CV Sciences Inc (CVSI)

[SpaceLady]

The CBD craze is getting out of hand. The FDA needs to act.
link text posted for those who cannot open the link.
By Scott Gottlieb July 30 at 5:33 PM
Scott Gottlieb, a resident fellow at the American Enterprise Institute, was the 23rd commissioner of the Food and Drug Administration from May 2017 to April 2019. He consults for and invests in biopharmaceutical companies.

Cannabidiol — better known as CBD — is everywhere, from small specialty shops to large national retail chains. It can be found in foods, supplements, drugs, oils, creams, pet foods and more, and sellers purport that the compound treats everything from cancer to depression. Analysts say the market could surpass $20 billion by 2024.

But many of the compound’s expansive benefits are fanciful, and in fact, the sale of much of the product is illegal under current law. The Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value that the compound might have.

Much CBD is derived from hemp, the commodity that was legalized in the 2018 farm bill. But the law still prohibits putting the chemical in food or pet food, and the FDA has issued repeated warnings and actions on the blooming CBD industry. In fact, there’s only one legally available purified form of CBD: the drug Epidiolex, approved by the FDA in 2018 to treat seizure disorders.

This doesn’t mean there can’t be a route for CBD to be legally sold in other forms, including as a food ingredient. Nor does it mean that CBD can’t offer potential benefits. But a legal path should be based on a clear and efficient regulatory process and sound science to guide its proper use.

CBD has risks: It can cause damage to the liver at high doses, and it may have a cumulative effect. If you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose. Currently marketed products might also have undeclared ingredients and impurities, including the psychoactive compound found in marijuana, delta-9-tetrahydrocannabinol (THC).

Any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous clinical trials to prove its therapeutic potential as a medicine. It’s not appropriate or legal to make such claims otherwise.

The conflict in grappling with these illegal products stems from the misperception that the 2018 farm bill fully “legalized” CBD. When Congress passed the bill, it established a category of cannabis from hemp defined by extremely low concentrations of THC. But in doing so, Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to make sure they’re safe and that their claims are valid.

Under current law, CBD is permitted in food or dietary supplements only if the FDA issues a regulation allowing its use. This is a multiyear process subject to notice and comment, requiring a substantial amount of scientific data that the FDA must evaluate.

Given the pressure on the FDA to create a more immediate path for CBD products, this route might simply take too long. But there is a way that the FDA can fulfill its public-health obligations and meet the political demand for these goods: It can approve the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation and a pathway for an enforceable market for these goods.

The FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food. These submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD. These are the same standards any new food ingredients are held to. Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.

In the meantime, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions. These criteria can include meeting good manufacturing requirements, demonstrating traceability, adhering to safe levels for the purity and potency of the CBD being added, and demonstrating that CBD is being added to food products only in very low concentrations that are unlikely to pose health risks.

In setting such a policy, the FDA could make clear that any CBD products that remain on the market — subject to a limited period of enforcement discretion — may not make any claims to treat disease. Other claims — for example, that it might help with relaxation — would have to be substantiated with evidence. This framework should also be expressly unique to CBD. Otherwise, there’s a risk it becomes a precedent for food and supplement makers seeking a back door to add other drugs to foods.

The FDA is being pushed by all sides to act quickly. Meanwhile, responsible food makers waiting for regulators to address the legal and safety considerations before launching CBD products are being eclipsed by unscrupulous purveyors. Obligating the industry to do the front end of this scientific work — and sweeping the market o f those who won’t — could advance a safe path and help establish the stable market for hemp-derived CBD envisioned by lawmakers.

Read more: