years saw the rise of hundreds of stem cell clinics selling various “treatments” against FDA’s stated policy of requiring clinical trials and market approval. These clinics still openly do business right under FDA’s eyes with no significant consequences. On one hand FDA insisted that stem cell therapies need its approval, and on the other hand, it announced that it will not take any action for years against violators of its regulations, literally giving illegal businesses a reasonable timeframe to monetize before closing shops and leaving patients in a limbo. Similarly, by not taking any significant action against sellers of CBD products, FDA is in fact encouraging manufacturers of these products to cash out at the expense of innocent patients looking for alternative treatment options to their incurable diseases. Its about time there be a clear definition of when the so-called enforcement policy is needed and when it should be restricted. The apparent arbitrarily nature of these policies does not help patients or the industry, while it chips away at FDA’s credibility as a neutral enforcer of the rules it wrote.