William Garvin, shareholder at Buchanan Ingersoll & Rooney PC, was speaking to FoodNavigator-USA after the FDA warned 15 companies about “illegally selling products containing cannabidiol,” and noted that “failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.”
Aside from one prescription drug [Epidiolex] approved to treat two pediatric epilepsy disorders, said the agency, CBD products have “not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety, including reports of products containing contaminants, such as pesticides and heavy metals.
“There has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.”
In comments that immediately provoked pushback from CV Sciences, which has self-affirmed that its hemp extract is GRAS, the FDA added that it “cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
‘The current situation makes it difficult for companies to provide FDA with safety data’
Asked whether the FDA’s statement should concern brands that are currently selling CBD products without making any claims, Garvin said: “It increases the risk that FDA might take enforcement action against you.
“While it is true that FDA has been consistent on the illegality of CBD in foods and dietary supplements, FDA previously had greatly restrained its enforcement action in this space and today’s announcement is a departure from that enforcement position with much stronger language. This suggests a serious change in enforcement priorities for the agency.”
So what happens next? “I expect there will be a lot of pushback from consumers, companies, and politicians against FDA on this issue,” predicted Garvin, who expects to see “a lot more lobbying from companies and consumers that support CBD… to see if they can get Congress to support legislation to resolve these FDA issues.”
‘FDA simply wanted to re-emphasize what it’s been saying all along’
However, other legal experts we contacted played down the FDA’s announcement, with Brian P. Sylvester, special counsel at Foley & Lardner LLP, telling us the agency „simply wanted to re-emphasize what it’s been saying all along: Under current law, it is currently unlawful to add CBD to food or dietary supplements, and that FDA continues to have concerns around the safety of CBD.”
The warning letters all focused on firms making unsubstantiated disease claims, he observed. „I don’t think that practically speaking it changes FDA’s enforcement posture. But I think the FDA is increasingly concerned about the safety of CBD.”
But by saying CBD is not GRAS, is the FDA effectively closing off the GRAS affirmation pathway for CBD, as UNPA president Loren Israelsen suggested to our sister site NutraIngredients-USA?
„Not exactly,” said Sylvester. „FDA simply stated that it does not currently aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. It’s not inconceivable that, in the future, data could be brought to bear before the FDA to support GRAS status.”
‘FDA still keeps the letters aimed at the fringe companies’
Todd Harrison, partner at law firm Venable, in turn, said that the announcement was not the bombshell some commentators have suggested it is: “I do not attach any great significance as FDA still keeps the letters aimed at the fringe companies, although it will still continue to have a chilling effect on major outlets. With that said, FDA knows it will not get voluntary compliance based on these warning letters and in many ways shows the agency’s tenuous position.”
So does this change anything on a practical level? “It does not,” argued Harrison. “There is not anything new here but a simple recitation of the law that is required for all ingredients. Again instead of complaining, FDA is not being fair. Submit the safety data and take the agency to task on its questionable position of permissibility. Win the safety argument and the preclusion issue disappears.”
So what does he expect will happen next? “At some point, someone will submit [a GRAS determination or NDI notification to the agency] and I believe the agency will back down or face Congress’ wrath,” he predicted.
Why issue the letters now?
As to the timing of the announcement, Jonathan Havens and Lauren Farruggia noted in a blog post that given the uncertainty over how the yet-to-be-confirmed FDA commissioner Dr Stephen Hahn will approach CBD, „It is possible FDA pushed out this new round of enforcement and guidance ahead of Hahn joining the Agency as a way to preserve the FDA’s position.”
They also noted that in „a potential foreshadowing of expanded enforcement, the agency indicated that, in addition to continuing to pursue such products [making egregious and unsupported health claims], it will also monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants (pesticides, heavy metals, THC) and those marketed to vulnerable populations such as the elderly, children, adolescents, pregnant, and lactating women.”
„The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered.”
Steve Mister: ‘FDA’s inaction for the past year has facilitated an unregulated marketplace’
Steve Mister, president and CEO at the Council for Responsible Nutrition, said the FDA’s “headline-grabbing announcement” had “unnecessarily alarmed consumers,” arguing that the agency had not cracked down on irresponsible players but at the same time had failed to give responsible firms with safety data a clear route to market.
“FDA’s inaction for the past year has facilitated an unregulated marketplace—which is bad for consumers and bad for business. FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode.”
The FDA cites potential adverse effects from CBD, but does not distinguish between the high doses delivered in Epidiolex, and the low levels typically used in supplements, said Mister, noting that the “dose makes the poison.”
‘The agency has repeatedly said CBD must be treated like any other ingredient, but it has refused to do just that’
There are already mechanisms in place to regulate CBD like any other ingredient (NDI notifications, GRAS determinations), he added: “The agency has repeatedly said CBD must be treated like any other ingredient, but it has refused to do just that.
“FDA continues to call on industry to produce safety research for the public docket but to dismiss NDI notifications and GRAS declarations for CBD. It is not too late for FDA to do the right thing: it should explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products.”
If the FDA does not act soon, he argued, Congress should get involved to “direct the regulator to open the supplement lane to CBD and to police these products with the ample enforcement tools at its disposal.”
„This is a significant, concerted and highly orchestrated effort by FDA to put the brakes on the CBD market.”
Loren Israelsen, president, United Natural Products Alliance