When to Expect New FDA CBD Rules

When to Expect New FDA CBD Rules

February 5, 2019

With the legalization of hemp happening in the last weeks of 2018, consumers and legislators are pushing for new FDA CBD rules to help guide the hemp and CBD industries that are rapidly emerging in 2019.

Why We Need FDA CBD Rules for Hemp Products

With industrial hemp production is legal across the country, there is still a gray area when it comes to the legality of incorporating hemp-derived CBD in food, supplements, and cosmetics. While cannabidiol is a non-intoxicating cannabinoid and hemp itself is now considered legal, FDA Commissioner Scott Gottlieb said in December that the compound was still considered illegal if added to products without following his agency’s approval process.

Essentially, Gottlieb’s stance means all CBD oils and other items containing CBD exist in a gray area in terms of legality. While this has been the case for the past few years, 2018’s Farm Bill means that there is a new onus for the FDA and USDA to develop rules to guide hemp-related businesses through the processes of federal approval.

While the FDA has indicated it is willing to develop pathways of access for products containing hemp-derived CBD to enter the consumer market, new CBD rules have yet to emerge. Consumers aren’t the only people to notice either; lawmakers are now stepping in to urge the FDA to release CBD industry guidance sooner rather than later.

Lawmakers pushing the FDA to create CBD Rules

To that end, Oregon Senators Ron Wyden and Jeff Merkley wrote a letter to Gottlieb earlier demanding changes to the FDA’s current stance on hemp-derived CBD. In their letter, the senators noted that the FDA’s current stance causes financial hardships for farmers as opposed to benefiting the agriculture community, thereby also going against the intent of the Farm Bill.

“Farmers…nationwide are poised to make real economic gains for their communities once these regulations are updated,” they wrote. The letter was written on the heels of Congressional approval of the production and sale of industrial hemp and its derivatives. This isn’t the first time that Wyden and Merkley stepped up for hemp farmers; both were sponsors of the hemp provisions from the 2014 and 2018 versions of the omnibus Farm Bill.

Why Congress is Stepping in to Fight for CBD

Within hours the Farm bill was signed into law in December, FDA Commissioner Scott Gottlieb re-issued his agency’s stance that cannabidiol is considered a drug ingredient and as such is illegal to add to food or health products without the FDA’s approval. Gottlieb also noted in his statement that the FDA had already sent warning letters to companies making health claims about CBD products and that his agency would continue pursuing CBD companies making unauthorized claims about their products.

Calling the FDA’s stance “outdated,” the letter established that it was Congress’ intent to ensure producers and consumers are able to access hemp-derived products, including those containing CBD. CBD-infused oils have become increasingly popular in a number of different products, because of the expansive health benefits that can be experienced through incorporating CBD products into a wellness regime.

In addition to powerful anecdotal evidence, scientists are also building an impressive case for CBD through their work on animal and human subjects when it comes using CBD medicinally. While human studies on CBD have just started to get published, Harvard Medical School recognized CBD as the highly effective in treating medication-resistant childhood epilepsy syndromes.

In fact, despite their generalized stance against CBD, even the FDA acknowledges that the chemical has therapeutic potential. To that end, the FDA approved the first-ever CBD medicine for these conditions which contains cannabis-derived CBD. Studies suggest CBD may also help everything from anxiety and inflammation to insomnia and chronic pain.

In addition to calling for a change to existing regulations, the two Democratic Senators also asked for clarification in regard to several issues, requesting that the agency responds in 30 days after the government re-opened.

CBD Rule Questions Asked by Congress Included:

  1. What steps is the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplements, including into interstate commerce?
  3. Are there circumstances in which cannabis to TiVo and its derivatives may be permitted as a food, beverages, or dietary supplement by the agency?
  4. Will the agency consider issuing a regulation or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages, or dietary supplements that cross state lines?

Find Out What Happens Next with myCBD.org

With government open once again, the clock is now ticking for the FDA to establish a new rule to protect consumers while enabling producers and manufacturers of hemp-derived CBD products to access a market that has been legalized. Make sure you stay on top of all FDA CBD rules and industry updates with myCBD.org!

 

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