Ullman Quoted in NutraIngredients-USA

June 28, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “FDA says Gottlieb statement does not signal CBD enforcement shift, but some questions unanswered, observers say.”

A statement by FDA Commissioner Dr. Scott Gottlieb noted that the US Food and Drug Administration has approved the first CBD drug, which was developed by English company GW Pharmaceuticals. The drug was approved to treat two rare forms of seizure disorder in children ages two years and older.

Dr. Gottlieb noted, “This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.

Ullman responded with, “They said they are going to continue to watch for CBD products that make crazy drug claims. The statement suggests FDA will only take action if you both have CBD in your product and you make an unapproved drug claim. And that’s baffling. If that is indeed FDA’s approach then the agency needs to say so. If anything, this muddies the water. There has got to be a clearer way to say ‘we are exercising enforcement discretion.”

Click here to read the full article.

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