The impending bill (click HERE to read the conference report) asserts a ‘whole plant’ definition of hemp, defined as including all parts of the Cannabis sativa L plant, including “extracts” and “cannabinoids” with a THC concentration of <0.3%.
Provisions of the bill (p540) also amend the definition of 'marihuana' in Schedule 1 of the Controlled Substances Act, thereby removing hemp and all parts of the plant and all derivatives from that definition, effectively removing Drug Enforcement Agency (DEA) authority regarding hemp cultivation, production, or commercial activity for products that contain hemp or constituents of hemp, notes the American Herbal Products Association.
But this doesn’t have any bearing on the FDA’s position that CBD is not a permissible ingredient in a food, beverage or supplement because it was the subject of an Investigational New Drug (IND) application (by GW Pharmaceuticals, which markets the approved CBD drug Epidiolex for the treatment of seizures associated with two rare forms of epilepsy) and was not marketed in foods prior to that application, said Justin Prochnow, an attorney at Greenberg Traurig.
He told FoodNavigator-USA this morning: “I see all these emails going around saying once the Farm Bill passes, CBD is legal in all 50 states – and that’s just not true.” (Click HERE to read more on this.)
‘The 2018 Farm Bill has no effect on the FDA’s position that CBD is impermissible as an ingredient’
He continued: “I am constantly correcting that notion. The 2018 Farm Bill takes away the threat of DEA against companies for selling a product potentially identified as a Schedule 1 Controlled substance. But the 2018 Farm Bill has no effect on the FDA’s position that CBD is impermissible as an ingredient due to having been investigated as a new drug."
Is CBD generally recognized as safe (GRAS)?
Prochnow added: “It also doesn’t change the fact that neither CBD nor hemp extract are GRAS [generally recognized as safe] by regulation, meaning even if you get past the hurdle of the IND [investigational new drug] situation, a company would need to establish their CBD or hemp extract as GRAS, either by using a form that has been self-GRASed, and to date, only one company has done so** or by having their own GRAS report commissioned.
“So technically this [Farm Bill] doesn’t change the FDA’s position, but practically we’ll probably see the floodgates open and see more products hit the market because the FDA hasn’t shown much inclination to do anything about it. Other than sending out warning letters, they haven’t done anything else and have kind of indicated that unless you’re making crazy disease claims they are probably not chomping at the bit to do anything about it.” (The FDA has sent out warning letters over CBD, but it hasn’t gone further and sought injunctions to seize CBD products (yet) noted Prochnow.)
He added: “The problem is there’s no law or regulation from the FDA on CBD, there’s just the FDA’s opinion that it’s impermissible as an ingredient due to having been investigated as a new drug. But there’s a lot of potential pushback, you know, 'It was a 98% isolate and I’m selling a 40% isolate, so it’s not the same ingredient,' or 'I’m selling a full spectrum hemp extract,' and so on, but aside from that, it is not GRAS.
“But in the 14+ years I’ve been in this business, I’ve never had the FDA come to a client of mine and say, ‘We see that you’re selling ingredient X in this product, and we’d like to see the GRAS substantiation.'”
NPA: ‘This doesn’t affect the FDA’s oversight in any manner’
Dan Fabricant, PhD, president and CEO at the Natural Products Association, echoed Prochnow's comments, adding: “This doesn’t affect the FDA’s oversight in any manner, or remove the race to market provision which indicates that GW Pharma’s CBD drug was an IND prior to CBD being lawfully marketed.”
Attorney: ‘Something needs to be worked out with FDA’
Todd Harrison, an attorney at Venable who has also been trying to help clients navigate the CBD minefield, told FoodNavigator-USA that the 2018 Farm Bill “makes it clear that nothing herein usurps the authority of the FDA to regulate hemp in accordance with the laws.”
He added: “Also, there are many provisions that people are clearly not paying attention to such as not only will farmers have to get a license from the state or absent a system in place, the government so will manufacturers of hemp products because of the broad definition of hemp. Moreover, they will need to come up with a viable plan to destroy any THC that is made during the extraction process if it is a pure extract that is being produced. Manufacturers will also need to test for THC content in the final product.
“I believe it would be at least six months to a year before all the necessary regulations are in place at the federal and state level.”
Ideally, the industry could try and get the FDA to pass a special resolution that says even though CBD was investigated as an IND, it would allow it as an ingredient, he said: “Ultimately, something needs to be worked out with FDA instead of burying their head in the sand because primary jurisdiction is now at FDA not DEA once it is signed into law.”
FDA: We don't comment on pending legislation
Asked by FoodNavigator-USA this morning whether the Farm Bill has any bearing on the regulatory status of CBD in foods, beverages and dietary supplements, an FDA spokesman said it "does not comment on proposed or pending legislation," but referred us to a Q&A on its website highlighting that CBD is impermissible as an ingredient due to having been investigated as a new drug.
What is USDA responsible for and what is FDA responsible for?
To manufacturers confused about jurisdiction, Harrison said: "All facilities that are manufacturing hemp products will be subject to USDA’s regulations governing the cultivation, growing, processing, and manufacturing of hemp products. The states will have to submit their plans for approval to USDA."
But he added: "FDA will retain regulatory authority over food, dietary supplements, and cosmetic products that contain hemp and hemp derived products. FDA will not have any authority in regards to licensing facilities. Likewise, USDA will have no regulatory authority whether a particular ingredient may be added to an FDA regulated product."
What does the Farm Bill say about industrial hemp?
The final 2018 farm bill language has been released along with a Joint Explanatory Statement from the conference committee explaining which portions of the House and Senate versions of the bill were included.
The bill amends the Agricultural Marketing Act of 1946 with permanent amendments that categorize hemp as an agricultural commodity under the regulatory purview of the USDA, which means it should be eligible for federal programs such as crop insurance, agricultural research grants, and certification of organic production practices under the National Organic Program.
Other hemp provisions in the bill create requirements for hemp plans administered by individual states or tribal governments such that hemp production is under individual state or tribal controls. Over a one-year transition period, hemp plans (consisting of a record of properties where hemp is grown and various controls to verify the crop is hemp) will be submitted to the USDA.
What are companies marketing CBD for in foods and beverages?
But why are food and beverage companies using CBD in the first place (given that foods and beverages are not drugs, and many of the alleged benefits around CBD are around things like pain management, epilepsy and other indications that stray into the medical arena)? And is there any health benefit to consuming small quantities of CBD in foods and beverages?
Right now, said Prochnow, companies could technically make structure/function type claims about managing mild anxiety or pain or inflammation from exercise, which could be phrased in such a way that they are not unauthorized disease claims. But he added: "The problem is, what is your substantiation for these claims? Most companies right now are just saying how much CBD is in their products and that's it.
"I know of at least one plaintiff's law firm that is in this space a lot, that has specifically started targeting CBD companies, basically over lack of substantiation over claims."
*The Senate approved the $867bn farm bill by an 87-to-13 vote Tuesday afternoon (Dec 11). The legislation is now headed to the House, where it is also expected to pass.
** CV Sciences recently issued a press release announcing the self-determined GRAS status of its hemp-derived CBD gold extract. It has not responded to questions from FoodNavigator-USA asking if it plans to submit its GRAS determination to the FDA in order to try and secure a ‘no questions/objections’ letter.
