Michael McGuffin, President of the American Herbal Products Association (AHPA)

2023 Year in Review + 2024 Forecast

by Michael McGuffin, President, AHPA

Compliance with complex compliance requirements can be challenging for the natural products industry, both as new statutes and regulations come into effect in 2024 while other, existing requirements still need modernizing to meet the needs of the current market. Manufacturers and marketers of cosmetics, for example, will be subject to new requirements under the federal Modernization of Cosmetics Regulation Act (MoCRA) in 2024, including new serious adverse event reporting requirements and significantly expanded government access to manufacturer records. 

Consumer interest in dietary supplements and natural products peaked during the COVID-19 pandemic and remains high as health interests have expanded from just immune health to also include support for mood, focus, and performance. Although the category is diversifying and growing to meet demand, responsible industry is hampered by both restrictions on what ingredients companies may use and how they may communicate to consumers.

The FDA's prior drug exclusion clause, invoked in decisions related to CBD, NAC, and NMN, bars products from qualifying as "dietary supplements" if they contain substances initially approved or studied as drugs before their use in the conventional food or dietary supplement industry, despite meeting other criteria for "dietary ingredients." This legislation permanently prevents consumer access to dietary supplements with such ingredients. In contrast, if an ingredient debuts in the dietary supplement market, the pharmaceutical industry can later develop a drug with the same ingredient, which may coexist in the market. This disparity constrains consumer options, persisting long after pharmaceutical incentives for ingredient development have diminished or disappeared.

Further, consumers would also benefit from the removal of current legal restrictions that require certain scientific publications to be “physically separate” from dietary supplements. In practice today, with many consumers buying their health products online, this law limits the ability of responsible companies to share truthful and not misleading information with the public. The companies investing resources into studying ingredients should be able to provide the results of scientific research to consumers to assist them in making the most informed decisions about the products they buy to support their health.

AHPA closely engages with FDA to influence and encourage improvements to the regulation of dietary supplements. Our advocacy is especially important considering FDA’s history of imbalanced treatment of dietary supplements—especially when compared to the agency’s attitude toward pharmaceuticals—and perceived inattention to the regulation of food overall. For the agency’s part, FDA plans to reorganize and create a unified Human Foods Program (HFP) to improve the agency’s regulation of food, including dietary supplements. The reorganization would move the Office of Dietary Supplement Programs (ODSP) under a new Office of Food Chemical Safety, Dietary Supplements & Innovation, and AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities with new organizational structure.

With the FDA reorganization on deck, new regulations coming into effect, and more work to do to modernize regulations to better serve our family members, friends, and neighbors, it will be crucial in 2024 for industry to stay engaged with representatives in Congress and support trade associations, including AHPA. Outreach to lawmakers is crucial as it allows industry members to have their voices heard and contribute to the shaping of policies that directly impact their businesses and the wellbeing of the public. Additionally, supporting trade associations helps to amplify the industry's influence and ensure that it remains well-represented in discussions about regulating our health-promoting products. By fostering collaboration and maintaining a proactive stance, industry members can play a pivotal role in shaping a regulatory environment that aligns with the evolving needs of the community.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from CRN, CHPA, INFRA, NPA, Organic & Natural Health, and SENPA!