11 Replies to “Hemp”

  1. There are some conditions
    No Food Products & No Therapeutic/Medicinal Claims

    HEMP PRODUCTS NOT APPROVED FOR SALE The following products are NOT approved for sale in the Commonwealth pursuant to M.G.L. c. 128, Section 117(c) and are likewise prohibited for sale under FDA and DPH guidance:
    • Any food product containing CBD;
    • Any product containing CBD derived from hemp that makes therapeutic/medicinal claims;
    • Any product that contains hemp as dietary supplement;
    • Animal feed that contains any hemp products;
    • Unprocessed or raw plant material, including the flower that is meant for end use by a consumer.

    The Massachusetts Department of Public Health (“DPH”) is responsible for regulating food safety in the Commonwealth. DPH has recently issued policy guidance that is consistent with the FDA policy in prohibiting the manufacture or sale of any food or other consumable products containing CBD. Under the state health and sanitary code, local boards of health have authority to enforce public health laws and regulations within a municipality.

    https://www.mass.gov/files/documents/2019/06/12/MDAR%20Policy%20Statement%20Sale%20of%20Hemp.pdf

    Food or other Consumable Products?

    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.

    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.

    https://www.mass.gov/info-details/cbd-in-food-manufactured-or-sold-in-massachusetts

    Interstate Commerce? Soap Excluded!

    FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

    8. Is it legal for me to sell CBD products?

    A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

    10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

    A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355],

    13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

    A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

    https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers#cosmetics

    To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye. 21 CFR 701.20.

    https://www.fda.gov/cosmetics/cosmetic-products/frequently-asked-questions-soap

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