KINGSTON, NY—This week, Representative Antonio Delgado (NY-19) and colleagues from the House Small Business Committee sent a letter to the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) on economic opportunities relating to the growth and production of hemp and cannabidiol (CBD) for the farming community and small businesses. The letter articulates the members’ support for CBD’s potential to build growers’ capacity and economic development during this down farm economy; and urges the FDA to provide regulatory guidance on CBD products to support American farmers and entrepreneurs in this growing market. Rep. Delgado was joined on the letter by fellow members of the House Small Business Committee, including Chairwoman Nydia Velazquez (NY-07), and Reps. Dwight Evans (PA-03), Adriano Espaillat (NY-13), and Jared Golden (ME-02).
The letter reads, “As Members of the House Committee on Small Business, we appreciate the opportunity to provide comments to the Food and Drug Administration (FDA) on products containing cannabis or cannabis-derived compounds. Farmers, entrepreneurs, and small businesses around the country are ready to engage in this new industry that will create jobs and spur economic growth.”
“The passing of the 2018 Farm Bill ushered in the potential for a new agricultural industry that will impact textiles, paper, pharmaceuticals, dietary supplements, and countless other consumer products. Since small businesses comprise over 99 percent of all employers in the United States, the legal cannabis industry provides an opportunity for small firms to lead the way by fueling local economies and creating new jobs.” The letter continues, “Congress has been clear in legalizing the growth and production of hemp and hemp-derived compounds. Farmers around the country are eager to adopt a new exciting crop and are enthusiastically awaiting the establishment of a regulatory framework from the United States Department of Agriculture (USDA). Businesses are ready to capitalize on the growing consumer demand for hemp and hemp-derived products, such as cannabidiol (CBD), yet the FDA’s lack of clarity has caused confusion for farmers, businesses, and consumers. We are pleased that in recent months, FDA has convened a public-stakeholder meeting to discuss CBD and sought input from a wide variety of stakeholders to help FDA make informed decisions. We are also pleased to hear statements from FDA leadership that recognizes Congress’s intent to provide a legal pathway for the production and sale of hemp products.”
The letter concludes, “Given the current widespread availability of hemp-based products, and the growing consumer demand for CBD, we believe that a clear and efficient regulatory framework is necessary to support American farmers, small businesses, and consumers. As increasingly more states legalize marijuana and Federal law recognizes the growth and production of hemp and hemp-derived compound, it is imperative that agencies provide guidance and reduce barriers for small firms looking to enter this rapidly evolving industry.”
The full text of the letter can be found below:
The Honorable Alex Azar
Secretary
Department of Health & Human Services
200 Independence Ave, SW
Washington, DC 20201
The Honorable Ned Sharpless
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Dear Secretary Azar and Acting Commissioner Sharpless,
As Members of the House Committee on Small Business, we appreciate the opportunity to provide comments to the Food and Drug Administration (FDA) on products containing cannabis or cannabis-derived compounds. Farmers, entrepreneurs, and small businesses around the country are ready to engage in this new industry that will create jobs and spur economic growth.
When the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) was signed into law on December 20, 2018, Congress legalized hemp and recognized the legality of certain cannabis-derived products such as cannabidiol (CBD). Specifically, the law also authorized the production, transportation, and sale of hemp and hemp-based products across the United States and removed hemp from the Controlled Substances Act (21 U.S.C. 802(16)).
The passing of the 2018 Farm Bill ushered in the potential for a new agricultural industry that will impact textiles, paper, pharmaceuticals, dietary supplements, and countless other consumer products. Since small businesses comprise over 99 percent of all employers in the United States, the legal cannabis industry provides an opportunity for small firms to lead the way by fueling local economies and creating new jobs.
Congress has been clear in legalizing the growth and production of hemp and hemp-derived compounds. Farmers around the country are eager to adopt a new exciting crop and are enthusiastically awaiting the establishment of a regulatory framework from the United States Department of Agriculture (USDA). Businesses are ready to capitalize on the growing consumer demand for hemp and hemp-derived products, such as cannabidiol (CBD), yet the FDA’s lack of clarity has caused confusion for farmers, businesses, and consumers. We are pleased that in recent months, FDA has convened a public-stakeholder meeting to discuss CBD and sought input from a wide variety of stakeholders to help FDA make informed decisions. We are also pleased to hear statements from FDA leadership that recognizes Congress’s intent to provide a legal pathway for the production and sale of hemp products.
However, regulatory uncertainty is currently stifling the potential growth of hemp businesses. The FDA has made clear that under the current interpretations of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), businesses are prohibited from introducing food products or dietary supplements containing CBD into interstate commerce. The FDA has taken the position that CBD is a drug and not a dietary supplement because of previously authorized studies and approval of the drug Epidiolex, which contains 98% CBD. However, lower concentrated CBD products can be found across the country – in coffee shops, cocktail bars, restaurants, grocery stores, gas stations, massage parlors, fitness centers, pet stores, and health stores. This business development has occurred largely outside of any well-defined or strictly enforced regulatory regime.
The FDA has existing statutory authority under 21 U.S.C. 321(ff)(3(B) and 331 (ll)(2) to issue a regulation that would allow these legally hemp-derived products to lawfully enter the marketplace as a food or dietary supplement, and we urge the FDA to do so. Regulations are needed to address the production, sale, quality, testing, labeling, and marketing hemp-derived products such as CBD. Businesses making unfounded health claims, not otherwise permitted for food or dietary supplements, should certainly not be making these claims about hemp-derived products, and we appreciate the work that the FDA has done to address these issues in the marketplace. But more work is needed. This retail market is far too large to remain unregulated, and the lack of clear regulation can cause a variety of problems around product quality, safety, production, distribution and sales of CBD.
We appreciate the FDA’s commitment to the health and well-being of our country and our communities, and fully expect the agency to review a number of health and safety considerations around the production and use of CBD. However, the FDA’s indication of a multi-year regulatory process will continue to allow space for bad actors in this industry. Businesses need clear and prompt regulations to standardize the growth, production, quality, manufacturing, testing, marketing, and sales of CBD products. We urge the FDA to take prompt and clear regulatory action to clarify the federal rules around the production, sales, and marketing of CBD to support American farmers and entrepreneurs in this growing market, while at the same time providing assurance to consumers that products are not misleading, mislabeled, and are produced using good manufacturing practices. Now is the time for the FDA to craft benchmark safety and quality standards for the production of hemp-derived products in order to increase consumer satisfaction and confidence as this nascent industry transitions and matures into a legal marketplace.
Therefore, we urge FDA to issue straightforward enforcement guidance no later than September 30, 2019 so that businesses around the country are provided with clarity and understanding. Additionally, the FDA should promptly issue an interim final rule, to ensure a regulatory pathway through a permanent final rule, for the use of legally produced CBD as a food additive and a dietary supplement ingredient. We also encourage the agency to initiate rulemaking on the manufacturing, marketing, and sale of products containing hemp product and derivatives, included CBD, under existing statutory and regulatory frameworks.
Given the current widespread availability of hemp-based products, and the growing consumer demand for CBD, we believe that a clear and efficient regulatory framework is necessary to support American farmers, small businesses, and consumers. As increasingly more states legalize marijuana and Federal law recognizes the growth and production of hemp and hemp-derived compounds, it is imperative that agencies provide guidance and reduce barriers for small firms looking to enter this rapidly evolving industry.
We appreciate the opportunity to provide comments and look forward to collaborating on this very important industry.
Sincerely,
