Frequently Asked Questions
If I have a Massachusetts license or permit under 105 CMR 500 (Regulations for Good Manufacturing Practices for Food) to manufacture food, is it legal to add cannabidiol (CBD) to that food?
No. The Massachusetts Department of Public Health (DPH) regulates food manufacturing in the Commonwealth (see 105 CMR 500). These regulations require that all food must be from approved sources that comply with federal, state, and local law and must not contain any prohibited ingredients. The FDA has concluded that federal law prohibits the addition of CBD to food products because CBD is an active ingredient in FDA-approved drugs. Since CBD is not an approved ingredient under federal law, it may not be added to manufactured foods.
If I have a Massachusetts permit under 105 CMR 590 (Minimum Sanitation Standards for Food Establishments) as a Food Establishment, is it legal to add CBD to food I distribute at retail?
No. The DPH sets minimum sanitary standards for food establishments in the Commonwealth. These regulations are enforced by local boards of health in partnership with the state (see 105 CMR 590). The regulations incorporate the FDA’s Food Code, which requires that food be obtained from sources that comply with federal, state, and local laws and must not contain any prohibited ingredients. As noted above, the FDA has concluded that federal law prohibits the addition of CBD to food products because CBD is an active ingredient in FDA-approved drugs. Since CBD is not an approved ingredient under federal law, it may not be added to foods distributed at retail.
If I am licensed or permitted as a food manufacturer or retailer in Massachusetts, is it legal to add hulled hemp seeds, hemp seed protein, and/or hemp seed oil to food I manufacture and/or sell at retail?
Yes. The FDA has completed its evaluation of generally recognized as safe (GRAS) notices for hulled hemp seeds, hemp seed protein and hemp seed oil. These products can be legally added to human food, provided they comply with all other requirements.
I have a license issued by the Massachusetts Department of Agricultural Resources (MDAR) under its Interim Commercial Industrial Hemp Program Policy. Is it legal for me to add CBD to manufactured or retail food?
No. The MDAR Hemp Program does not provide an exception to the federal prohibition against adding CBD into food products.
May I market my hemp products (e.g., hulled hemp seeds, hemp seed protein and hemp seed oil) by making therapeutic claims without FDA approval?
No. The FDA has reiterated that cannabis products (hemp-derived or otherwise) that are marketed with claims of therapeutic benefit or any other disease claim must be approved by the FDA.
May I sell cosmetic products containing hemp or CBD at retail in Massachusetts?
DPH does not regulate cosmetics. The FDA has issued Frequently Asked Questions that address cannabis and cannabis-derived ingredients in cosmetics.
What can I do if I had an adverse reaction to a cosmetic product labeled as containing CBD?
You can report a cosmetic related complaint directly to the FDA.
|Date published:||June 12, 2019|