Despite the fact that DSHEA, the Dietary Supplement Health and Education Act, was passed 25 years ago in the U.S., the dietary supplement industry continues to deal with misinformation stating that dietary supplements are unregulated—often accompanied by media hype over research reports stating that dietary supplements don’t impact health status. This is often, in fact, the first question I am asked during a media interview: Are dietary supplements regulated? Decidedly, they are.
Still, there are challenges as well as ongoing efforts to improve how supplements are regulated. As the FDA has continued to drive change through the slow bureaucratic processes it is bound by, the supplements industry itself has responded to issues regarding safety, encouraging self-regulation as well as appropriate regulatory enforcement and tools. We’ve engaged in energetic discussions with the FDA regarding mandatory product registration. We continue to discuss the issues surrounding registration of new dietary ingredients, for instance. All the while, we have watched internet sales of dietary supplements explode, turning efforts to ensure regulatory compliance into a game of whack-a-mole.
Perhaps no ingredient better demonstrates the challenges of market regulation than hemp cannabidiol (CBD). Ever since Congress passed the 2018 Farm Bill declaring hemp (under a 0.3% tetrahydrocannabinol (THC) content threshold) as a legal agricultural crop, nothing has been the same. There has been no idiom spoken that articulates the magnitude of influence that legalization of hemp and the formation of a CBD market have had on our industry.
Where food and supplements are concerned, the lack of regulatory framework or authorized use of CBD from FDA persists against a proliferation of products now on the market labeled as containing CBD, which includes everything from supplements to nail polish. While FDA continues to request safety data from the industry, today’s modern snake oil salesmen have stepped up their game and now dominate online sales with outrageous CBD claims directed at consumers who need access to a natural product to help their issues with sleep, chronic pain, and stress. Now, vape stores, sensing their regulatory demise, are transitioning to sales of CBD products. Concerns relating to products that may lack current Good Manufacturing Practices (cGMP) compliance and that may present potential danger to consumers have increased exponentially. Last fall, the Organic & Natural Health Association determined it was time to take action. We started with Amazon.
The Organic & Natural Health Association alerted the public about concerns the association had about CBD policies and products sold on retailer Amazon.com. While Amazon says it forbids the sale of CBD-containing products on its site, the Organic & Natural Health Association has found that this hasn’t prevented companies from selling CBD products on Amazon. For instance, when the Organic & Natural Health Association hired testing laboratory Alkemist Labs (Garden Grove, CA) to test several products sold on Amazon, the lab found the presence of CBD (at a low 1% level) in an Amazon bestseller, New Age Premium Hemp Oil. What’s more, we have found that Amazon did not take steps to monitor illegal CBD claims nor has it told its customers it does not allow CBD products on its “shelves.” In response, we have created a consumer education campaign to guide people through the morass of label claims, certification, and legalities of hemp-derived products.
Here are the red flags we recommend consumers watch for:
- Do not buy a product that claims to treat, cure, or mitigate disease. It’s illegal to say those things, and if a product seems too good to be true, it is.
- Read the label. It needs to list a lot number and company contact information. There must be someone you can call at the company if you have a question, to report adverse reactions, or in the event of a recall.
- The label should also include a recommended dose. Many products don’t.
- If the label says the product has been approved by the FDA, walk away. The FDA doesn’t conduct premarket approval of dietary supplements.
- Don’t buy CBD on Amazon, considering the fact that Amazon’s policies prohibiting CBD products prevents all responsible CBD companies from being on their site.
What we do recommend is that consumers go to a trusted source, a dietary supplement company they have researched and/or use regularly. If they are new to this world, we suggest they watch for the red flags above and do a quick analysis, then visit the company’s website to find a Certificate of Analysis (CoA). The CoA, while not foolproof, demonstrates the company is taking transparent steps to let consumers know what is in its product and what it’s been tested for.
We also recommend consumers seek guidance from practitioners trained to prescribe medical marijuana when available. Many dispensaries carry quality CBD products derived from hemp. And, we also state that serious healthcare issues need to be addressed in consultation with personal physicians.
There is nothing new or clever about this education campaign. Most of us dispense this advice regularly. What is new is the urgency to effectively disseminate the information pertaining to CBD. Consumers are spending large sums of money on CBD products. If we are to continue applauding growth of the dietary supplements market, it is essential we do everything in our power to support consumer interests. After all, it’s consumers who effect real change in the marketplace.
Karen Howard, CEO and executive director of the Organic & Natural Health Association (Washington, DC), 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 her role at the Organic & Natural Health Association, 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. Visit www.organicandnatural.org or @OrgNatHealth.