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Americans for Safe Access Wants to Help You Navigate the Federal Regulatory Process

Earlier this spring, the Food and Drug Administration (FDA) issued a notice in the Federal Register that invited the public to submit scientific information and comments on cannabis and cannabis products. This is not the first time that the FDA has called for comments. In 2018, the FDA solicited public comments to help determine the United States’ position on the rescheduling of CBD and other cannabis compounds under international law. Fortunately, in recent years, there has been a shift in the FDA’s attitude about cannabis. Currently, their website acknowledges that states are developing their own programs and that there is medical value to, at a minimum, isolated components of the cannabis plant, marking a shift from previous years when the agency outright ignored the progress being made at the state level.

Regulatory comments are a good way for activists to make their voices heard. However, unlike typical grassroots campaign activities that rely on building coalitions and generating large scale support, regulatory comments do not benefit from a large number of people saying the same thing. In fact, the FDA itself specifies that the FDA comment process is not a popularity contest in which the agency will adopt the policy position promoted by the greatest number of commenters. What the FDA and other regulatory agencies look for during the commenting process are concise, well-thought-out responses that cite scientific research and make recommendations for sound public policy.

The FDA identifies very specific questions that it wants answered in Section III of the notice. These questions are listed in the subcategories of 1) Health and Safety Risks, 2) Manufacturing and Product Quality, and 3) Marketing/Labeling/Sales. The FDA is asking for input on 15 distinct questions, many of which have multiple subparts. A sampling of questions from each category have been summarized below:

Health and Safety Risks

a) Based on what is known about the safety of products containing cannabis and cannabis-derived products, are there particular safety concerns that FDA should consider regarding its regulatory oversight off these products?

i) How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety and exposure to cannabis and cannabis-derived compounds?

Manufacturing and Product Quality

a) What validated analytical testing is needed to support the manufacturing of safe and consistent products?

b) What are the functional purposes of adding cannabis-derived compounds, such as CBD, to foods (e.g., nutritive value, technical effect), both in terms of manufacturer intent and consumer perceptions and/or expectations? To the extent a compound is added to food to achieve a particular functional purpose, what evidentiary support is available to demonstrate that the addition of such compound has the intended or perceived effect?

Marketing/Labeling/Sales

a) How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about? Are there any subpopulations for which additional warnings or restrictions are appropriate? Please explain your reasoning.

b) What conditions, restrictions, or other limitations on the manufacturing and distribution of these products have been put in place under State or local law, particularly with respect to food products containing cannabis-derived compounds such as CBD (which may, in some cases, be lawful at the State level but not the Federal level)? What other conditions, restrictions, or other limitations might be appropriate to ensure adequate consumer information and to protect the public health?

What to Do

• DO read the submission guidelines carefully before submitting.
• DO include the docket number [FDA-2019-N-1482-0001] in the beginning of your comments either on a title page or in your introduction, especially if you mail them or submit them as an attached PDF.
• DO support your comments with scientific research. For example, instead of just describing how cannabis or cannabis-derived products helped your condition, look to see if there is research for other people with your condition to strengthen your anecdote.
  • Not effective: I used CBD to relieve my arthritis pain.
  • More Effective: Like many other individuals, I have had success using CBD for my arthritis pain. A 2016 study published in the European Journal of Pain found that the topical application of CBD had the potential to relieve pain and inflammation associated with arthritis. Additionally, according to the World Health Organization, “CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD.”

• DO include your contact information if you want the FDA to be able to follow up with you on your comments. Providing your contact information is not required.
• DO read the comments Americans for Safe Access is submitting before writing your own to get inspiration and ideas.

What not to do

• DO NOT try to answer all of the FDA’s questions. Pick one (or a few) and make sure your answers stay on topic.
• DO NOT make up data. If there is limited research on an area you are addressing in your comments, indicate that more research is needed and that the FDA should allow this research to proceed unimpeded.
• DO NOT limit your comment to a personal story. The two comments below have already been submitted to the FDA; while both are well-intentioned, they do not provide the FDA with enough specifics to create regulations or policy.

I want legal, regulated cbd products. Keeping it in this gray legal area is extremely harmful to people.

Do the right thing. CBD saves lives and works with our natural receptors in our body. Don't let big Pharma and greed control a natural substance that is derived from plants. Our Endocannabinoid system has receptors that benefit from CBD. It can help many illnesses and cut down our enormous health care costs in this country by healing the root causes for disease and not just putting bandaids on the symptoms.

• DO NOT use threatening, profane, or rude language. The comment below has already been submitted to the FDA; it will not receive serious consideration because it fails to answer any of the FDA’s questions and is threatening, profane, and rude.

Yo, ya demons wearin human suits, all yall mofos work for We The People. How dare yall think that yall kkkan tell grown folk what we can & cannot do? I HAVE PAID THE COST TO BE MY OWN BOSS! My Mama & Daddy are dead/no longer physically among us. Marijuana & all its constituents (CBD, THC, et al) have been my medicine for more than 50 years. I AM living proof of weed's medicinal properties. My long-term weed use has protected my brain & mostly kept me me, despite TWO strokes. 'legal' or not, weed WILL continue to medicate me. F**k yall. The tide is turning & prayerfully, the evil oppression that we've allowed to be 'in charge' is soon outie. DIE!

Your comments do not need to be completed in advance of the FDA hearing on May 31, 2019. In fact, you may hear information at the public hearing that you would like to incorporate into your comments. The FDA is accepting comments through July 2, 2019, and ASA will send periodic reminders about comment submission.

You can also watch our webinar discussion that walks you through the submission process.

You can submit comments of your own here.