HBW Insight: Health, Beauty and Wellness
By Tom Gallen 14 Feb 2020
Italy's Menarini is expanding its portfolio in Spain with the launches of three new supplements and a couple of oral...
Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.
The clock could be ticking on using cannabidiols in dietary supplements available in the US without submitting new dietary ingredient notifications that the Food and Drug Administration agrees show safety for the ingredient's intended uses.
The agency's recent statement that it is not aware of evidence supporting CBD as generally recognized as safe among qualified experts for use in human or animal food potentially points to NDI notifications as the only option that manufacturers, marketers and other businesses will have to convince the FDA about reasonable expectations of safety for CBD and other hemp-derived substances used in dietary supplements.
"As a dietary supplement company, I would be very nervous about relying on GRAS to justify using CBD in my products," said Laura MacCleery, policy director at the Center for Science in the Public Interest.
CSPI POLICY DIRECTOR LAURA MACCLEERY: "AS A DIETARY SUPPLEMENT COMPANY, I WOULD BE VERY NERVOUS ABOUT RELYING ON GRAS TO JUSTIFY USING CBD IN MY PRODUCTS."
In addition to showing safety for a food ingredient, the GRAS process historically has been used to justify ingredients' use in supplements when a substance might not be acknowledged by the FDA as a dietary ingredient but its use in food is recognized.
The GRAS process isn't an easier lift, though. That's because although GRAS affirmations need not be submitted to the FDA, the underlying safety data in a GRAS dossier must be peer-reviewed and published, which adds significant costs and time and which is unlike NDI notifications, which can rely on in-house data.
MacCleery noted in an interview that FDA already has deemed CBD, and other hemp- or cannabis-derived ingredients, as unlawful for use in food and supplements because CBD from cannabis was studied in clinical drug trials and is approved for use in a drug and because no NDI notifications have been submitted asking the agency accept any cannabidiols as safe for their intended use sand allow an exception to the exclusion rule.
With its 25 November announcements, she said, the FDA is making clear that GRAS status won't work for using CBDs in food and supplement products. "The thing that's new is if you are a company that was relying on self-confirmed GRAS as a basis for using CBD in your products, that door is closed now," she said.
However, even though the FDA stated a dim view for GRAS to support using CBD in supplements, food and drug law attorney William Garvin says the agency didn't say it wouldn't consider additional evidence. The agency's announcements, including an updated consumer alert along with a statement accompanying its publication of warning letters to 15 firms making violative claims that renderd their CBD-containing food, supplement and animal care products as unapproved new drugs, signal its concern about CBD safety, Garvin told HBW Insight.
"I see this as FDA’s current stance on the issue but they may be open to other data to show that it is GRAS. I think FDA is very concerned about safety issues and they want to make sure that industry provides some data to justify use of CBD at certain levels for non-diseased consumers in foods and dietary supplements," he said.
The agency continues considering potential pathways for lawful use of cannabidiols in non-drug products – docket FDA-2019-N-1482 – as it allows sales of supplements, food and cosmetic products containing the ingredients without drug or other violative claims and otherwise compliant with relevant regulations. The FDA continues accepting comments on questions it posed about using hemp- and cannabis-derived ingredients in products other than drugs months after the comment period closed because it received little data on CBD safety and on related questions it posed in the docket. (Also see "FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks" - HBW Insight, 20 Nov, 2019.)
Meanwhile, for food products, the food additive petition process could be the only path to convince the FDA of CBD's safety. Agency regulations state that a substance that is not GRAS for its intended use in food and does not qualify for any exemptions from the food additive definition, it is a food additive.
More Work Before Progress Report
While the FDA leaves no doubt about its CBD concerns, what happens next isn't so clear, Garvin said. Publishing 15 warning letters at once along with making a strong statement against GRAS for CBD likely will get attention from lawmakers as well as in the industry and marketplace.
ATTORNEY WILLIAM GARVIN: "FDA WILL WAIT TO SEE WHAT TYPE OF POLITICAL PUSHBACK THEY GET."
"I think what will happen next is that FDA will wait to see what type of political pushback they get. If they don’t get any, I think they will continue to remove products from the market because they think these products are unsafe. If they get enough pushback, they may announce enforcement discretion or announce a regulatory pathway or suggest a congressional fix," Garvin said.
Another option the FDA could follow would be a sign of how state laws on cannabis and hemp are influencing the food and supplement industry's choices. The agency could "exercise enforcement discretion in states that have CBD-related legislation that legalizes the products in those jurisdictions (like they do with marijuana) as long as the companies make clear they only sell the product in certain jurisdictions," he said. "But it is all up in the air right now."
In HBW Insight's earlier coverage, food and drug law attorney Rend Al-Mondhiry, senior counsel at Amin Talati Wasserman LLP, also said the FDA hasn't conclusively written off GRAS for CBD and doesn't appear close to deciding on potential pathways for lawful use of cannabidiols. (Also see "FDA Warns 15 CBD Product Marketers For Violations, Cautions Consumers: CBD May Harm You" - HBW Insight, 27 Nov, 2019.)
"FDA could be trying to make it difficult for companies that are doing self-GRAS work, since expert panel members may be somewhat hesitant when they see this strongly worded statement form FDA,” said Al-Mondhiry, who previously was legal counsel at the Council for Responsible Nutrition.
And the FDA acknowledged in its statement that it hasn't ended its consideration of cannabidiols' regulatory pathways. The agency's process "includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards."
An update on the process that agency officials pledged by the end of the year is still to come. (Also see "With Another Warning, FDA Pledges Report On CBD Use In Non-drug Products" - HBW Insight, 23 Jul, 2019.)
"The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks," it said.
A progress report, though, could be the first step in a much longer process. A notice-and-comment rulemaking by the FDA could be necessary not only to make lawful the use of hemp- or cannabis-derived ingredients in non-drug products, but to require NDI notifications for the substances' use in supplements.
"I believe that FDA’s current position is that both a regulation permitting CBD in supplements as well as an NDIs for CBD would be necessary for CBD to be in dietary supplements," Garvin said.
However, FDA rulemakings typically extend for multiple years and agency officials, as well as industry stakeholders have said that Congress could expedite the changes through legislation. (Also see "CBD Public Hearing Could Extend FDA's Hand Further For Help From Congress" - HBW Insight, 29 May, 2019.)
Should the FDA require NDI notifications for using CBDs as dietary ingredients, the move would have support from industry trade groups and from vitamin, mineral and supplement product firms that have not entered the CBD product market in order to remain fully compliant with the agency's regulations. RS148877
Compliant firms suggest requiring NDI notifications for all CBD dietary ingredients, including those already used in products available in the US, and potentially imposing financial penalties against firms that have been marketing CBD supplement even though the substance is unlawful for the use.
HBW Insight: Health, Beauty and Wellness
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HBW Insight: Health, Beauty and Wellness
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In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a...
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