Departing Food and Drug Administration (FDA) Commissioner Gottlieb reiterated many of the things we have blogged about here recently in his testimony before a Senate subcommittee this past Thursday. Among other things, Gottlieb acknowledged that:
- The FDA was exercising enforcement discretion with respect to the multitude of CBD oil products in the marketplace that the FDA considers to be unlawful. Gottlieb cited over-the-top claims such as those relating to cancer or Alzheimer’s, as those might prevent patients from seeking traditional therapies.
- The FDA was actively exploring various options to create a “pathway” that makes the use of CBD oil in foods and dietary supplements lawful. As we previously blogged, the use of CBD oil in an approved drug prior to its use in food or dietary supplements creates a regulatory problem. The FDA has said it can use rulemaking to potentially solve the problem, but that could take several years.
- Gottlieb reiterated his earlier statement that the best solution may be legislation. He said there is a high-level team at the FDA trying to think through creative solutions, including potential legislation.
- Gottlieb noted that one potential legislative solution might be to permit CBD oil in foods and dietary supplements at specific concentration, potency and purity levels, presumably well below the levels found in its use as a drug ingredient. Gottlieb cited fish oil as an ingredient that is present in both dietary supplements and drugs, though fish oil’s “dual use” did not require legislation or FDA rulemaking because fish oil had been used in dietary supplements prior to its approval as a drug, and so was exempt from the rule barring CBD oil’s use in food and dietary supplements.
Meanwhile, another national retailer jumped on the CBD oil bandwagon, announcing that it will begin selling nonedible CBD oil products in nine states. No doubt pressure will continue to build on Congress and the FDA to find some type of regulatory or legislative solution to broaden the type of CBD oil products that can be legally sold.