Time for a New FDA Regulatory Category?

U.S. Food and Drug Administration (FDA)

Cannabinoid products are on a collision course with FDA’s single-molecule fetish. The Cannabis industry strives for robust “full spectrum” and “broad spectrum” poly-cannabinoid profiles, FDA wants only one active ingredient, two at most. The only solution is to define this new class of Cannabis products as a new category.

Time for a New FDA Regulatory Category?

There is precedent for the same substance to be a food, a dietary supplement, a medicine, and also a medical device. It depends on form, process, and concentration. Popular and efficacious “full spectrum” Cannabis tinctures and extracts produced by some of today’s drug companies and sold by pharmacists (patent medicines) pre-date FDA by 100 years.

“For example, garlic could be a food if you put it on pizza, a food additive when added as a powder, a drug when used for cholesterol control, or a device if inserted into the ear to prevent swimmer’s ear,” said Dr. Hoffman. “And then what happens if you extract components from the garlic and bottle that as a distinct product?”

Doterra's FDA Claims Guide
Doterra’s FDA Claims Guide

The current regulatory framework recognizes the following different types of claims:

Drug claims: for controlled substances prescribed by healthcare professionals and used to treat a specific disease state.

Over-the-Counter Drug or Supplement claims: for products generally considered safe and with efficacy in treatment of minor ailments or physiologic states. My HempNut Hempeh Burger sported a legal health claim, that it reduced the risk of heart disease. That wasn’t thanks to the hempseed, but the soybean. At the time (1995-2002) foods with more than 7 grams of soy protein per serving could make that claim, and it was 90% marinated tempeh, 10% HempNut shelled hempseed. It was the first and only hemp food to ever make a legal health claim.

Hempeh Burger, first legal health claim

Medicinal Food claims: used in the marketing of specialty food items to meet specific dietary needs.

Blue Corn Chips

Structure/Function claims: widely used by the supplement industry for products which affect a particular physical structure or bodily function. Structure/Function claims can posit “well-being,” but cannot state benefits in treating disease. HempNut Blue Corn Chips, HempNut Hempseed Oil, and HempNut shelled hempseed had legal Structure/Function claims, for “omega-3 supports a healthy heart, brain, and immune system. This product contains XX mg omega-3.”

Nutrient claims: seen most commonly with meal replacement products.

Click here to read more about this at Holistic Primary Care magazine.

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