10.23.19

SCHUMER REVEALS: STALLED FED GUIDANCE & UNANSWERED QUESTIONS ON CBD HAS UPSTATE HEMP FARMERS MISSING OUT ON BUDDING INDUSTRY; SENATOR CALLS ON FDA TO CLARIFY & IMPLEMENT CBD REGS ASAP TO SPUR GROWTH OF NEW JOB-CREATING INDUSTRY UPSTATE AND PROTECT CONSUMERS

The Passage of Schumer’s Provision In 2018 Farm Bill Caused Explosion Of Hemp Growing & Processing But FDA Regs Still Lag For CBD

Schumer Demands Clarity, Guidance & Timeline; Calls On FDA To Expediently Set Guidance On Labeling, Producing, Marketing & Selling Of Products Containing CBD

Schumer To FDA: Clarify CBD Regs To Safely Unleash Emerging Industry Upstate And Protect Consumers

On a conference call with reporters and in the midst of an industrial hemp explosion across Upstate New York—triggered by a Schumer-championed provision in the recently passed Farm Bill—U.S. Senator Charles E. Schumer today urged the Food and Drug Administration (FDA) to issue guidance and allow producers to fully take advantage of the popular cannabidiol (CBD) market and also protect consumers.

 Even though CBD products have gained popularity since the 2018 Farm Bill legalized the farming, manufacturing, and selling of industrial hemp, Schumer explained that the FDA has yet to set regulations or safety requirements for CBD derived from hemp. According to Schumer, the lack of federal guidance and clarity is sowing chaos for both consumers and in the rapidly-emerging Upstate New York industrial hemp industry, which saw sales of CBD products surpass $200 million nationally in 2018. To address this lack of clarity, to protect consumers, and to allow the industrial hemp industry to maximize job creation from this cash crop, Schumer urged the FDA to expediently issue guidance on the classification, labeling, quality, marketing, and sale of CBD products.

“CBD is brimming with potential to be a billion dollar industry across New York State, bringing along countless jobs and truly meaningful economic development with it. But before that can happen, farmers, growers, producers, consumers and vendors need to know exactly what the rules of the road are and right now they’ve got no idea,” said Senator Schumer. “That’s why I’m calling on the FDA to do its job in a timely manner and issue guidance related to CBD classification, labeling, quality, marketing, and sales. And once the feds spell out these ABC’s of CBD, the industry will seed and grow from one corner of the state to the other, many jobs will be created in the industrial hemp space, and farmers will be able to safely cash in on this cash crop.”

CBD is one of the two main chemical compounds that can be found in the cannabis plant. However, CBD is not psychoactive, meaning that it cannot get a person high—like tetrahydrocannabinol (THC), the other chemical compound found in many types of cannabis plants, primarily marijuana. CBD products have become exceptionally popular in the marketplace, with estimated sales of CBD-containing products, such as oils, gummies, balms, lotions, and capsules, surpassing $200 million in 2018.

According to the New York State Department of Agriculture and Markets, there are currently just under 500 people, businesses, and organizations spread across New York State licensed to grow and process industrial hemp. According to news reports, roughly three-quarters of those licenses were approved for the purposes of cultivating and extracting CBD. Currently, there are 18,000 acres of land licensed for industrial hemp growing in New York State, with 14,000 designated for CBD cultivation and extraction. Furthermore, of New York’s 62 counties, 56 are home to industrial hemp farms and related growing operations. Schumer explained that these figures show just how much potential CBD products have to boost the economy across New York State, should clear guidance on CBD be issued by the FDA.

Schumer explained that the FDA is responsible for protecting public health, and guidance related to CBD is desperately needed to ensure that products on the market are safe. He also said that consumers rely on the FDA to conduct timely and appropriate oversight of new and emerging ingredients, like CBD, and that guidance from the agency would provide crucial direction for manufacturers seeking a pathway to develop safe and credible products for consumers.

Schumer argued that the market for CBD products is rapidly growing and that the agency must expedite its efforts to promote accuracy and transparency within the CBD industry. Specifically, Schumer called on the FDA to provide an outline of its plans for a regulatory framework related to CBD, as well as a timeline for when comprehensive enforcement policies for CBD products will be finalized and implemented.

The Schumer-backed Hemp Farming Act of 2018 was introduced by Majority Leader Mitch McConnell (R-KY), Sens. Rand Paul (R-KY), Jeff Merkley (D-OR), and Ron Wyden (D-OR). It passed and was signed into law as part of the 2018 Farm Bill. This legislation: 

  • Removes industrial hemp from Schedule 1 of the Controlled Substances Act
  • Empowers states to be the principal regulators of hemp
  • Allows hemp researchers to apply for competitive federal grants from the U.S. Department of Agriculture (USDA); and
  • Makes hemp farmers eligible to apply for crop insurance

Industrial hemp is a type of cannabis plant that is grown largely for industrial uses, but it can also be utilized for food, oil, and cosmetic products. Hemp contains a very small amount of THC, typically between 0.2 and 0.3 percent on a dry weight basis, and while from the same species of plant as marijuana, the two plants have varied widely in use. However, due to the existence of THC in hemp, Schumer explained, both plants were considered “controlled substances” under federal law, meaning the U.S. Drug Enforcement Administration (DEA) was the primary regulator for hemp production. Schumer argued that this narrow view has undermined the crop’s agricultural and economic potential. With the Hemp Farming Act of 2018 passed by Congress and signed into law last year, this unnecessary roadblock has been lifted, and industrial hemp’s significant potential to become a cash crop in Upstate New York’s will be unleashed. 

Dear Acting Commissioner Sharpless:

We write today to ask that the U.S. Food and Drug Administration (FDA) urgently clarify and implement regulations for cannabidiol (CBD) derived from hemp. Since the passage of the 2018 Farm Bill (P.L. 115-334), which paved the way for industrial hemp cultivation and marketing, farmers, processors, and retailers across the country are eager to enter this new market and leverage its potential. With new products containing CBD becoming available nearly every day, your agency’s lack of an official stance on this ingredient remains confusing to manufacturers and potentially dangerous to consumers. It is now imperative that the FDA finalize and implement a comprehensive regulatory framework for CBD, including guidance on the classification, labeling, quality, marketing, and sale of CBD-containing products, to ensure each manufacturer is producing safe and effective products for consumers.  In accordance with your agency’s July statement regarding CBD oversight, we expect an update on your activities no later than 90 days from today’s date.

The CBD industry has exploded in recent years. Estimated annual sales of CBD-containing products were over $200 million in 2018, and CBD oils, gummies, balms, lotions, capsules, and other products are broadly available and widely advertised in stores and online. However, as the CBD industry expands, the lack of clarity and regulation around CBD use has created significant confusion and uncertainty among stakeholders in every segment of the supply chain. It is crucial that the FDA remain proactive in its duty to safeguard public health, protect consumers from potentially unsafe products, and provide a predictable pathway to market for producers and manufacturers.

Purveyors of CBD-containing products attribute a wide range of health benefits to this ingredient, including relieving pain and anxiety, preventing seizures, treating post-traumatic stress disorder, and easing inflammation. But consumers still lack answers to questions about the potential risks, including adverse side effects and drug interactions, associated with CBD.

Consumers rely on the FDA to conduct timely and appropriate oversight of new and emerging ingredients, and guidance from the FDA would also help manufacturers to develop safer, more effective, and more credible products for consumer use. The market for CBD products is rapidly outpacing the FDA’s current regulatory efforts, and your agency clearly must expedite its efforts to promote accuracy and transparency within the CBD industry. It is imperative that any comprehensive regulatory framework for products containing CBD provide straightforward guidance to manufacturers and retailers who wish to incorporate CBD into new products.

Consumers and manufacturers of this fledgling industry are counting on regulatory oversight and certainty that only the FDA can provide.  Your efforts to date have been woefully inadequate. Within 90 days please provide our offices with an outline of your agency’s current plans for a specific regulatory framework related to CBD along with a timeline for when comprehensive enforcement policies for CBD products will be finalized and implemented. 

Thank you for your attention to this matter and we look forward to your response.

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