A Lost Ball in the High Weeds

If you’ve ever played golf, there’s no doubt you’ve lost at least one ball in the rough. After almost 10 hours of testimony on May 31 at the FDA, I think it is fair to say the FDA’s attempt to drive progress on CBD policy is lost in deep weeds – pun intended. Granted, the ability to regulate and enforce policy and safety standards can be just as hard as golf. Unlike golf, however, regulating the dietary supplement industry is not a game. The FDA’s progress and success directly impacts retailers and the customers they serve.

Our public democratic process enabled this day-long hearing to allow every possible stakeholder the opportunity to opine on the topic of CBD, including manufacturers, brands, retailers, researchers, consumers and the pharmaceutical industry. The salient points voiced through the meanderings of the day are artfully summed up in this tweet from Organic & Natural Health board member, Alan Lewis of Natural Grocers:

Consumer groups: Danger Will Robinson!

Public Health Docs: “I see dead people.”

Trial Lawyers: “Go Ahead. Make My Day.”

Big Pharma: “Kiss the Cook.”

Trade Groups: “You’re gonna need a bigger boat.”

Testing Labs: “You can’t handle the truth!”

Functional Doctors: “This is the beginning of a beautiful friendship.”

Growers: “It’s alive! It’s alive!”

Brands: “Open the pod bay doors, HAL.”

FDA: “Mrs. Robinson, you’re trying to seduce me. Aren’t you?”

Consumers: “You had me at hello.”

FTC: “I’ll get you, my pretty, and your little dog, too!”

Organic & Natural Health focused on one essential fact in our 2-minute comments: Full spectrum hemp extract is not the same article as the patented and approved drug Epidiolex, nor is it marketed with the intended use to treat disease. Therefore, it is not precluded from use as a dietary supplement.  

Not everyone agrees with our view that CBD is not a drug, and therefore should be regulated as a dietary supplement. Our adversaries believe the intended use of CBD is to treat disease, citing lack of GMP compliance as leverage. These adversaries include pharma, academic researchers, disease-based nonprofits (epilepsy and Alzheimer’s) and consumer advocacy organizations who emphatically call for CBD to be classified as a drug and continually reference this “medicine” being used to treat disease.  

When CBD broke into the market, no one anticipated it would go viral, much less be a key ingredient in a fast food burger. But it has, and it is now it is big business. This is a product with enormous potential for improving health, and a product easily shilled to uneducated consumers. How did we get to this place where retailers aren’t sure what they can and should place on their shelves?

Before the FDA’s CBD hearing, a smaller gathering was held at the agency on the topic of innovation, and the need for potential changes in the Dietary Supplement Health and Education Act (DSHEA). Much has changed since the enactment of this landmark legislation 1994. It’s a much bigger industry, it serves more people, and science is documenting how nutrient supplementation actually does improve health status. We are leading the way to sourcing ingredients derived from organic and regenerative practices, with an understanding that the health of people depends on the health of the planet. We are committed to education, not sales; people vs. market share; transparency vs. marketing. But with growth and success, comes the opportunity for problems.  

The purpose of the innovation hearing was to address the failings of our current law in light of the changes in the marketplace. The now age-old question about what constitutes a new dietary ingredient and the impetus to file such notification was a central theme. Perhaps it is no coincidence that CBD’s arrival on the scene is bringing these issues to the forefront. And yet, the safety of dietary supplements, especially in relation to pharmaceuticals, is solidly documented, demonstrating the vast majority of adverse events is directly related to consumption of convenience store and gas station products for weight loss, sexual performance and bodybuilding. We are seeing shady claims, adulterated and illegal ingredients sold by bad actors, with virtually no legal consequence. Even requiring product registration would have limited impact in our current marketplace unless the FDA had the ability, wherewithal and resources to pull unregistered product off the shelves, as Health Canada does. Policy work is cerebral, not so messy as compliance, nor does it require accountability.  

So where do we go from here? At the hearing we failed to raise a collective voice above the din of CBD detractors who are committed to ensuring this dietary supplement is mislabeled as a drug. The industry needs to organize the research results on CBD and present the data on dosage and health outcomes in a consumable way to our legislators, regulators and customers. We need to define a standardized vocabulary for broad-, full- and limited-spectrum hemp. We need to do the quality research to make our case for CBD and other innovative or new ingredients, and we need to do the research to document the value of nutritional supplementation. We also need to advocate for increased enforcement.  

The House of Representatives FY 2020 FDA/Agriculture Appropriations Committee report passed on June 4 is evidence of what happens when policy becomes the solution and it does not bode well for the supplement world:

Cannabidiol Regulatory Pathway. — The Committee is concerned about the proliferation of foods and dietary supplements marketed in violation of the Federal Food, Drug & Cosmetic Act (FFDCA), including products containing cannabis and cannabis-derived ingredients. Non-FFDCA-compliant products pose potential health and safety risks to consumers through unsubstantiated and misleading claims such as treating a wide-range of life-threatening diseases and conditions; excessive cannabidiol (CBD) concentrations that can result in harmful drug-drug interactions, somnolence, and elevated transaminases or liver toxicity; and the presence of significant levels of intoxicating compounds such as tetrahydrocannabinols (THC).

It’s Congress’ job to pass legislation (policy), the FDA’s job to regulate (enforce) and the industry’s job to fulfill the regulatory mandate (comply) and serve consumer needs.  

 

Note: The views and opinions expressed here are those of the author(s) and contributor(s) and do not necessarily reflect those of the publisher and editors of WholeFoods Magazine.

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Karen Howard, CEO and Executive Director of Organic & Natural Health Association
Karen Howard, CEO and Executive Director of Organic & Natural Health Association is a visionary and results-focused leader who has spent more than 30 years working with Congress, state legislatures and healthcare organizations to develop innovative healthcare policy and programs. She has held a variety of executive positions, including serving as professional staff for a Congressional committee, and has policy expertise in the diverse areas of integrative and complementary medicine, managed care, healthcare technology and mental health. An advocate at heart, she has worked to strategically advance the mission and vision of organizations through effective advocacy and strong collaboration. Prior to Organic & Natural Health, Howard served as executive director for both the American Association of Naturopathic Physicians (AANP) and the Association of Accredited Naturopathic Medical Schools. During her nearly 10-year tenure at AANP, she built a sustainable infrastructure, significantly improved financial performance, established a strong federal presence and supported multiple state association advocacy efforts for licensure. Also during this time, the naturopathic medicine profession established itself as a key component of comprehensive healthcare for the future. www.organicandnatural.org

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