As the FDA takes a closer look into CBD products this month, will it be designated a drug or a supplement?
This month the U.S. Food and Drug Administration will begin looking into the regulation of CBD oil and CBD products, but a decision earlier this month regarding omega-3 products may have some bearing on CBD being approved as a drug or a dietary supplement.
Over-the-counter products, like the omega-3 supplements in stores, are classified as a “food” by the FDA, while a number of companies produce FDA-approved medications containing omega-3s that may contain up to 90% omega-3 fatty acids. Over-the-counter supplements contain roughly 30-50% omega-3 fatty acids, depending on the product.
Weeks ago the U.S. Court of Appeals for the Federal Circuit ruled to uphold the U.S. International Trade Commission (USITC) 2017 decision not to investigate a complaint brought by a pharmaceutical company that alleged omega-3 products used unfair marketing practices because they were being sold as dietary supplements, according to Natural Products Insider.
“We…hold that a complainant fails to state a cognizable claim under §337 [of the Tariff Act of 1930] where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA,” Chief Judge Sharon Prost wrote in the opinion. “Such claims are precluded by the FDCA.”
The decision is seen as a win for the supplements industry and the ability of the FDA to interpret former rulings.
Amarin, marketer of Vascepa, an eicosapentaenoic acid (EPA) omega-3 drug used to lower high triglyercides, filed the complaint.
“Amarin was seeking to impose restrictions that could have created a market monopoly for pharmaceutical companies over a subset of omega-3 products, hindering responsible manufacturers from selling beneficial fish oil supplements and removed consumers’ abilities to buy affordable products that benefit their health and well-being,” said Steve Mister, president and CEO, the Council for Responsible Nutrition (CRN).
CBD products under FDA microscope
Regarding CBD and CBD products, the FDA will hold public hearings in May, create an internal working group to investigated legal marketing, update the Frequently Asked Questions part of the FDA website, and has already begun warning and fining CBD companies about “egregious and unfounded claims” made in their marketing.
CBD from marijuana has a scant research base due to cannabis’ classification as a dangerous drug since 1970.
To read the full story go to www.naturalproductsinsider.com/lipids/us-court-appeals-rejects-amarin-s-call-fish-oil-probe.
