The most recent submission comes from a group called the National Industrial Hemp Council (NIHC). The group submitted an outline for proposed hemp regulations to FDA yesterday, according to a press statement.
“NIHC members support safety standards for our industry. We are well aware of the reports of inconsistent products that do not contain the ingredients listed on the label, those that feature unsubstantiated health claims, or which contain excessive THC levels or other contaminants,” said Patrick Atagi, chairman of the NIHC board, in a letter to FDA.
NIHC: Existing studies support ingredients’ safety
NIHC is advocating for an official policy of enforcement discretion with the ultimate goal of getting regulatory resolution on the following points:
- A recognition that existing studies support the safety of human consumption of CBD in dosing appropriate for dietary supplements and conventional foods.
- FDA should continue to allow marketing and sale of CBD cosmetics while it investigates CBD consumption’s systemic impact on humans
- Clarity regarding standardized testing requirements and laboratory practice.
- Standardized national manufacturing and labeling requirements for product transparency.
- Definitions for key terms such as “broad spectrum,” “hemp extract,” etc.
The NIHC submission notes that the current patchwork quilt of regulations for CBD has made compliance extremely difficult on a national scale. In particular, testing requirements vary from state to state, making it all bu t impossible to make a blanket statement about the character of products on the market. NIHC is advocating for looking at existing regulations in Florida and proposed regulations in Colorado as a roadmap for what a sensible federally mandated testing regime ought to look like.
Vote Hemp: Unregulated products are the true safety concern
Another group that has been pushing for federal regulations of the hemp space is Vote Hemp, one of the oldest organizations in the sector that began advocating more than 20 years ago for the legal return of hemp farming in the United States.
Eric Steenstra, co founder and president of the organization, said it has been an uphill battle to get FDA engagement on the topic.
“FDA hasn’t been very receptive to our input,” Steenstra told NutraIngredients-USA. “They seem to have this bunker mentality.”
Steenstra said one of the more striking aspects of the current situation is that in his view the Agency is focused on details like the threat of liver toxicity at very high dosages, while there are thousands of products on the market that being sold in an unregulated state. Steenstra said his organization’s position is that getting control of those ought to be the Agency’s first order of business.
“The shocking thing for me is that I always thought FDA was there to look out for the best interests of consumers and to make sure that the products they were using were safe. They are focusing on things like liver toxicity, or possible drug interactions, when the real issue is unregulated hemp products on the market,” Steenstra said.
“I went to get a haircut the other day and my barber has a counter display of CBD products. This stuff is for sale everywhere. What is FDA doing at the moment to ensure that these products would meet the requirements of any other dietary supplement?” he asked.
Vote Hemp provided input the Office of Management and Budget more than a week ago that made the case for federal regulation of hemp/CBD products. The organization maintains that existing dietary supplement regulations, FSMA provisions, and facility registration requirements could be fairly easily be applied immediately to hemp/CBD products to ensure that consumers are better protected than they are now.
Despite regulatory impediments, sector is growing strongly
In its OMB presentation Vote Hemp noted that even with the market distortions and uncertainties that the regulatory impediments have imposed, hemp farming has been exploding in the US. According to the group’s figures, there were about 26,000 acres of hemp under cultivation in 2017. That rose to more than 290,000 acres in 2019, with more than 466,000 acres licensed for cultivation this year.
And consumer awareness is moving in lockstep with those figures, the organization maintains. The group’s figures show that 90% of Americans are aware of CBD and 26% have used the products. The group also said consumers seem to like the products, with a Consumer Reports survey finding that almost 75% of consumers said CBD was at least moderately effective for the reason they took it, while 48% said it was very or extremely effective.
Steenstra said even with the growth of market, a federal regulatory solution would provide an additional huge boost and provide some economic good news at a time when the country sorely needs it.
“Farmers are ready to contribute to our nation’s economic recovery. Let them,” the presentation said.
Upcoming CBD event
The American Herbal Products Association has had a Cannabis Committee for more than 10 years and was the first group in the supplement space to start cooperating with Vote Hemp, Steenstra said. AHPA is hosting its annual Hemp-CBD Supplement Congress in virtual fashion on August 27, which will give interested companies the latest information on regulatory and compliance questions, updates on the latest research and more. For more information, visit the event’s website.
