CV Sciences Inc. revealed this month that its “hemp-derived CBD gold extract” has met rigorous “FDA safety guidelines”: It received self-affirmed GRAS (generally recognized as safe) status, a designation that under the law applies to substances added to food.
The gold extract includes CV Sciences’ PlusCBD Oil Gold Formula product line.
Stuart Tomc, vice president of human nutrition with CV Sciences, concluded in an email that his employer’s “historic GRAS work demonstrates the safety of our ingredient and represents incremental progress in the regulatory evolution of hemp in America.”
Though its self-affirmed GRAS status marks an achievement for the company, FDA could disagree with the assessment and still doesn’t consider cannabidiol (CBD) a lawful ingredient in either a food or dietary supplement, several sources outside the company said.
But CV Sciences’ investment paved the way for it to expand its product portfolio. The public company (OTCQB: CVSI) recently ventured into the food business through a collaboration with SNAAK BAR. In August, the company announced the nationwide launch of a CBD sports bar product line, SNAAC CBD.
The launch marked CV Sciences' debut in the food space.
The hemp-based CBD sports bar, CV Sciences said in a press release, is “designed to improve athletic and workout performance through advanced phytocannabinoid nutrition.”
And last week at Natural Products Expo East in Baltimore, CV Sciences debuted its PlusCBD Oil Gummies. The gummies incorporate the gold formula and include 5 mg of CBD per serving.
CV Sciences has been among the pioneers in bringing CBD to mainstream America and furthering the national conversation over the distinctions between hemp and marijuana. The company introduced its PlusCBD Oil as a dietary supplement in 2014, and it’s now distributed through nearly 2,000 natural products retailers across the United States.
“We are committed to building consumer confidence and trust in the safety and quality of our products, supported by scientific evidence,” Joseph Dowling, chief executive officer of CV Sciences, said in a statement. “This milestone significantly advances our leadership in this space and provides us with opportunities to broaden consumer access to our products, while removing any doubts on the safety and benefits of our products.”
Some sources lauded CV Sciences’ investment in science. But several lawyers said it does not resolve myriad regulatory barriers facing marketers of CBD in conventional foods and supplements.
“We believe there are legal hurdles and you have to address them sequentially,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), which represents dietary supplement and functional food manufacturers, ingredient suppliers and companies providing services to those entities. “You can’t get to the second and third hurdle until you knock down the first one.”
The first hurdle, Mister noted, is the Drug Enforcement Administration (DEA). DEA has asserted CBD—depending on where the compound is sourced from the cannabis plant—is a Schedule I controlled substance.
Language passed by the U.S. Senate would legalize hemp as an agricultural commodity, removing it from the federal list of controlled substances. Even if the language is passed by Congress in the coming weeks as part of a comprehensive 2018 farm bill, legal experts said it would not remove a distinct obstacle: FDA.
FDA has asserted CBD can’t be sold in foods or supplements. Its reasoning is tied to clinical investigations instituted by GW Pharmaceuticals plc, which obtained FDA approval in June to market Epidiolex, a CBD drug to treat seizures associated with certain forms of epilepsy.
Mister of CRN commended CV Sciences for developing the science and obtaining an independent GRAS conclusion. He nonetheless said the work still didn’t address the fundamental issue of whether CBD is a lawful ingredient in a food or dietary supplement.
Justin Prochnow is an attorney in Denver who advises supplement, food and beverage companies on FDA regulations. He described CV Sciences’ announcement as “good news for the industry,” though he noted FDA isn’t required to accept the conclusions of a self-affirmed GRAS report.
“Self-affirmed GRAS status also doesn’t change the fact that the FDA still considers CBD to be a nonpermissible ingredient due to the investigation of a new drug,” Prochnow, a partner with Greenberg Traurig LLP, wrote in an email. “However, if the ingredient investigated by GW Pharma is sufficiently distinguished, it does pave the way for strong arguments about its use in foods and beverages.”
Todd Harrison, a partner in Washington with Venable LLP, reiterated the observations of many of his colleagues in the legal profession.
“Is there a lawful basis to market it—a standardized CBD product—in light of GW Pharma?” the regulatory lawyer asked. “It could be the safest ingredient in the whole world. It doesn’t matter.”
George Burdock, Ph.D., is president of Burdock Group, a safety and regulatory consulting firm in Orlando, Florida. He declined to discuss the safety of CBD as an ingredient in a food or supplement because he considered it “moot” given FDA’s position that the compound can’t be sold in either product category.
“While it is possible that use of CBD may be added to foods or supplements in some states,” Burdock asserted it would be prohibited in interstate commerce.
“It is especially ironic that someone would try to GRAS a substance, using a federal statute, the Food Drug and Cosmetic Act, when that same federal government has held since at least the 1920s, that marijuana (including CBD) is an illicit drug and, in 1970 reclassified it as a Schedule I drug,” he said in an email for this article. “All the wishing, hoping and handwringing is not going to make CBD a legitimate candidate for addition to food or supplements until the law is changed.”
Marketers of CBD and hemp extracts have expressed a different opinion than FDA, whose position on CBD has neither been the subject of a court case nor been made formal through a rulemaking proceeding or even issuance of a guidance document.
Expressing a view that he said is “broadly shared by the marketplace,” Tomc said hemp-derived CBD was marketed before any “substantial clinical investigations” began and were publicized.
“The investigations that were publicized were not substantial, due to being limited in number and preliminary in nature, thereby rendering the IND [investigational new drug] preclusion inapplicable,” he added. “Furthermore, the IND preclusion isn’t a new conversation in the dietary supplement industry. Many ingredients such as trans-resveratrol, P5P [pyridoxal-5-phosphate] and DHEA [dehydroepiandrosterone] have been subject to the same scrutiny and continue to be sold as dietary supplements.”
Notice to FDA
In response to questions for this article, Corinne Newhart, an FDA spokeswoman, said her agency “has neither received nor reviewed any GRAS notices for the use of CBD oil in foods.”
She also referenced an FDA Q&A on marijuana, which outlined the agency’s position regarding CBD in foods and supplements.
In the Q&A, “[W]e have concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added,” Newhart said in an emailed statement. “We have also concluded that CBD products are excluded from the dietary supplement definition, and therefore cannot be properly classified as dietary supplements.”
In 2016, FDA published a final rule describing the criteria for concluding the use of a substance is GRAS. In a constituent update published at the time, FDA encouraged “companies to inform the agency of GRAS conclusions through the notification procedure” in the final rule. But CV Sciences was under no obligation to notify FDA of the independent GRAS conclusion.
“While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts,” FDA stated in the constituent update.
Daniel Fabricant, Ph.D., formerly led FDA’s Division of Dietary Supplement Programs. He questioned why CV Sciences didn’t approach FDA first with its GRAS plans. (CV Sciences didn’t immediately comment when asked about the issue). Companies often meet with FDA first before preparing a GRAS notice or other paperwork related to agency regulations and guidelines.
“Why wouldn’t you go through the front door with the agency?” asked Fabricant, the president and CEO of the Natural Products Association (NPA), a trade organization founded in 1936 representing retailers and manufacturers in the natural products industry. “If the agency tells you flat out, ‘Hey, we’re really not going to look at it,’ [and] you have really good science, … then you publish it … We get that.”
In recent years, though, FDA did not assess whether companies met the relevant safety standard in the Dietary Supplement Health and Education Act of 1994 (DSHEA) in the few instances in which it received new dietary ingredient notifications (NDINs) for the use of CBD in a supplement.
Responding in a 2017 letter to an NDIN filed by a company called “HoneyColony” for its “Superior Hemp Oil,” an FDA official, Robert Durkin, explained FDA concluded CBD products are excluded from the definition of a dietary supplement.
“This is because CBD has been authorized for investigations as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,” Durkin wrote. “Prior to such authorization, it was not marketed as a dietary supplement or as a food.”
Due to its conclusion above, FDA didn’t respond to whether the notification was complete or showed an adequate basis of safety.
Several sources with expertise in regulatory matters suggested the two NDINs submitted were very rudimentary submissions that the agency would have objected to—had FDA reviewed the safety information and sufficiency of the filings under its regulations.
Elizabeth Moriarty is a formulator and custom manufacturer of HoneyColony’s Superior Hemp Oil. In an email, she described HoneyColony’s NDIN, which was submitted by a former HoneyColony employee, as “a rather stunning choice … based upon a profound lack of awareness combined with youthful enthusiasm.”
“Neither HoneyColony nor my company, Luminary Medicine Company, are financially or logistically prepared to challenge the FDA position that CBD and/or THC are ineligible for supplement status,” she wrote.
Safety work: Consideration for HHS?
Lawyers have said the controversy over the legality of CBD could lead to years of litigation, casting a cloud over the compound’s future in foods and supplements. However, there are other possible outcomes—including one that CV Sciences’ GRAS work could influence.
Under DSHEA, the secretary of the U.S. Department of Health and Human Services (HHS) has authority to make CBD lawful in a dietary supplement through a rulemaking following notice and comment. FDA is an agency within HHS.
The safety of CBD would need to be demonstrated before the government would “engage in a notice and comment rulemaking in the first place,” said Steven Shapiro, of counsel to Rivkin Radler LLP in New York, who advises companies on the nuances of DSHEA. The independent GRAS conclusion announced by CV Sciences, the lawyer added, “would certainly be a factor in convincing FDA that it should allow CBD in dietary supplements and foods.”