Will Hemp CBD’s Regulatory Controversy Help or Hurt Its Future as a Supplement Ingredient?

FDA may not recognize hemp cannabidiol (CBD) as a dietary supplement ingredient, but that hasn’t stopped the ingredient from shooting up the supplement sales charts in recent years. In fact, the many headlines on CBD’s shaky legal status on the supplements market may actually be helping sales. The question, though, is how much that growth can continue if the ingredient’s regulatory baggage continues to follow it.

Several supplement products containing hemp CBD, a non-psychoactive component of Cannabis sativa, have become the target of FDA scrutiny in recent years, including, most recently, warning letters the agency sent to eight companies marketing CBD foods and dietary supplements earlier this year. In FDA’s opinion, hemp CBD is excluded from the definition of a dietary supplement ingredient because of existing authorizations for investigational new drugs (INDs) containing CBD. Those IND authorizations, for GW Pharmaceuticals’ Sativex and Epidiolex, were made public on November 26, 2007 and May 24, 2014, respectively. Although FDA says it would allow CBD supplements if it had evidence of such products being marketed prior to the IND dates, the agency concluded this was not the case and therefore CBD cannot be sold in foods or supplements.

In response, many within the hemp CBD supplements industry have challenged FDA’s timeline, claiming CBD was in fact marketed as a dietary supplement before the IND authorizations went public. That leaves us with the current standoff-a U.S. market where hemp CBD supplements are selling well in the face of FDA resistance. But going forward, will the regulatory controversy continue to be as favorable to CBD supplement business?

Business is Booming

While it might seem like hemp CBD supplements would be attracting negative public attention as a result of FDA warning letters citing the ingredient’s murky regulatory status, the controversy has actually been great for business, said Stuart Tomc, vice president of human nutrition for CBD oil supplier CV Sciences (Las Vegas). He explains that every time hemp CBD supplements have made headlines presented an opportunity for the industry to get more exposure. With that in mind, is all publicity good publicity?

“Well, I don’t really like that adage,” Tomc told Nutritional Outlook at the SupplySide West trade show. “But I guess it’s a little true in this case.” He adds that the recent media exposure for hemp CBD has helped CV Sciences get to the point where it is today-supplying CBD ingredients for products that can be found in around 800 health food stores.

Still, the regulatory controversy has been enough to keep some major retailers from picking up CBD supplements products, including Vitamin Shoppe, GNC, and Whole Foods, Tomc noted. That’s okay, for now, Tomc said, because interest in CBD supplements is still building and CV Sciences has managed to achieve success with smaller, independent retailers.

CV Sciences disagrees with FDA’s position that the CBD drug applications publicized by GW Pharmaceuticals predate marketing of CBD as a supplement or food product, but Tomc said FDA’s stance is also not an issue he’s incredibly concerned with.

For one, he argued that Sativex, the subject of an IND made public in 2007, contains both THC and CBD and is therefore not a comparable formula to the hemp CBD found in most supplement products. With that objection and others to FDA’s CBD timeline, he believes the case will eventually make it to a jury, with a ruling that negates the IND preclusion against hemp CBD products marketed as dietary supplements.

An Uncertain Future

On the other hand, not everyone is so optimistic about the future of hemp CBD supplements. Marc S. Ullman, counsel at the New York–based law firm Rivkin Radler, said he is “concerned with the long-term prospects” of companies that continue to market hemp CBD products as dietary supplements. Ullman spoke on a panel titled Channels of Trade for Consumption of Cannabis as a part of the American Herbal Product Association’s (AHPA; Silver Spring, MD) Botanical Congress at SupplySide West.

“I have yet to see any company that continues to market CBD put forward any serious evidence that this ingredient was marketed as an article used in food prior to these IND applications,” Ullman told Nutritional Outlook. “Marketing of hemp stalk oil is not sufficient-the evidence must relate directly to CBD. Absent this evidence, I am not optimistic that there is a legal basis for overcoming FDA’s position.”

Nonetheless, he suggested there may be an alternative pathway for CBD supplements besides contesting the timeline of the INDs versus a history of marketing as a food or supplement. Instead, the industry could “undertake a serious effort to differentiate naturally occurring CBD from whatever it is that GW [Pharmaceuticals] is pursuing as a drug.”

Rebrand as Hemp Stalk Oil?

For companies willing to cede a little ground and give up the CBD name, there could be a third option: “Revise marketing to remove all reference to CBD and offer their products as hemp stalk oil,” Ullman explained. This would carry challenges of its own, such as finding proof that hemp stalk oil was marketed before the passage of the Dietary Supplement Health and Education Act (DSHEA) in October of 1994, or submitting a New Dietary Ingredient notification for hemp stalk oil. But it might allow hemp supplement companies to sidestep the CBD controversy altogether.  

Ullman added that while he has “concerns over the long-term viability of CBD products,” he has a “very optimistic” outlook for the future of hemp stalk oil products.

Read more:

5 Hemp CBD Research Areas for Further Supplement Growth

Will Hemp CBD Be a Drug or a Dietary Supplement Ingredient?

FDA’s Latest CBD Warning Letters Cite Health Claims, Drug Applications

U.S. Hemp Food, Beauty Sales Climbed to $283 Million in 2015

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com