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 hemp-derived CBD or THC to 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 laws and must not contain any prohibited ingredients. The FDA has concluded that the Federal Food, Drug and Cosmetic Act prohibits the addition of hemp-derived CBD and THC to food products because CBD and THC are active ingredients in FDA-approved drugs. Since CBD and THC are not approved ingredients under the Food, Drug and Cosmetic Act, they may not be added to manufactured foods. For more information about manufactured foods, please contact the Food Protection Program at fpp.dph@mass.gov.
If I have a Massachusetts permit under 105 CMR 590 (Regulations for Minimum Sanitation Standards for Food Establishments) as a Food Establishment, is it legal to add hemp-derived CBD or THC to food I distribute at retail?
No. 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 or THC to food products because CBD and THC are active ingredients in FDA-approved drugs. Since CBD and THC are not approved ingredients under federal law, they may not be added to foods distributed at retail. For more information about food sold in retail, please contact your local board of health.
I manufacture a carbonated non-alcoholic beverage that includes hemp-derived CBD and/or THC as an ingredient. May I sell this product in Massachusetts?
No. The bottling and sale of water and non-alcoholic carbonated beverages is regulated by Massachusetts law, including the Regulations for Good Manufacturing Practices for Food discussed above (see G.L. c. 94 §10A; 105 CMR 500.090 et seq). As with other food, since CBD and THC are not approved ingredients under the Federal Food, Drug and Cosmetic Act, they may not be added to bottled water and carbonated non-alcoholic beverages.
Other resources regarding bottled water are available here: https://www.mass.gov/lists/bottled-water-resources.
I hold an alcoholic beverage retail license. May I sell a carbonated non-alcoholic beverage that includes hemp-derived CBD and/or THC as an ingredient?
No. The bottling and sale of water and non-alcoholic carbonated beverages is regulated by Massachusetts law, including the Regulations for Good Manufacturing Practices for Food discussed above (see G.L. c. 94 §10A; 105 CMR 500.090 et seq). As with other food, because CBD and THC are not approved ingredients under the Federal Food, Drug and Cosmetic Act, they may not be added to bottled water and carbonated non-alcoholic beverages. Only retail establishments licensed and regulated by the Cannabis Control Commission may sell beverages that include THC as an ingredient.
I manufacture a product that contains “full-spectrum,” “broad-spectrum,” or “whole plant” hemp extracts. Can these extracts be added to food or beverages in Massachusetts?
No. Because “full-spectrum,” “broad-spectrum” and “whole plant” hemp extracts are made from parts of the hemp plant that include hemp flower, they contain CBD, THC, and other cannabinoids. Whether the product label indicates the presence or concentration of these cannabinoids, they contain CBD and/or THC and may not be added to food.
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) to process hemp. Is it legal for me to add CBD or THC to manufactured or retail food?
No. The MDAR Hemp Program does not provide an exception to the Food, Drug and Cosmetic Act's prohibition against adding CBD or THC 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.
Is it legal to process or sell hemp-derived delta-8 THC products in Massachusetts?
No. The MDAR Hemp Program has stated that because delta-8 THC is not naturally occurring in hemp (except for possible trace amounts), to produce delta-8 THC in commercial quantities it must be derived from hemp synthetically. While the Farm Bill did remove hemp from the Controlled Substances Act, it did not impact the control status of synthetically derived cannabinoids, thus delta-8 THC remains a controlled substance, regardless of the source. As a result, the MDAR Hemp Program does not allow hemp-derived delta-8 THC products to be processed or sold in Massachusetts.
May I sell cosmetic products containing hemp, CBD, or THC at retail in Massachusetts?
The FDA has advised that under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.
For more information on cannabis and cannabis-derived ingredients in cosmetics, please visit the FDA’s Frequently Asked Questions.
What can I do if I had an adverse reaction to a cosmetic product labeled as containing CBD or THC?
You can report a cosmetic related complaint directly to the FDA. FDA tracks these through their Adverse Events Reporting System (FAERS).
Where can I find additional information on medical and adult use marijuana, or hemp in Massachusetts?
For more information regarding medical and adult use marijuana, please contact the Cannabis Control Commission.
For more information regarding hemp-derived products, please contact the Massachusetts Department of Agricultural Resources (MDAR).
Additional Resources
Date published: | June 12, 2019 |
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