FDA continues to enforce CBD claims language as meeting on botanical is set for May

02-Apr-2019 - Last updated on 02-Apr-2019 at 16:57 GMT

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FDA has sent three companies marketing CBD products warning letters over disease claims. The warnings are the first issued under FDA’s de facto ‘enforcement discretion’ policy, which will be discussed at a meeting on CBD set for the end of May.

The three letters were posted on FDA’s website late last week. The letters, which were issued jointly by the Federal Trade Commission, focus on illegal disease treatment claims.

Non compliant claims

Advanced Spine and Pain, LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings, Inc. received the letters based on FDA’s review of the language on their websites.

Among the noncompliant claims cited in the warnings were:

“For Alzheimer’s patients, CBD is one treatment option . . .”
“[T]he therapeutic efficacy of CBD in the treatment of anxiety-related disorders . . .”
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”

Enforcement discretion

The warning letters continue a de facto FDA policy of restricting enforcement actions related to CBD and hemp products to what claims are being made on the products. The warning letters all feature boilerplate language to the effect that CBD has been determined to not be a legal dietary ingredient because it was previously investigated as a drug before coming to market as a supplement.

In a Senate hearing on Thursday, outgoing FDA Commissioner Scott Gottlieb, MD, said FDA is not moving against any marketer of CBD products based solely on the uncertain regulatory underpinning of the ingredient. While FDA’s reading of federal law is that the molecule is not a legal dietary ingredient, Gottlieb said, “We’re using enforcement discretion right now. I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims.”

Gottlieb in the past has said that a rule making procedure would be necessary to ‘fix’ the regulatory problems with CBD. He alluded to the fact that such procedures can last from three to five years or more, and if legislators want something done more quickly, passing a new law might be necessary.

Roadmap for the future

Dan Fabricant, PhD, president and CEO of the Natural Products Alliance, said that there is a precedent for the CBD situation. In the past, FDA made a determination of what the line between a red yeast rice supplement and lovastatin, a cholesterol-lower drug, should be. While some in the supplement industry might have rued how that turned out (‘legal’ red yeast rice cannot state the levels of monacolin K in the finished product, leaving consumers a bit on the dark as to efficacy), it does provide useful road map, he said. The delineation could be based on the final dosage, he said.

“Enforcement discretion in this instance means that you have a natural product that contains a level of a drug ingredient, like with the red yeast rice situation. There is a level at which that is a drug, and another where it can be a supplement,” he said.

That wouldn’t necessarily remove every regulatory barrier for CBDs, he said. The rules for hemp ingredients, just as with other new ingredients in supplements, would still apply, he said.

The issues surrounding CBD and hemp are set to become clearer with an upcoming meeting on the regulatory concerns surrounding the botanical set for May 31. The all day meeting will take place at FDA’s White Oak Campus in Silver Spring, MD.