Guest article

CBD, regulatory creep, and continued growth top AHPA's 2019 high points

By Michael McGuffin, president, American Herbal Products Association

- Last updated on GMT

© Getty Images / marekuliasz
© Getty Images / marekuliasz

Related tags: Cbd, hemp extracts, Hemp, Regulation

Questions surrounding the hemp/CBD trade, a recognition of the continued popularity of herbal supplements, and a casting a wary eye toward regulatory creep topped the list of 2019 concerns for the American Herbal Products Association.

It’s impossible to look back on 2019 and forward to 2020 without seeing the dramatic impact of the emerging hemp and cannabidiol (CBD) industry. 2020 will mark the 10-year anniversary of AHPA’s Cannabis Committee which is using knowledge from the established herbal supplement industry to guide the emerging hemp-CBD industry.

There is an historical parallel to today’s vacuum in guidance from the Food and Drug Administration (FDA) for hemp and CBD producers. FDA was not supportive of the Dietary Supplement Health and Education Act (DSHEA) when it passed in 1994, and reports circulated that the agency had determined to simply not enforce the law in the hope that the industry would behave so badly that Congress would repeal DSHEA. But that didn’t happen. 

Instead, the industry grew and grew, and trade associations petitioned FDA to adopt formal current good manufacturing practice (cGMP) regulations, and then worked with lawmakers in Congress to pass a new law making serious adverse event reporting (SAER) mandatory. Here we are 25 years later with a robust industry that is well regulated and providing over half of Americans with dietary supplements in their individual health care choices.

Lessons for the CBD trade

This industry can learn much from the broad herbal supplement industry should adopt practices that comply with current supplement regulations, despite the absence of a clear regulatory framework. Hemp and CBD companies should be familiar with the FDA rules for dietary supplements that govern labeling, current good manufacturing practice, and serious adverse event reporting. The industry is working to convince FDA to make all of these applicable, so the trade should become acquainted with these now. FDA’s early resistance in the 1990s to the input of the supplement industry was eventually overcome by a number of factors, not the least of which the agency’s observation that there were many responsible companies emerging in leadership positions in that trade.

The emerging hemp industry can also learn much from the established herbal industry when it comes to supply chain management to ensure confidence in raw material sources. There are a number of legacy herb companies that know the exact source of every botanical ingredient in their products.

This direct relationship with source allows marketers to maintain better control over their supply and builds supply and product consistency. There is almost certainly a higher financial cost to this approach, much of which is intentional; if you are always buying your echinacea, or your chamomile – or your hemp or CBD – from the same company you are invested in their success and seeking the cheapest price is not a priority.

Continued growth in popularity of herbal supplements

We also witnessed continued growth in popularity of herbal supplements in 2019. U.S. sales data indicate a broad—and broadening—acceptance by American consumers of herbal supplements. According to HerbalGram​, the U.S. retail value of herbal supplements was nearly $9 billion in 2018. This reflects a doubling of sales volume in the last decade, and, depending on the source of earlier information, a 5- to 20-fold increase in the last 25 years.

This shouldn’t be a surprise. From an historical perspective, use of botanicals have almost always been the norm, rather than the exception. It was only in our recent history that we abandoned this norm, and what we are witnessing now may just be a correction to our culture’s blind embrace of modernity in the early- to mid-20th​ century. We continue to witness a resurgent and growing focus on healthy living and holistic wellness as a way for consumers to take responsibility for their healthcare and improve quality of life, and herbs are just one part of this overall trend. There is nothing to indicate that these trends are going to slow any time soon.

The growing popularity of herbs, herbal products and herbal ingredients in products makes sustainability an issue of ever-increasing importance. AHPA recently established a Sustainability Committee to work with our members to develop solutions and best practices for herbal product companies to promote sustainability. Fortunately, the industry is generally supportive of sustainability efforts and many consumers have communicated strong support these efforts, and will hopefully reward companies that demonstrate progress in furthering sustainability goals.

We will also need to continue to pay attention to product quality in the herbal marketplace. I think we can best summarize the current reality by acknowledging that high quality companies make and market high quality products, but that poor quality companies put poor quality products in the market. This is to some degree related to demand from some customers for cheap prices, and we as an industry need to learn how to communicate to the public that cost should almost never be the first priority in selecting health products.

Regulatory creep

At the same time, I am concerned about the tendency for “regulatory creep” that seems to come naturally to many government agencies, and an apparent drift by some such agencies toward less transparent communications with the trade and the public. Of equal concern is that some in the trade are taking positions in support of increasing agencies’ regulatory authority without clearly articulating how increased authority would benefit consumers or the trade, or would at least hold out the promise of fixing specifically identified problems. 

As an example, I recently heard a representative of a key regulator defend a controversial position taken by the agency in a light-hearted manner. The representative rhetorically asked why industry would expect the regulator to take a different position, observing that by their nature regulators love to regulate. Although this response seemed tongue in cheek, I believe it also reflected a basic truth about how some regulators view their roles and functions. Nevertheless, I continue to believe that resisting the regulatory drift implied by this reply best serves the interests of the trade and our consumers. 

I acknowledge that exceptional cases in which increased regulation can help deliver clear benefits and solve identified problems can arise, and I take pride in AHPA’s track record of supporting improvements to the regulatory framework in these cases.

There were certainly times in my career when supplements were a bigger target for lawmakers in Congress and regulators than they’ve been in the last few years. We have heard recently from some of our most staunch Congressional critics that they no longer give much attention to our products and don’t now have much concern for our category. It’s unlikely, though, that critics of supplements, or of any industry that challenges the status quo, will ever completely disappear, so AHPA continues to monitor media coverage of the industry and actively responds to inaccurate or misleading coverage.

More affirmatively, AHPA continues to use data to evaluate the safety of dietary supplements. This year we published an article that evaluated all of the recalls reported by FDA to date in 2019 for any FDA-regulated products. Not surprisingly, what we found was that less than 2 percent of the more than 800 such recalls were associated with any dietary supplement product. We intend to continue this focus on getting factual information to the trade, as well as to consumers and government officials, and we hope to continue to change the narrative with the addition of this important data on the safety of dietary supplements.

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