Alibi V.28 No.30 • July 25-31, 2019 

Baked Goods

CBD Causes Headaches

FDA faces pressure from all sides

Baked Goods logo
Rob M.

The debate over CBD is heating up as advocates on different sides take part in a tug-of-war with the Food and Drug Administration.

Last week, New Mexico Attorney General Hector Balderas joined a coalition of 36 attorneys general from other states in urging the FDA to study the risks involved in using cannabis-derived products like CBD—especially for pregnant women, children and the elderly—before allowing them onto the market.

“We write to express our hope that the FDA continues to explore manufacturing, testing, and marketing best practices so that consumers are not at risk of misleading advertising or harm to their health from dangerous additives or undisclosed risks of use,” wrote the coalition. “A crucial element of FDA regulation and oversight should be an on-going assessment of the potential risks or benefits of these products … How these products interact with other dietary or pharmaceutical products should be included in this assessment. It is also important that companies not mislead consumers. Scientific and medical data from the FDA would assist in meaningful enforcement of advertising laws and regulations by the states.”

The letter was one of thousands submitted to the FDA earlier this month after the agency opened a period of public comment related to CBD regulations. Currently, CBD-infused consumables are banned by the agency, because CBD is the active ingredient in Epidiolex, a pharmaceutical used to treat rare forms of epilepsy in children. The law forbids the use of pharmaceutical drugs in over-the-counter foods and supplements.

In its letter, the Center for Science in the Public Interest similarly wrote, “It is critical that FDA assert its authority on behalf of consumers to ensure that products are safe, accurately labeled, and free of adulterants and contaminants, and that consumers are aware of relevant risks. To do so will require that the agency articulate a long-term program to gradually align the state laws that legalize these products with applicable federal health and safety protections.”

But some of the letters seemed to be urging the FDA to hurry up and regulate. Vote Hemp wrote that the agency should treat whole-plant hemp derivatives in the same manner “as any other herb.” It argued that extracts using an entire plant's profile are different than the CBD-extract used in Epidiolex. Whole-plant hemp extracts … are not pharmaceutical drugs,” the letter said. “Especially when they are not marketed to have a therapeutic effect on consumers.”

The US Hemp Roundtable said they believe that Congress “intended to have CBD and hemp products available to consumers in a wide range of product categories—including food and dietary supplements—when it passed the Agriculture Improvement Act of 2018” and that they also believe “that FDA has all the tools necessary to expeditiously issue a rule allowing CBD in foods and dietary supplements.”

Earlier this month, FDA Acting Chief Information Officer Amy Abernethy tweeted “FDA is expediting its work to address the many questions about cannabidiol (CBD).” In June, the House of Representatives approved a policy amendment that would compel the FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”

DOH Discusses Plant Limits

The New Mexico Department of Health recently held a public hearing on proposed changes to the state's medical cannabis program.

In June, the DOH invited public comment on a proposal to limit the number of plants that licensed producers are allowed to grow to 1,750. This lowered the limit from 2,500—a temporary number set by an emergency rule change in March.

According to a DOH press release, “The Department of Health carefully developed the new plant limit to balance concerns about available medical cannabis supply while limiting the risk of the over-production that has disrupted regulated systems in other states.” In addition to the new limit, the proposed rule change would allow producers to “request an increase of up to 500 permitted plants if they are nearing their capacity to supply their patients’ demand.”

The change might be a decrease from the current emergency rule limit, but it's way higher than the 450-plant limit in place February. According to NM Political Report, the only producer at the meeting who spoke out against the proposed limit was president and CEO of Ultra Health, Duke Rodriguez. An Ultra Health project manager reportedly called the limit “arbitrary,” and Rodriguez suggested a limit of 5,000 plants.

The DOH has until August to come up with a permanent limit.

Strain Corner

This week I dropped by Everest Apothecary (9237 Fourth Street NW) for a gram of Candyland (THC: 24.96%, CBD: 0.77%—$10/gram). It smelled tangy and sour, with a serious bite that almost made me sneeze. The dark and compact bud tasted sweet and flowery.

This sativa-dominant strain brought on an immediate sense of well-being accompanied by a frantic silliness. I felt relaxed and happy, but my mind was going a million miles a second and I had trouble focusing on anything. Candyland is perfect for those suffering from depression and fatigue, but it might be a bit much for those prone to paranoia or anxiety.

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