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Will Hemp CBD Be a Drug or a Dietary Supplement Ingredient? - See more at: http://www.nutritionaloutlook.com/regulatory/finding-home-hemp#sthash.AGAdwsvC.dpuf

For an ingredient that isn’t officially approved for use in the United States, hemp CBD is quickly gaining ground in the dietary supplement market. Health food retailers across the country have begun carrying CBD supplements in recent years, even if FDA hasn’t actually recognized hemp CBD as a legal ingredient.

Hemp CBD, short for cannabidiol, occupies something of a legal grey area, due in large part to its associations with marijuana and CBD’s chemical cousin, tetrahydrocannabinol (THC). Both marijuana and industrial hemp are varieties of the Cannabis sativa plant, but the industrial hemp most CBD is derived from contains only minute amounts of THC and is therefore not psychoactive.

As public perception has warmed to the broader hemp category in recent years, FDA has taken a relatively hands-off approach to CBD supplements. However, those days may be coming to an end. FDA is currently considering an investigational new drug (IND) application for hemp CBD, which has already prompted the agency to speak out against CBD in dietary supplements. And if the IND is accepted, some industry experts fear the door could close on CBD ever reaching legal acceptance as a food or dietary supplement ingredient.

The Current Grey Area

CBD’s rise to prominence has come at a time when the hemp category as a whole is experiencing strong and steady growth. According to the Hemp Industries Association (HIA; Summerland, CA), U.S. sales of hemp food and body care products grew by 21.2% in 2014 to reach $200 million. Hemp seed products are stealing the spotlight, but there’s a lot to love about CBD as well. Recent research has shown CBD’s potential benefits on anxiety, sleep regulation, heart health, and more.

It may then be surprising that CBD dietary supplements have been able to reach U.S. consumers without being deemed generally recognized as safe (GRAS) by FDA, without being established under a new dietary ingredient (NDI) provision, and, depending on interpretation, while still being considered a Schedule 1 drug on the same list as marijuana and LSD. Many U.S. states have legalized the growing of hemp for research purposes, and there are several proposed bills in congress to legalize cultivation of industrial hemp nationwide. As of now, however, hemp CBD is an ingredient without legal standing.

And yet, FDA has mostly steered clear of taking action against hemp CBD supplements, says Eric Steenstra, executive director, HIA. Even earlier this year, when FDA sent warning letters to a slew of firms that market CBD products, it was on the basis of problematic disease claims, not CBD’s shaky legal status.

“The only indication we have from FDA on [CBD] is that they did send out a handful of letters to some companies that made specific health claims, but they could do that on any food or dietary supplement product based on the regulations about health claims,” says Steenstra. “It didn’t have anything to do with them objecting to CBD—they just objected to the health claims.”

Meanwhile, the CBD industry has been marching forward. While much of the CBD-rich oil in U.S. products is imported from Europe or China, companies like CannaVest (San Diego) have begun growing hemp in Kentucky or Colorado for research purposes—research that can even extend to sales and marketing of hemp, according to Chris Boucher, vice president of product development, CannaVest. With much of the infrastructure and supply chain in place, Boucher says the CBD industry is ready to explode.

“I think if it does become legal, we’re talking, potentially, a billion dollar industry without a doubt,” says Boucher.

FDA Draws Line

In May, FDA did finally offer some clarification on the status of CBD as an ingredient. Unfortunately for firms that produce hemp CBD dietary supplements, it’s not what they might have hoped for.

“Based on the available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the [Food, Drug, and Cosmetic Act],” says the statement from FDA, published in an online Q&A about the agency’s treatment of marijuana. The reasoning? Companies have already filed investigative new drug (IND) applications to make CBD a drug ingredient, such as those submitted by GW Pharmaceuticals for its Sativex and Epidiolex products.

FDA’s statement continues, “under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”

Essentially, because CBD is under consideration as a drug ingredient it cannot be considered a dietary supplement ingredient. Even more troubling, if FDA is already speaking out against CBD supplements now, while the drug application has yet to be approved, what happens if GW Pharmaceuticals is successful and CBD becomes accepted as a drug ingredient?

“If they [GW Pharmaceuticals] do get [the IND application] first, and it’s not on the market as a dietary supplement, it could preclude it ever being a dietary supplement, based on DSHEA [the Dietary Supplement Health and Education Act of 1994],” says Mark Blumenthal, founder and executive director, American Botanical Council (Austin, TX).

Still, the battle isn’t over yet. There’s an argument to be made for CBD being recognized as a supplement ingredient and not a drug ingredient, and it all comes down to timing.

Which Came First?

Under DSHEA, the law would allow CBD to be sold as a dietary supplement ingredient—based on grandfathered status and without NDI notification—so long as a company could prove that CBD was sold on the market as a dietary supplement ingredient prior to 1994.

Similarly, FDA’s May statement actually does leave some room for the possibility of CBD supplements—if the industry can show CBD supplements were on the market before GW Pharmaceuticals began its investigation into CBD for drugs.

“There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized,” says FDA in the same marijuana Q&A. Although the statement goes on to say FDA is not currently aware of any such evidence for CBD, it also invites interested parties to submit any information that might call into question that conclusion.

FDA has not specified the exact date when the drug ingredient process began, but it was likely between 2006 and 2008, says CannaVest’s Boucher. Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), says it is AHPA’s understanding that the earliest IND for CBD was filed in November 2007, the time when GW Pharmaceuticals announced a clinical trial of a drug containing CBD.

CannaVest is confident there is enough evidence to show CBD was marketed as a supplement ingredient first.

“It is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD,” says Stuart Tomc, vice president of human nutrition, CannaVest.

Tomc also questions the “substantial” nature of the drug investigations on CBD that did exist at the time—namely, stating that those investigations that were publicized were not substantial, were limited in number, and were preliminary in nature, “thereby rendering the IND preclusion inapplicable,” he says.

But even if there is proof that CBD-containing supplements were on the market prior to what FDA would consider the critical date in drug development, FDA might still dismiss the idea of an exception to the drug application because CBD did not have regulatory approval for supplements.

“I suppose FDA could come back, or the pharmaceutical company could come back and say, ‘Yes, but you were selling [CBD in supplements] illegally. You didn’t have regulatory status’,” says John R. Endres, ND, chief science officer for GRAS and NDI consultant AIBMR Life Sciences Inc. (Puyallup, WA).

Additionally, CannaVest’s Tomc thinks the conversation about CBD’s future is bigger than this issue of timing, and should also include a discussion of dietary supplements and drugs both using CBD legally.

“I think that an exception has to be made that we can coexist in the same space, because of the fact that government can’t and shouldn’t stop people from growing and creating their own medicine,” says Tomc. “If anyone hasn’t noticed, the do-it-yourself movement is in full swing.”

Will FDA Come Knocking?

If nutritional supplements are indeed boxed out of using CBD ingredients legally by the approval of this drug application, it’s still unclear how active FDA would be in enforcing against supplements that continue to include CBD. The May announcement from FDA is vague on these details, stating only that factors such as “agency resources and the threat to the public health” would be considered in deciding whether to take enforcement action.

Given the many CBD supplements already on shelves in health food stores and mainstream supermarkets across the country, it could be cumbersome to enforce against all CBD products currently on the market. HIA’s Steenstra expects CBD supplements would not be high on FDA’s list of priorities.

“They have limited resources, as with any federal agency, and they have to weigh what things are important and what aren’t,” says Steenstra. He adds, “I would like to continue to believe that FDA has more important things to do than to try to stop companies from marketing CBD as a dietary supplement when, not only is it not harming anybody, it’s actually quite helpful.”

One clue of what to expect might lie in the 1997 case of a red yeast rice supplement ingredient and the regulatory tension between supplement firm Pharmanex (Provo, UT) and pharmaceutical firm Merck (Kenilworth, NJ).

“The Pharmanex case provides some context for what could happen,” says AHPA’s McGuffin. “FDA acted against Pharmanex in 1997 for that company’s marketing of its red yeast rice dietary supplement product, Cholestin, which was manufactured to contain a controlled level of lovastatin. FDA had authorized Merck’s lovastatin drug (Mevicor) several years prior to the introduction of the Pharmanex product.”

McGuffin continues, “Although FDA acted forcefully to removed Cholestin, red yeast rice products standardized to lovastatin have continued to be available since the removal of this one brand. FDA issues occasional warning letters to marketers of these products, including at least two such letters in 2014.”

But even if FDA takes minimal enforcement actions against CBD supplements, the drug application could still have an impact on the market. In fact, it already has.

Trade Show Turns Away CBD Supplements

The first big ripple to come as a result of FDA’s statement on CBD may be the July announcement from New Hope Natural Media (Boulder, CO), organizer of the Natural Products Expo trade shows, that it will ban dietary supplements containing CBD from its show floors.

“The Expo standards department is requesting that exhibitors not display, sample, or promote CBD products packaged or labeled as dietary supplements, based on U.S. FDA’s May 13, 2015, statement that the agency considers CBD products to be excluded from the definition of ‘dietary supplements,’” said New Hope.

CBD-rich foods, cosmetics, and bulk CBD will still be allowed for display at the New Hope shows, however. Although CBD foods and CBD supplements may both lack official regulatory status, New Hope seems to be following FDA’s explicit mention of CBD supplements in making its decision to ban CBD supplements, but still allow foods.

“It kind of makes me wonder whether Expo does really want to support CBD, but feels like they can’t for that one thing that got knocked off the list because of what FDA said,” says AIBMR’s Endres.

CannaVest’s Tomc says he was surprised by the announcement from New Hope and disappointed to see CBD on the same list as the show’s other prohibited supplement ingredients, such as artificial sweeteners and artificial colors. However, he says he hasn’t seen any other signs of anxiety in the industry as a result of FDA’s statement on CBD. Actually, he’s seen the opposite.

“The more I tell people about this, the more they want to carry the product. It’s having the exact opposite of the intended effect,” says Tomc. He adds, “If anything, this has increased awareness and will continue to increase awareness of this ingredient that we’re being told can be controlled by a pharmaceutical company for one narrow indication.”

What’s Next?

The consensus seems to be that, justifiably or not, the approval of CBD as a drug ingredient would be detrimental to the prospects of CBD as a supplement ingredient. But what happens if the drug ingredient application fails, or FDA decides CBD was legally used in supplements before 2007? Well, there are still a few obstacles to legal acceptance.

Perhaps the most likely first step is to definitively reschedule CBD so it is no longer a Schedule 1 substance. Although some, such as HIA’s Steenstra, do not believe CBD is currently Schedule 1 anyway because it is not specifically mentioned in the Controlled Substances Act, it’s a step that may still be necessary to clear up any lingering taboo around industrial hemp. There are already bills being considered in the U.S. legislature that would decisively extricate CBD from the definition of marijuana.

A GRAS application would likely soon follow, and CannaVest’s Boucher says the industry is currently amassing the toxicology studies and other research necessary for GRAS review. And once that happens, CBD could really take off in foods and supplements.

“If it gets GRAS, I think that’s when you’re going to see it really take off. Then your big players in the field will start using it,” says Boucher. He adds, “The legal technicality is keeping some of these multibillion dollar corporations from entering it—the whole grocery chain, some of the big vitamin chain stores, the health food stores. Your big corporate chains are just on the sidelines, and I think it would open the doors to companies of that size to say ‘Okay, we’re jumping in.’”

But if FDA chooses to accept CBD as a drug ingredient and remains inflexible to CBD supplements, mass-market retailers may continue to stay on the sidelines when it comes to CBD supplements. Boucher says the move would certainly pose challenges, but that CannaVest will continue to look for ways to navigate the legal options and bring CBD supplements to the consumers.

“It will bring us into a different category,” says Boucher. “We’re working on different business models if that does happen. We’ll still be here. We’ll still be in the supply chain. We’ll just have to go in a different direction.”