NIE talked with Michael McGuffin, president of the American Herbal Products Association (AHPA), about major events of 2017 and what we need to keep in mind as an industry in 2018
NIE: What do you feel were the biggest industry issues of 2017, and why?
McGuffin: The industry continued its long tradition of coordinating efforts to promote self-regulatory initiatives and advocacy with a unified voice at the state and federal levels. For example, AHPA developed and launched a free resource, the Good Agricultural Collection Practices and Good Manufacturing Practices (GACP-GMP) for Botanical Materials to provide a template to help growers, harvesters and processors implement and document best practices to ensure quality of herbal ingredients. The GACP-GMP resource has been endorsed by the Council for Responsible Nutrition (CRN), the United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA).
AHPA members and staff joined the Council for Responsible Nutrition (CRN) in June to co-produce CRN’s 18th annual Day on the Hill, which attracted nearly 100 dietary supplement industry representatives from across the country. The event provided an opportunity to recruit congressional members to join the Dietary Supplement Caucus (DSC), the bipartisan group of House and Senate members that works to raise congressional awareness of supplements and the laws and regulations governing the industry.
The caucus now includes 43 members, the largest number of members since its inception. The also allowed member companies to take an active role in advocating for reasonable regulation and to put a face on the responsible dietary supplement industry.
NIE: Companies are drilling down into better processing, better bioavailability, better delivery, and essentially better mousetraps. Is this good, and if so why? Are there no new mousetraps any more?
McGuffin: The industry should be applauded for continuing to proactively take steps to capitalize on technology and research that helps meet growing consumer demand for high-quality, effective products, industry transparency and ingredient traceability. The industry can be expected to continue to innovate to capitalize on the preferences of increasingly informed and discerning consumers.
NIE: Industry organizations have endorsed GMPs (good manufacturing practices) for botanicals, which is good, but this year has also been a banner year for kratom sales and adulteration with undeclared drug ingredients, such as sildenafil. What are we doing right? What do we need to do much better?
McGuffin: The industry continues to come together to speak out against illegal products masquerading as dietary supplements. AHPA has joined other trade groups to warn consumers about these dangerous products and to encourage federal and state agencies to use their full authority to take enforcement actions against criminals selling these misbranded and adulterated drug products. Strict enforcement of current laws and regulations combined with consumer education are two strategies that can reduce the risk of unlawful products.
NIE: Hemp madness is alive and well, in this case cannabidiol (CBD) oil. The FDA does not seem to be a fan of CBD as an ingredient in supplements, salves, balms and other non-medical delivery forms, correct? With a murky landscape of IND filings and some companies throwing in the towel, others are digging in their heels. Where do you think we will, or should, net out on CBD?
McGuffin: The growing state and consumer interest in providing broader access to products derived from cannabis continued in 2017. Despite remaining opposition at the federal level that creates an uncertain regulatory environment, companies selling these products continue to grow thanks to increasing consumer demand, new research that confirms the safety and efficacy of cannabis-derived products, and changing state laws that challenge federal prohibition.
AHPA continues to promote standards and best practices for medical cannabis, outlined in our recommendations to regulators. These recommendations for states that allow medical cannabis provide a framework for the oversight of cannabis production and distribution practices from seed to the consumer. AHPA and the global standards organization, ASTM International, announced a Memorandum of Understanding to work together on standards for the cannabis industry. Under the agreement, AHPA provides ASTM International with technical and regulatory recommendations to support coordinated development of standards for the cannabis industry.
Internationally, there also seems to be growing momentum to provide greater access to cannabis-derived products. The World Health Organization (WHO) recently issued a report that concludes that “current information … does not justify scheduling of the substance [cannabidiol (CBD)]” and that there will be another meeting in May 2018 “specifically dedicated to the pre-review of cannabis and its major components substances.
NIE: Where did we as an industry wind up with the whole ODI (old dietary ingredients) list process?
McGuffin: I presented at a public meeting held by FDA (U.S. Food and Drug Administration) in October to discuss the development of a list of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) dietary ingredients and stressed that FDA must make some significant changes to its previous positions on in order to accomplish their stated goal of creating a list that accurately reflects the ingredients in the market place before DSHEA was enacted.
AHPA also submitted comments to FDA in December that called attention to the fact that all ingredients (ODI and NDI) must meet the same safety standard under the adulteration clause of the Food, Drug and Cosmetic Act (FDCA).
NIE: What are your big predictions for 2018, in terms of category growth, specific supplements and ingredients, challenges and opportunities at wholesale and retail?
McGuffin: The last few years have seen a steady and significant growth in sales of consumer products made with herbal and botanical ingredients and we expect this to persist 2018 or beyond. Consumers may also be expected to continue to be willing to pay more for products that contain local, sustainably-produced, organic botanical ingredients. Larger companies will continue to find ways to purchase successful natural product companies to capitalize on the growth of this sector.
AHPA will continue to advocate for regulations that are reasonable and that seek to minimize economic burdens on U.S. businesses while simultaneously achieving regulatory goals or statutory requirements designed to protect consumers’ health and wellbeing.