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No Great Expectations: The FDA’s Public Hearing on CBD Which Will be Held on May 31st

 

The Food and Drug Administration (FDA) will hold a public meeting on CBD policy for stakeholders on Friday, May 31st.

 

In December, when the Agricultural Improvement Act, commonly referred to as the 2018 Farm Bill, was signed into law, there was a general sense of exuberance in America’s hemp and CBD industries. But, as the saying goes, the “devil is in the details.” To some, the Farm Bill created more issues than it solved.  

 

The Farm Bill, removed hemp and derivatives of the hemp plant, including CBD, from the Controlled Substances Act. It allowed for the production and sale of hemp on an interstate basis, for any use, including both the production of flower and CBD.

 

The Farm Bill’s provisions regarding CBD were initially generally misinterpreted throughout the hemp and CBD industries. Especially for the CBD industry, the Farm Bill seemed to provide all participants in the industry with a “green light” to move forward, full-steam ahead.

 

This led to an attempt by the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to provide clearer guidance.  

 

The USDA indicated that it intended to regulate the growing of hemp and the FDA indicated that it would oversee any products that contain hemp or CBD that are sold as topicals, drugs, dietary supplements or as food additives. One item of confusion regards interstate commerce, which was allowed for by the Farm Bill. Individual states were delegated with the authority to refuse to allow sales of hemp or CBD products in their state.

 

Because of the media attention regarding the benefits of CBD and the passage of the Farm Bill, the FDA was forced to get involved. In the past, the FDA has refrained from regulating marijuana products produced under state-legal regulatory regimes and generally avoided regulating CBD-derived products produced from hemp, despite not having only the authority to do so, but technically the requirement to do so.

 

For the FDA, regulating marijuana or CBD was something that the agency wanted to avoid.Immediately after the signing of the 2018 Farm Bill, the FDA Commissioner at the time, Scott Gottlieb, published an update on hemp and CBD regulations, restating existing policies, but reminding the public that the Farm Bill did not necessarily change the FDA’s authority to regulate products with cannabis and its derivative.

 

The FDA update indicated that due to the increased public interest in cannabis, the agency needed to quickly clarify its regulations. The FDA update indicated that CBD was not “Generally Regarded as Safe” (GRAS) as a food additive and that CBD was not approved as a health, wellness nor nutritional supplement. What led the FDA to take this position is that prior to the Farm Bill being signed into law, CBD was illegal and no CBD producer nor marketer had gone through the process of seeking to have CBD approved as a food supplement to be GRAS, “Generally Regarded as Safe.” Likewise, no CBD producer nor marketer had sought FDA approval for CBD to be sold as a health, wellness or nutritional

supplement.

 

One other complication is that under FDA regulations, CBD is an “Active Pharmaceutical Ingredient” or API in an approved drug, GW Pharmaceutical’s Epidiolex. Epidiolex was approved by the FDA last year as a drug to treat forms of childhood epilepsy. The FDA’s position is that CBD can not be added to food or health, wellness nor nutritional supplements because of the Drug Exclusion Rule. The Agency’s regulations do not allow APIs proceeding with clinical trials, nor approved as drugs to be used in food or dietary supplements unless they were marketed as such prior to public investigations into that drug. Because Epidiolex was approved as a drug these regulations mandate that CBD can not be used as a food supplement nor for health, wellness nor nutritional purposes.

 

Cosmetic products are also a subject of confusion. The FDA indicates that “Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.” The FDA considers cosmetics adulterated if they contain “any poisonous or deleterious substance” which could harm users.

 

In other words, just because an ingredient is not prohibited as a cosmetic additive, doesn’t doesn’t mean it’s safe for its intended use. This is true for all cosmetics, including those containing CBD. The bottom line, CBD cosmetic products are currently a grey area as long as medical or health claims are not made.  

 

Today, CBD remains subject to the FDA framework that’s in place, but the FDA is working on providing potential pathways for products that contain CBD. The FDA also continues to monitor CBD products that claim therapeutic or medical benefits, similar to other non-CBD health, wellness or nutritional products.

 

The safe harbor that most major CBD marketers are taking is to avoid making any medical or health claims, until a new FDA framework is in place.  Also, small and large producers and marketers of CBD, including national retail chains are simply ignoring all the FDA issues. The general conclusion is that because of all the media attention to CBD, the popular support as well as support from both sides of the aisle in Congress, that the FDA will leave the CBD market alone until such time as the FDA adjusts its regulations to allow this new market. The one exception is the FDA will continue to go after marketers that are making medical or health claims.  

 

What Can We Expect to Result from the FDA’s Public Hearing?

 

Scott Gottlieb, the Commissioner of the FDA , prior to resigning, indicated that despite the current FDA status of CBD that there are alternative pathways that the agency could pursue. Gottlieb indicated that the public hearing was the first step in the FDA’s rulemaking process.

 

My personal opinion is that a contributing factor to Gottlieb’s resignation as Commissioner was his desire to avoid dealing with CBD policy, a political “hot potato.” The media attention that continually focused on CBD and its benefits, combined with a tremendous interest by consumers, and pressure from members of Congress, place the FDA in a very challenging no-win position.  

 

In announcing the public hearing, the FDA stated, “The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products. The FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”

 

The FDA indicated that there were a number of unanswered questions that it hoped would be addressed at the public hearing. These include whether there are any specific safety concerns with the use of CBD, whether pregnant women should use CBD, and what is the maximum daily dosage that should be allowed. The FDA’s announcement also raised concerns that since CBD has been approved as a drug, Epidiolex, that creating a pathway for CBD to be sold as a food supplement or for health, wellness or nutritional purposes may diminish the economic incentive for other scientific research including clinical trials.

 

Gottlieb also announced the formation of an internal working group to examine “potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”

 

It’s clear that the public hearing will be a high-profile event, with likely standing-room only attendance. But, as Gottlieb has previously indicated, the FDA moves at a snail’s pace, and the agency’s formulation of CBD policy could take years. He suggested that if all the stakeholders wanted a quicker resolution, that Congress should act. Despite support for CBD on both sides of the aisle, Congress’ dysfunction makes it unlikely that any new legislation will be forthcoming.

 

A recent game changer is the announcement by major retailers CVS, Walgreens, Rite Aid, Sephora, the Vitamin Shoppe and GNC are all now selling CBD-derived products despite all the FDA issues. So, it’s full-speed ahead for America’s fastest growing legal industry.

 

The safe harbor that most major CBD marketers are taking is to avoid making any medical or health claims, until a new FDA framework is in place. Also, small and large producers and marketers of CBD, including national retail chains are simply ignoring all the FDA issues. The general conclusion is that because of all the media attention to CBD, the popular support as well as support from both sides of the aisle in Congress, that the FDA will leave the CBD market alone until such time as the FDA adjusts its regulations to allow this new market. The one exception is the FDA will continue to go after marketers that are making medical or health claims, or product manufacturers that fail to disclose the actual product ingredients.

 

 

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