Congress members demand FDA clarification on CBD

Posted on February 20th, 2019 by Global Ganja Report and tagged , , , , , , , , , .

CBDFollowing the crackdown on CBD-infused foods and beverages by authorities in New York City and elsewhere, Capitol Hill lawmakers are formally calling upon the FDA to provide immediate clarity on the question. Meanwhile, New York, at least is starting to lift the pressure.

Twelve members of Congress on Feb. 15 sent a letter to the Food and Drug Administration, calling for “immediate leadership” on CBD in foods, drugs and cosmetics. However unrealistically, the letter requests a response from the FDA by this Friday—one week after the letter was sent.

First released to the public Feb. 20 and addressed to FDA commissioner Scott Gottlieb, the letter notes the current crackdown on CBD-infused food in New York City, Maine and Ohio. The lead signatory is Maine's Rep. Chellie Pingree, followed by Jared Golden, also a Democrat from the Pine Tree state.

The letter states that the crackdowns have “spurred a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of these products." The lawmakers charge that the FDA's silence has resulted in the current "patchwork of state regulations" that is hurting businesses.

"As you know, hemp is a growing market for farmers and communities across the country," the letter reads. "Last December, the President signed the Agricultural Improvement Act of 2018 into law, which removed hemp from the list of Schedule I Controlled Substances. Following the President's signing of the farm bill, you released a statement clarifying FDA's role in the regulation of hemp-derived CBD products. In this statement, you committed to holding a public meeting on this topic to gather information. Additionally, you mentioned that FDA approved Generally Recognized As Safe (GRAS) designation for three hemp-derived ingredients: hulled hemp seeds, hemp seed protein, and hemp seed oil." 

In light of this, the letter calls on the FDA to "swiftly provide guidance on lawful pathways for food products with CBD," suggesting that GRAS designation could be appropriate here as well. It queries whether the FDA has "advised" those jurisdictions that have initiated the crackdowns. Finally, the letter presses Gottlieb on the public hearing promised after the signing of the farm bill in December to air the question.

Somewhat presumptuously, the letter calls for Gottlieb to respond "by February 22, 2019." 

Hemp Industry Daily in its report on release of the letter, says that it reached out to the FDA, but that a representative for the agency declined to comment, saying the agency would respond to Congress directly. The spokesperson did not  say if the response would come by Feb. 22.

Reprieve in New York City
Meanwhile, authorities in New York have started to relax enforcement—at least tentatively. The city Department of Health has issued new guidelines, putting off its "embargo" of CBD-infused food and drink.

Crain's New York Business reports that businesses not in compliance will now have their products embargoed beginning July 1. Said products will have to be returned to the supplier or discarded. Businesses still not in compliance by Oct. 1 may face fines of between $200 and $650, as well as "violation points" that count toward the "letter grade" issued by the Health Department for city eateries.

The new guidance was issued following requests for clarity by many in the restaurant industry, including the New York City Hospitality Alliance.

"This comes after multiple inquiries about its use went unanswered and DOH issued violations to businesses and embargoed products containing CBD," the Hospitality Alliance said in a statement after the guidance was issued. "DOH will not embargo products or issue violations for CBD until later this year, which is the education-first, fine-last regulatory approach we've requested."

The statement said the Health Department will rescind any violations already issued against city eateries.

Before the July and October deadlines, the FDA may provide legal clarity on the question. Otherwise, the issue could heat up again in Gotham. City Council Speaker Corey Johnson last week stated that he thinks the DoH overreacted, and warned: "I want to hear what the Health Department wants to do to correct this given the science, and if they refuse to do so, the Council is willing to look at this issue legislatively."

At the moment, the FDA's Marijuana Questions and Answers page only states that CBD as a food additive or dietary supplement is not legal.

Cross-post to Cannabis Now 


Image: World of Molecules



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