Expert in FDA Law Formulated ABCs of CBD at Mingle
Author: Bob Benenson, Naturally Chicago
March 10th, 2020
Since launching his first law firm in 1998, Rakesh Amin has built a practice representing hundreds of companies that produce food and beverages, dietary supplements and cosmetics. His work in this sector has earned him regard as the nation’s leading expert in law pertaining to the regulatory authority of the U.S. Food and Drug Administration (FDA).
It also enabled him to get ahead of the curve on the rapid rise of CBD, a hemp derivative touted by its advocates for having life-enhancing benefits.
His Chicago-based firm, Amin Talati Wasserman, is legal counsel to the U.S. Hemp Roundtable, which describes itself as “a coalition of leading companies and organizations committed to safe hemp and CBD products.” The Hemp Roundtable played a key role in persuading Congress to insert a provision into the 2018 Farm Bill lifting a longstanding (and controversial) ban on production of industrial hemp.
With CBD one of the hottest topics in the Natural Products sector, Amin — a member of the Naturally Chicago Board of Directors — spoke at a Friday Morning Mingle February 21 about the complex legal status of CBD.
Amin explained that there are three major legal issues that he and other hemp advocates are working to resolve.
First, there is the technical issue of “IND preclusion.” FDA hsa taken the position — via Warning Letters sent to hemp-CBD companies and the agency’s Q&A posting — that a product containing CBD was approved as a drug, and substantial clinical trials studying CBD as a new drug were made public prior to the marketing of any food or dietary supplements containing CBD. Therefore, FDA has determined that dietary supplements or food are therefore precluded from containing CBD as an ingredient (what is known as the “IND Preclusion”).
Amin disagrees that the referenced clinical trials are in fact “substantial,” as the trials were extremely limited in scope, and funding and the publication of these trials were limited. Amin also believes FDA seems to misinterpret the IND Preclusion. He says FDA believes the preclusion date is simply the date in which it authorized CBD as an IND, without giving deference to the remaining portion of the statute, which requires that substantial clinical investigation be commenced and that such substantial clinical investigation be made public.
Because little research has been done to date on potential health benefits and negative impacts from CBD, the FDA is approaching the issue with an abundance of caution — to which Amin is sympathetic.
“I think it is likely that FDA will issue a regulation allowing CBD to be marketed as a dietary supplement ingredient. If that doesn’t happen, then we will see Congress step in via a targeted legislation ,” Amin said. “But I think it may take a little while. FDA needs to be comfortable with the safety evidence, and they need to be comfortable that they’re just not going to get egg on their face.”
The bigger issues for CBD producers, Amin said, are product claims for which there is arguably not yet sufficient scientific evidence. Amin provided words to the wise CBD manufacturer to avoid anything that could be deemed an unsubstantiated or spurious claim.
“For CBD and hemp, make it a priority to source it properly, do the quality testing and confirm safety. Additionally, the functionality claims made for CBD, even if merely structure-function claims, will be heavily scrutinized by government officials, such as the U.S. Federal Trade Commission and state attorneys general, and also by class action shakedown lawyers,” Amin warned.
He continued, “Thus, you should minimize claims and be cautious about it, and get labeling and advertising reviewed [by lawyers] to reduce risk with softer, less-aggressive claim language.”
Speaking of CBD, Amin said, “It should be embraced. It is a great material, and here to stay as part of food technology and innovation. It has many useful applications that deal with health and wellness. But it is a young category and young material… So I think it needs to mature a bit, the science needs to come together.”
So, he counseled CBD producers, “Get on higher ground, step back, be better at issue spotting, put better things in your war chest than just money, put good facts. Taking away words on your labeling, packaging and marketing can be a really good fact.”
Amin Talati Wasserman welcomes inquiries from CBD producers about compliance and intellectual property legal issues involving their products and product claims. You can contact them at rakesh@amintalati.com.
