Daniel Fabricant, president & CEO of the Natural Products Association (NPA), has sent a letter to Colorado State Senate President Steve Fenberg, in which he expressed “grave concern” over Senate Bill 23-271, “a bill related to the regulation of compounds that are related to cannabinoids.”
Fabricant wrote, “The time for enforcement of CBD is long overdue. Across the country, we are seeing state after state recognizes the gaps left by the FDA and begin to develop their regulatory standards. Currently, over two dozen states have introduced or passed legislation regulating CBD as a dietary supplement or food ingredient. While it is our opinion that the best approach is for one uniform national standard. We understand the FDA has yet to take responsibility for this public health issue and establish a regulatory framework for manufacturers that would include establishing a safe daily level of consumption, inspecting facilities for manufacturing practices, and testing products for impurities such as high dosages of tetrahydrocannabinol (THC), pesticides and heavy metals.
“In the past five years, over 3,000 CBD products have come to market without a consistent approach to regulation or any plan on how consumer access will be balanced with consumer safety by our public health officials at the Food and Drug Administration. NPA commissioned a poll that found seven in 10 Americans believe the FDA is overdue to establish safety standards for CBD products in the marketplace. To make matters worse, 41 [percent] wrongly assumed the FDA had already developed these safety standards.
“CBD was first marketed as an active pharmaceutical ingredient (API), which creates some legal hurdles in marketing it as a dietary supplement or conventional food. The industry needs to be provided with guidelines they need and consumers the assurance that what they are consuming is safe and is manufactured to quality standards. FDA has previously provided a path to market as dietary supplements/foods for natural products that contain an API by establishing a daily exposure level similar to what they did with monacolin K, the same ingredient that is in the prescription cholesterol lowering drug lovastatin, which is found in red yeast rice.”
He continued, “We have seen several products in both the drug and supplement products, including caffeine, folate, niacin, lovastatin and lithium. The critical differences in those cases are 1) the type of claims that can be made and 2) the dosage. While FDA has said that CBD is different, it most parallels lovastatin which was debated in court. To this day, lovastatin is available on the market, and it contains monacolin K. FDA at present only enforces when it finds a lovastatin product at approximately half the effective lowest dose of lovastatin. They do this based on a Health Hazard Evaluation (HHE), which the FDA has failed to produce for CBD.”
“The tension between state and federal positions is quite clear. As mentioned, over two dozen currently allow the sale of hemp and CBD as a food or dietary supplement, and the list continues to grow. NPA supports the ability for states to make determinations based upon facts and findings presented before them. NPA also is urging Congress to mandate the FDA establish dosage recommendations along with an official method of analysis for CBD products. The implementation of these regulations would serve as the uniform standard for testing foods and dietary supplements that purport to contain CBD. However, SB 23-271 is at odds with federal labeling laws for foods and dietary supplements while also undercutting federal case law in that it now defines consumption as inhalation.”
Fabricant concluded, “It’s been almost 30 years since [the Dietary Supplement Health and Education Act (DSHEA)] became effective, and FDA has yet to use this central part of the law to allow for an ingredient with safety data like CBD to be used. The dosage submitted in our Citizen’s petition was approximately 75 mg a day which is 10x lower than the 700 mg + that is used for the drug Epidiolex. FDA has wasted considerable time claiming confusion on CBD when the pathway is for them to write a proposed rule, or in the interim, exercise a policy of enforcement discretion via guidance or interim final rule, which they could establish a process of reviewing any CBD product via NDI notification and establishing a daily upper limit, which would ensure consumers that FDA is fulfilling their mandate as a science-based agency to review new items in the diet. While we understand the intent of the legislation, the fact remains that in its current form, the legislation in its current form is at odds with federal law. We strongly urge the legislature to oppose the bill in its current form.”
For more information, visit www.npanational.org.
