03.28.19
To help ensure the industry complies with existing regulations, the American Herbal Products Association (AHPA) has adopted a new Guidance Policy for dietary supplement and food products that contain hemp and hemp-derived cannabidiol (CBD).
The guidance policy was developed to encourage industry to be mindful of the federal regulations that apply to these product categories, notwithstanding FDA’s ongoing review of the status of CBD and potential pathways for lawful addition of CBD to food and dietary supplements.
"FDA’s current position on the lawful status of CBD shouldn't be misinterpreted to mean that FDA does not regulate supplement or food products that contain hemp or CBD," said AHPA President Michael McGuffin. "Hemp and CBD companies should maintain compliance with established regulations for dietary supplement and food products to ensure quality and safety."
The policy recommends that any manufacturer, labeler, packer, holder or marketer of dietary supplements or foods that contain hemp or CBD comply with the following federal regulations:
AHPA develops guidance policies to promote responsible commerce in herbal supplements by addressing a variety of labeling and manufacturing issues. These policies reflect the consensus of AHPA members and Board of Trustees. AHPA encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices.
The guidance policy was developed to encourage industry to be mindful of the federal regulations that apply to these product categories, notwithstanding FDA’s ongoing review of the status of CBD and potential pathways for lawful addition of CBD to food and dietary supplements.
"FDA’s current position on the lawful status of CBD shouldn't be misinterpreted to mean that FDA does not regulate supplement or food products that contain hemp or CBD," said AHPA President Michael McGuffin. "Hemp and CBD companies should maintain compliance with established regulations for dietary supplement and food products to ensure quality and safety."
The policy recommends that any manufacturer, labeler, packer, holder or marketer of dietary supplements or foods that contain hemp or CBD comply with the following federal regulations:
- Food facility registration;
- Current good manufacturing and good agricultural practice regulations;
- Labeling requirements, including nutrition labeling, allergen disclosure, listing of required contact information, absence of drug claims, etc.;
- New dietary ingredient and food additive provisions, where applicable; and
- Applicable obligations for timely submission to FDA of any received serious adverse event reports associated with their products.
AHPA develops guidance policies to promote responsible commerce in herbal supplements by addressing a variety of labeling and manufacturing issues. These policies reflect the consensus of AHPA members and Board of Trustees. AHPA encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices.
