Vermont Secretary of Agriculture Writes FDA Requesting CBD Reclassification
After a tumultuous week when Maine and New York state regulators both unexpectedly and abruptly banned the sale of CBD to the public citing, the Vermont Secretary of Agriculture, Foods, and Markets, Anson Tebbetts, issued a letter to the Commissioner of the Federal Food and Drug Administration (FDA).
The response comes amid existential concern from Vermont’s exploding hemp and CBD community upon seeing two fellow northeast states with less hemp cultivation and CBD product sales than Vermont.
In the letter, dated February 7, 2019, Secretary Tebbetts cited the impact upon Vermont’s rural agricultural economy and pointed to the 2018 Vermont Hemp Registry, which included 461 registered growers — the vast majority of which are under 10 acres each — with over 3,200 total acres registered.
According to the letter, interest in Hemp and CBD in Vermont is on track to surpass the 400% growth in 2018 and over 200 applicants registering over of 2,000 acres to grow hemp already in 2019.
The letter distinguishes the pharmaceutically-produced CBD isolate requests a review of the FDA
Read the full text of the letter below:
February 7, 2019
The Honorable Scott Gottlieb, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Dear Commissioner Gottlieb,
The Vermont Agency of Agriculture, Food & Markets (the Agency) requests that Food and Drug Administration (FDA) review its exclusion of hemp–derived cannabidiol (CBD) products from the definition of a dietary supplement for several reasons.
Hemp–derived CBD–products have been used as a dietary supplement prior to the public disclosure of the ‘investigational new drug‘ application for the CBD isolate. The Agency believes that a prior market for hemp derived–CBD products cannot be well–documented as a result of its legal status under previous Farm Bills. However, anecdotally, and a multitude of stories on the internet, indicate that CBD had been used, and sold, whether legal or not at the time, by members of the public for relief of minor pains and calming effects.
Secondly, the derived products from raw hemp extracts, contain other botanicals, cannabinoids and amino acids, which differ significantly from the pharmaceutically–produced CBD isolate.
We respectfully request, the FDA use the Secretary‘s discretion to pursue a pathway to introduce these products into interstate commerce, as we believe they are substantially different from the new drug investigation. The pathway include allowing the hemp industry to market food as containing hemp derived CBD products for non–listed medical conditions for use by the public.
As background, any decisions made by the FDA related to this issue, will have a significant impact on Vermont‘s small, rural, agricultural economy. The Agency initiated its Hemp Pilot Program fully in July of 2018. In that time, the Agency registered 461 growers, with over 3,200 acres registered. This burgeoning agricultural commodity is critical to our state, as the primary agricultural business, dairy, decreased significantly in the same time period as farmers struggle to compete in the fluid milk market.
For 2019, to date, about 200 applicants want to register in excess of 2,000 acres to grow hemp, and many are first time or younger farmers, which we are hoping to revive and keep alive our working landscape.
While the State of Vermont may not be able to compete with other states on the quantity of hemp produced within its boundaries it will, as proven with other Vermont agricultural products like maple syrup and dairy, be able to compete with the rest of the nation on producing quality hemp and cannabinoid products derived from hemp. In order to do this, we need a clear path from the FDA that allows our producers to continue to produce and sell dietary supplements or nutraceutical products and offer them into interstate commerce.
Secretary Agency of Agriculture, Food and Markets
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Heady Vermont will continue to closely track CBD and hemp updates and will be at the UVM Industrial Hemp Conference on Friday, February 8, 2019 and will host the third annual Vermont Hemp Fest at Burke Mountain Hotel and Conference Center on September 7, 2019.