Natural Products Insider

JAN-FEB 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 19 Now that the 2018 Farm Bill has been signed into law, and hemp has been removed from the federal Controlled Substances Act (CSA), the temptation to start selling hemp-derived cannabidiol (CBD) products is understandable. Consumer interest in CBD shows no sign of waning. But here's the rub: FDA insists CBD may not lawfully be sold in food or dietary supplements. In a public statement issued the same day the Farm Bill was enacted, FDA Commissioner Scott Gottlieb, M.D., announced, "It's unlawful under the Federal Food, Drug and Cosmetic Act (FD&C Act) to introduce food containing added CBD or THC [tetrahydrocannabinol] into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived." Gottlieb explained, "Both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it's illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements." In other words, if the "article" was fi rst studied for drug purposes, it's prohibited as a food or supplement. Some creative marketers have sought to avoid the potentially negative legal attention from marketing CBD as an enumerated ingredient on their labels. They choose instead to market their products as "full-spectrum hemp" extract. Seemingly, this approach might indeed dodge the legal conundrum altogether—after all, "full- spectrum hemp" is not the "article" that was being studied in those drug trials; it was relatively isolated CBD or THC. But the prisoner's dilemma is not solved so easily. Remember in the classic psychological game, each prisoner is tempted to talk, to spill the beans on the other and commit the other prisoner to additional jail time. If a company is selling "full-spectrum hemp," can it still make the same claims as it would for CBD? Unfortunately, the medical literature is lean on research that supports claims for "full-spectrum hemp" as opposed to CBD or other isolated cannabinoids. And in all the excitement to meet consumer desire for products, it's easy to forget fundamental labeling and advertising requirements that the substantiation for a claim must match the ingredient identity and dosage amounts in the product. If a brand wants to avail its "full-spectrum hemp" products of the substantiation research available specifi cally for CBD, then one would have to standardize that "full-spectrum hemp" product to ensure that it reliably and consistently delivers the same levels of CBD utilized in the underlying research. To do that requires isolating and standardizing those CBD levels, which means, in FDA's eyes, they are now selling CBD—the very "article" FDA says is off limits to food and supplements. This is exactly the dilemma that has plagued marketers of red yeast rice for the past 18 years. Since the Pharmanex decision was handed down by the 10th Circuit in 2000, FDA has prohibited supplement manufacturers from manipulating the levels of lovastatin in red yeast rice for exactly this reason. To do so would be to market the "article" FDA says can only be sold as a drug. Fortunately, there is a way out of this dilemma. And that's conducting research on what truly is full-spectrum hemp extract. Even as the industry engages with FDA to fi nd an alternative pathway to market for CBD, the industry will do well to commit itself to study carefully this golden goose before the prisoner's dilemma catches them for good. Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN,, a trade association for the die tary supplement and functional food industry. Legal Science, CBD and the Prisoner's Dilemma by Steve Mister LIVE WEBINAR Premium Series W E B I N A R CBD is Out of the Block— Can Science Catch Up? Date: February 26, 2019 Time: 2 pm — 4 pm EST CO-SPONSORED BY: To register, visit

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