The Hemp Access and Consumer Safety Act is back before Congress...
The Hemp Access and Consumer Safety Act is back before Congress. The legislation aims to ensure hemp-derived CBD products are regulated by the U.S. Food and Drug Administration (FDA) like other legal products used in dietary supplements, foods and beverages.
Regulation of CBD Products
As we have discussed in prior articles, hemp-derived cannabidiol (CBD) remains in a regulatory grey zone despite the 2018 Industrial Hemp Farming Act. The law removed “hemp” from the Controlled Substances Act’s (CSA) definition of marijuana, which means that cannabis plants and derivatives that contain no more than 0.3% THC on a dry-weight basis are no longer controlled substances under the CSA.
The 2018 Farm Bill also authorized the transfer of hemp-derived products across state lines for commercial or other purposes and removed any limitations on the sale, transport, or possession of hemp-derived products, provided that such products are produced in accordance with the law. Notably, the 2018 Farm Bill did not modify the authority of the Secretary of Health and Human Services or Commissioner of Food and Drugs to regulate hemp under applicable U.S. Food and Drug Administration (FDA) laws.
Currently, the Federal Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition, but has declined to do so. In January, the FDA formally concluded that the existing regulatory framework for food and supplements was inappropriate for CBD and called on Congress to act.
Key Provisions of Hemp Access and Consumer Safety Act
A bi-partisan group of lawmakers, including U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., recently reintroduced the Hemp Access and Consumer Safety Act, which would allow the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods, and beverages.
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back. […] The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD,” Senator Wyden said in a press statement.
The Hemp Access and Consumer Safety Act would:
Give hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act;
Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD; and
Ensure that CBD products are properly labeled.
Several cannabis organizations have endorsed the bill, including U.S. Hemp Roundtable, Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, We Are For Better Alternatives (WAFBA), American Herbal Products Association (AHPA), Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), Veterinary, Cannabis Society, Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, and the Virginia Hemp Coalition.
Key Takeaway
The growth of the hemp industry has been hampered by the FDA’s position that companies marketing CBD products should be required to prove that they are safe and effective, much like is required for pharmaceuticals. While it has a long way to go before becoming law, the Hemp Access and Consumer Safety Act would help establish a reliable framework for the production, marketing, and sale of hemp-derived CBD products.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
This article is a part of a series pertaining to cannabis legalization in New York, New Jersey and the United States at large. Prior articles in this series are below:
Disclaimer: Possession, use, distribution, and/or sale of cannabis is a Federal crime and is subject to related Federal policy. Legal advice provided by Scarinci Hollenbeck, LLC is designed to counsel clients regarding the validity, scope, meaning, and application of existing and/or proposed cannabis law. Scarinci Hollenbeck, LLC will not provide assistance in circumventing Federal or state cannabis law or policy, and advice provided by our office should not be construed as such.
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What the Cannabis Industry Should Know About the Hemp Access and Consumer Safety Act
Author: Daniel T. McKillop
The Hemp Access and Consumer Safety Act is back before Congress...
The Hemp Access and Consumer Safety Act is back before Congress. The legislation aims to ensure hemp-derived CBD products are regulated by the U.S. Food and Drug Administration (FDA) like other legal products used in dietary supplements, foods and beverages.
Regulation of CBD Products
As we have discussed in prior articles, hemp-derived cannabidiol (CBD) remains in a regulatory grey zone despite the 2018 Industrial Hemp Farming Act. The law removed “hemp” from the Controlled Substances Act’s (CSA) definition of marijuana, which means that cannabis plants and derivatives that contain no more than 0.3% THC on a dry-weight basis are no longer controlled substances under the CSA.
The 2018 Farm Bill also authorized the transfer of hemp-derived products across state lines for commercial or other purposes and removed any limitations on the sale, transport, or possession of hemp-derived products, provided that such products are produced in accordance with the law. Notably, the 2018 Farm Bill did not modify the authority of the Secretary of Health and Human Services or Commissioner of Food and Drugs to regulate hemp under applicable U.S. Food and Drug Administration (FDA) laws.
Currently, the Federal Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition, but has declined to do so. In January, the FDA formally concluded that the existing regulatory framework for food and supplements was inappropriate for CBD and called on Congress to act.
Key Provisions of Hemp Access and Consumer Safety Act
A bi-partisan group of lawmakers, including U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., recently reintroduced the Hemp Access and Consumer Safety Act, which would allow the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods, and beverages.
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back. […] The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD,” Senator Wyden said in a press statement.
The Hemp Access and Consumer Safety Act would:
Give hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act;
Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD; and
Ensure that CBD products are properly labeled.
Several cannabis organizations have endorsed the bill, including U.S. Hemp Roundtable, Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, We Are For Better Alternatives (WAFBA), American Herbal Products Association (AHPA), Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), Veterinary, Cannabis Society, Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, and the Virginia Hemp Coalition.
Key Takeaway
The growth of the hemp industry has been hampered by the FDA’s position that companies marketing CBD products should be required to prove that they are safe and effective, much like is required for pharmaceuticals. While it has a long way to go before becoming law, the Hemp Access and Consumer Safety Act would help establish a reliable framework for the production, marketing, and sale of hemp-derived CBD products.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
This article is a part of a series pertaining to cannabis legalization in New York, New Jersey and the United States at large. Prior articles in this series are below:
Disclaimer: Possession, use, distribution, and/or sale of cannabis is a Federal crime and is subject to related Federal policy. Legal advice provided by Scarinci Hollenbeck, LLC is designed to counsel clients regarding the validity, scope, meaning, and application of existing and/or proposed cannabis law. Scarinci Hollenbeck, LLC will not provide assistance in circumventing Federal or state cannabis law or policy, and advice provided by our office should not be construed as such.
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