To Be or Not to Be … A Dietary Supplement?

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By Karen Howard

The explosion of CBD onto retail shelf space came as a surprise to the FDA, and they haven’t been able to contain the proliferation of products in the market. Perhaps they are doing their best. They had a 10-hour hearing last May and invited representatives from my industry, pharmaceutical companies, consumer organizations and research institutions to share opinions.  Disparate viewpoints ran amok. They continue to issue warning letters to companies making outrageous health claims. And, while the FDA’s promise of a regulatory solution remains evasive, consumers can now buy what might, or might not be, hemp-derived CBD in virtually every form, including nail polish.  

For the past few years, those of us in the dietary supplement space monitored the work of GW Pharmaceuticals as they developed and sought approval for the drug Epidiolex. This CBD-derived medication has seen tremendous results in reducing severe brain seizures in children.  CBD is one of more than 100 cannabinoids in the cannabis plant. Regulation states if an ingredient was approved first as a drug, it may not be classified as a dietary supplement. As a result, the FDA has determined CBD is in fact a drug, and therefore an illegal dietary supplement. (For the record, Organic & Natural Health disagrees with the FDA. Hemp-derived CBD bears little resemblance to the highly concentrated CBD isolate the agency has approved.)

This has clearly not dampened sales. In fact, the combination of the FDA’s declaration that CBD is a drug actually provides a bit of a safe haven for hucksters, who market these products without adhering to any regulatory requirements for good manufacturing practices, including testing to identify contaminants, or pesticides. Organic & Natural Health is deeply committed to full transparency and traceability of dietary supplements. Our concern relating to what we refer to as “gas station supplements” – products that skate compliance requirements and stand as a potential danger to consumers – has increased exponentially. We determined it was time to take action. We started with Amazon.

Unbeknownst to the public, Amazon deemed all hemp derived CBD products labeled as dietary supplements ineligible for sale when the FDA declared CBD could not be a supplement. Any quality company labeling its product correctly was barred from the site. What’s left are the products Amazon allows to be tagged as CBD. A simple search for CBD generates more than 10,000 results. We tested four of the products, including Amazon’s Best Seller, which in fact did contain CBD, albeit only 1%, and therefore, in violation of Amazon’s policy. The other three products were derived from hemp seed oil, which contains no CBD oil. Either way you look at it, consumers were being defrauded. Amazon could have put a notice on its site warning customers against buying CBD products. It chose not to.  

Our response was to create a consumer education campaign to help people identify a good product from a fake. 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 it seems too good to be true, it is.
  • Read the label. It needs to have a lot number and company contact information. There must be someone you can call with a question, to report an adverse reaction, or in the event of a recall.
  • The label should also include a recommended dose. Many products do not.
  • If the label says it’s been approved by the FDA, walk away. The FDA doesn’t approve dietary supplements.
  • Don’t buy CBD on Amazon, the largest of all gas stations. Remember, they say they don’t sell it and that prevents all quality companies from being on their site.

Consumers will need to do their research. Only buy from a trusted source. If you have a preferred dietary supplement company, start there. And, take the extra step of visiting the company’s website. Transparent companies will post a Certificate of Analysis (COA). The COA, while not foolproof, demonstrates the company is taking transparent steps to let consumers know what it in their product, and what it’s been tested for. These are the same companies that share information on their supply chain. Some have cameras in their manufacturing facilities so you can see how your products are made.  

Be aware that terminology is changing rapidly. Quality companies are moving away from labeling their products as CBD, in exchange for terms like hemp oil concentrate, full spectrum hemp (a hemp extract with less than .3% THC) or broad spectrum hemp (all THC has been removed from the extract). Don’t buy products labeled as hemp seed oil. The cannabinoids you seek are only in the plant, not the seeds.  

We recommend consumers seek guidance from practitioners trained to prescribe medical marijuana when available. Many dispensaries carry quality CBD products derived from hemp.  Also, if you are seeking treatment for serious health care issues, you should always consult with your personal physician.  

According to the Nutrition Business Journal, CBD sales-based product sales will reach $4 billion in 2023. Sales of topicals, a completely unregulated category, are the fastest growing segment.  Good CBD does amazing things for sleep, pain, and stress reduction. Anecdotal evidence of such has clearly outpaced the growing body of research we believe will demonstrate both safety and efficacy. For now, it’s buyer beware, and buyer be diligent. Join our Facebook page to stay current on the daily changes we are tracking.  

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.