FDA Warns another CBD Manufacturer but does it Address the Broader Issue
[Thursday, October 24, 2019]
This week FDA and FTC jointly issued a Warning Letter to another CBD manufacturer for selling CBD as an unapproved drug for pediatric diseases among other claims, and for selling CBD as a dietary supplement. This warning letter is similar to other warning letters issued by FDA in recent years to manufacturers of CBD containing products, but this barely touches the tip of the iceberg as CBD products continue to sell freely online and in retail stores. The Warning Letter basically only tells the manufacturer to stop making medical claims for its products but stops short of cease and desist for all sales. It does not tell the manufacturer that it cannot sell CBD products but just that it needs to take down medical claims. FTC added to the letter advertisement related issues mainly around making unsubstantiated claims. The letter gives the manufacturer a way out to stay in business by selling CBD products by just not making explicit medical claims. CBD products have sufficient publicly available information to confuse most consumers. CBD products are widely available and so is information about their “benefits”. So, as long as a manufacturer is able to keep its products in the market, these kind of actions by FDA do very little to address the broader issue of regulating CBD. And it is not easy for FDA. Almost all the states in the country allow marijuana partially or freely even for recreational uses; so, for FDA to make stricter rules for the safer component of marijuana, namely CBD, is practically impossible. Yes, FDA can continue to regulate medical claims and FTC can continue enforcing truthfulness in advertisements, but manufacturers can easily scoot around those provisions and continue in the market trying to push the envelope as far as possible. Should CBD be simply deregulated just like marijuana? FDA can make some broad outline of the acceptable claims and allow most consumers and physicians to make their own decisions about these products, just like they do for alternative treatment options and supplements. May be FDA is just wasting its resources by trying to treat CBD as a conventional pharmaceutical, when it should be treated as a complementary treatment. The answers reside with FDA’s brass or may be with Congress that can pass laws to deregulate CBD as a pharmaceutical.