The American Herbal Products Association (AHPA) built on its long tradition of partnering with a wide variety of stakeholders to foster a legal and regulatory environment where companies can thrive and consumers have informed access to safe, high-quality herbal products. In 2017, AHPA coordinated with key organizations to promote self-regulatory initiatives and advocate with a unified voice at the state and federal levels.
The following are a few highlights from 2017.
AHPA took proactive steps in 2017 to help the industry ensure that herbal raw materials used in consumer products are accurately identified, not adulterated, and meet quality standards throughout the supply chain. AHPA’s Good Agricultural Collection Practices and Good Manufacturing Practices (GACP-GMP) for Botanical Materials provides 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). Nutritional Outlook also recognized AHPA as a 2017 industry leader for building consensus among its members and providing tools for the good of the industry.
AHPA also partnered with CRN to build support for dietary supplements on Capitol Hill. AHPA helped CRN’s 18th annual Day on the Hill attract 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 event also enabled member companies to take an active role in advocating for reasonable regulation and to put a face on the responsible dietary supplement industry.
The Food and Drug Administration provided an opportunity in 2017 for the industry to provide input on the possible development of a list of pre-DSHEA dietary ingredients or old dietary ingredients (ODIs). At a public meeting held by FDA, I stressed that the agency must make some significant changes to previous positions on new dietary ingredients (NDIs) in order to successfully create an authoritative list of old dietary ingredients (ODIs).
AHPA also submitted comments to FDA that emphasized that all supplement, no matter if they include ODIs or NDIs, are held to the same standard under the adulteration clause of the Food, Drug and Cosmetic Act (FDCA). The law stipulates that a dietary supplement product is adulterated if it "presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling," or under ordinary conditions of use.
Medical Cannabis Standards
AHPA and the global standards organization, ASTM International, announced a Memorandum of Understanding in 2017 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.
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.
CA Prop 65
AHPA continued to help the industry navigate California’s Proposition 65 (Prop 65), the state’s well-intentioned law presents significant legal liabilities for companies selling herbs and herbal products. To help companies protect themselves, AHPA partnered with LifeScienceRisk to develop Prop 65 insurance coverage for the herbal product and dietary supplement industries.
Several chemical constituents that naturally occur in certain botanicals used in teas and dietary supplements are included on the Prop 65 warning list. Recently, two processed botanicals were also added to the list. To help the industry navigate legal liabilities related to naturally occurring substances in some natural products, AHPA updated its Proposition 65 guidance in 2017. The guidance covers heavy metals, naturally occurring constituents (pulegone and β-myrcene), goldenseal root powder and Aloe vera, non-decolorized whole leaf extract.
AHPA also continued Prop 65 advocacy efforts in 2017. AHPA submitted comments to the California Office of Environmental Health Hazard Assessment's (OEHHA's) on the carcinogenic hazards of the chemical coumarin. AHPA highlighted that coumarin is a natural constituent of some food plants and requested that all future OEHHA communications clearly state this fact and provide a representative list of these plants, which include lavender oil, some species of cinnamon, and sweet woodruff.
There continues to be growing interest by larger companies to expand into the natural health product markets by purchasing brands that have built a reputation for quality and ethical business practices. This is in line with the broader trend of natural health products being adopted by mainstream America.
Some examples of this in 2017 include the purchase of AHPA members Tazo and Pukka Herbs to Unilever and Nestle’s purchase of Atrium which owned several brands, including Garden of Life and Pure Encapsulations.
As the herbal products industry grows and evolves, AHPA will continue to capitalize on opportunities to help member companies and the entire herbal products industry thrive.