Enforce Immediately In CBD Supplement Market, Industry Groups Suggest To FDA

FDA should go beyond warning letters to carry out inspections, import reviews and other actions on companies marketing CBD-containing supplements and foods, CHPA says. It and other consumer health trade groups urge agency to act immediately numerous businesses marketing products that could threaten public health.

Carefully plodding a pathway for lawful marketing of cannabidiol-containing dietary supplements and foods isn't enough from the US Food and Drug Administration, say industry trade groups. Enforcement should start immediately, they suggest.

“FDA must go beyond warning letters to inspections, import reviews and other enforcement actions. These would be important steps and utilize existing regulatory tools that do not require further legislative authority or rulemaking,” says the Consumer Healthcare Products Association.

CHPA and other trade groups, as well as consumers and other interested parties, submitted comments by the 16 July deadline to the FDA's request scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds. Separately, the FDA published another warning letter about CBD-containing products marketed as unapproved drugs and indicated in a statement that it is getting the message from supplement industry trade groups that enforcement over supplements, food, personal care and other non-drug products containing CBD or other hemp- or cannabis-derived ingredients cannot wait. (See sidebar articles.)

The agency also could issue more consumer alerts or “play a greater role in raising public awareness about claims that are simply unsupported by data,” stated David Spangler, CHPA’s general counsel and senior vice president for policy, in the comments.

Echoing similar sentiments by the Council for Responsible Nutrition and the Natural Products Association, CHPA suggests the agency’s current approach of discretionary enforcement isn't stringent enough, as the US market for CBD-containing products is exploding with new products and in sales anticipated to reach $500m by the end of 2021.

“With little regulatory oversight, the marketplace offers a vast array of products of varying degrees of quality, an array of unapproved drug claims and in some cases, fraudulent products,” Spangler added. For example, products sold to consumers claim to have certain levels of CBD when none of the ingredient may be used or it's present “at multiples above” the labeled amount. Some products labeled as containing CBD may actually be formulated with tetrahydrocannabinol (THC) also, or alone.

CRN: ‘Formalize Enforcement’

An immediate step-up in enforcement action is necessary to protect public health, Megan Olsen, CRN's assistant general counsel, and Andrew Shao, interim senior VP for scientific and regulatory affairs, state in the group's comments.

Companies with “significant experience” manufacturing supplements and food products, including many CRN members, “are reluctant to enter the market until the legal status of CBD in supplements is clarified,” Olsen and Shao wrote.

Without compliant and experienced firms in the space, a void is left for other businesses “that may not understand dietary supplement or food regulations – or may not care to follow these regulations,” resulting in the launch of “questionable and even dangerous products,” they state.

Drug Approval, Farm Bill, CBD Docket

The FDA opened a docket for comments – FDA-2019-N-1482 – and launched an initiative for considering regulatory pathways for lawful marketing of CBD-containing supplements and food for reasons including the exploding market of noncompliant hemp- and CBD-containing products that started after states in the mid-2000s began legalizing sales and use of medical marijuana followed later by allowing sales and possession of recreational amounts of cannabis.

Agency officials were aware of the hemp and CBD food and VMS product market well before the FDA opened a docket for looking at clearing those ingredients as eligible for use in non-drug products. It pointed to beginning the deliberations after approving the first drug available in the US made with a cannabis-based active ingredient in July 2018, when agency officials also explained that regulations prohibit using as a dietary ingredient or food additive any substance that is the subject of clinical drug studies or has been approved for use in a drug. (Also see "CBD Drug Approval Not A Sign FDA Will Allow Its Use In Supplements " - HBW Insight, 26 Jun, 2018.)

The process got its formal launch in December after Congress passed the 2018 farm bill. The latest five-year reauthorization of spending for US Department of Agriculture programs included a provision removing hemp – defined as cannabis plants and derivatives containing no more than 0.3% concentration, on a dry weight basis, of tetrahydrocannabinol, the psychoactive ingredient in cannabis – from the Drug Enforcement Administration's schedule of controlled substances. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)

Indications are those sorts of products are already flooding the market. Olsen and Shao point to warning letters FDA sent to three firms in March about claims for CBD treating diseases and conditions including cancer. (Also see "FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps" - HBW Insight, 2 Apr, 2019.)

CRN president and CEO Steve Mister made a similar point during FDA’s May 31 public hearing to discuss possible pathways for lawful marketing of CBD-containing supplement and food products. He said most companies entering the CBD supplement space have not marketed any supplements before and are likely not up to speed on regulatory requirements. (Also see "VMS Industry Wants Into CBD Market, Plus Enforcement On Firms Already There" - HBW Insight, 4 Jun, 2019.)

The agency does not prevent marketing of hemp- or CBD-containing supplements that are compliant with supplement labeling and manufacturing requirements, particularly if the formulas are not labeled or promoted with drug claims. However, the practice is a deviation from FDA regulations which prohibit using in supplement ingredients contained in approved drug products or that are being studied in pharmaceutical tests; CBD is an active ingredient in an FDA-approved drug and it and THC are subjects of clinical investigations.

CRN takes its enforcement suggestion a step further in urging the agency to formalize the process.

The agency’s current policy is confusing to consumers because it does not take action unless a marketer is making a drug claim, which already is prohibited for supplements, Olsen and Shao say. The agency, they argue, is “potentially signaling to consumers that CBD products on the market are safe and acceptable at their current levels and forms.”

Formalizing the discretion policy could clear up the confusion, they say.

“Such a step would be coupled with strong guidance and agency action that products being marketed as dietary supplements will be treated as dietary supplements,” they added. “These products should, for example, be manufactured in FDA registered facilities, following good manufacturing practice requirements; the products should bear compliant labels; and manufacturers should properly record and report adverse events, among following the other FDA regulations necessary to ensure safety."

NPA: ‘Stabilize the Market'

In its comments, the Natural Products Association says more inspections of firms making CBD-containing supplements and foods “should be a top priority” as inspections currently are “in no way adequate.”

President and CEO Dan Fabricant stated in NPA's comments that the association had filed a Freedom of Information Act request on records involving manufacturers of CBD and FDA’s issuance of form 483s listing violations found during facility inspections.

NPA discovered that among hundreds of firms in the US marketing roughly 1,500 CBD-containing products, four have been inspected by the FDA; of those four, three received a form 483 identifying manufacturing or labeling problems found when they were inspected.

“More troubling is in that FOIA we also asked for information on samples taken and how many were tested for [THC]. There were only 29 testing entries, three of which mentioned THC, however, they appeared partially redacted, so the disposition of such sampling is unknown to us,” Fabricant said.

“These numbers do not send a message of a willingness to engage on enforcement regarding CBD products and especially those that could [possibly] contain levels of THC, which is still a schedule 1 substance,” he added.

Fabricant suggested that FDA’s consideration of allowing marketing of CBD does not preclude it from enforcement currently. “In the interim, rulemaking does not prohibit the agency from stabilizing the marketplace now while adding real regulatory oversight and effort,” he said.

In March comments submitted on FDA’s request for input in preparation for an upcoming United Nations meeting on drug policy, Fabricant stated concern over what appears to be an absence of establishing a deterrent in selling supplements and foods with CBD. Firms may weigh “the regulatory risk of receiving a warning letter vs. the potential profitability and gains realized in sales of CBD products across states lines,” he said. (Also see "CBD Market 'Surges' As FDA Delays Setting Regulatory Policy – NPA" - HBW Insight, 21 Mar, 2019.)

The three industry groups also provided FDA with suggestions on a rulemaking for CBD-containing foods and supplements.

At the May public hearing on regulating the CBD space, NOW Health Group executive Aaron Secrist said policy changes making hemp and CBE eligible for use as dietary ingredients should include requiring regulatory compliance by companies already marketing products. (Also see "FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps" - HBW Insight, 2 Apr, 2019.)

In June, Sen. Ron Wyden D-OR told FDA its typical two- to three-year period for a rulemaking would be “fully unacceptable” for a regulation on CBD in non-drug products. He asked the agency to accelerate its rulemaking process and publish an interim final rule that allows manufacturing and sales of hemp-derived CBD food and supplements under the FDA’s existing rules. (Also see "Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access" - HBW Insight, 26 Jun, 2019.)