Tuesday 19 September 2017

Marijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?

Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed in to ask what the FDA position was and if foods, dietary supplements or drugs could contain cannabis. The short answer is no. For federal purposes marijuana remains a schedule I controlled substance deemed to have no medicinal value. The decriminalization either fully or for medical applications by states has not changed the status.

THC has a limited application as an FDA-Approved medication in clinical trials. In clinical trials it was shown to have a therapeutic benefit for relieving nausea associated with cancer chemotherapy and stimulating appetite in patients with wasting syndrome (severe weight loss) that often accompanies AIDS. To date the evidence from the clinical trials falls short of the standard needed for the marijuana plant to gain FDA approval. There are a number of reasons why the US FDA has withheld approval.  The National Institute of Drug Abuse lists those reasons:

First, there have not been enough clinical trials showing that marijuana’s benefits outweigh its risks in patients with the symptoms it is meant to treat. The FDA requires carefully conducted studies in large numbers of patients (hundreds to thousands) to accurately assess the benefits and risks of a potential medication.

Second, to be considered a legitimate medicine, a substance must have well-defined and measurable ingredients that are consistent from one unit (such as a pill or injection) to the next. This consistency allows doctors to determine the dose and frequency.

Finally, marijuana has certain adverse health effects that also must be taken into account. Because it is usually smoked, marijuana can cause or worsen respiratory symptoms (e.g., bronchitis, chronic cough). It also impairs short-term memory and motor coordination; slows reaction time; alters mood, judgment, and decision-making; and in some people can cause severe anxiety (paranoia) or psychosis (loss of touch with reality). And marijuana is addictive—about 4.5 million people in this country meet clinical criteria for marijuana abuse or dependence.

Thus, any food or dietary supplement containing THC is prohibited. Additionally, any food or dietary supplement implying any of the effects of smoking or eating cannabis is prohibited. The FDA has issued several warning letters prohibiting “street drug” claims. It’s also important to remember the Supreme Court upheld the ban of cannabis, even medical uses, in 2005. The decriminalization in Colorado and Washington will likely lead to new legal challenges. Those challenges, however, are unlikely to open-up marijuana sales for inter-state commerce.

If a product contains hemp seed oil or similar hemp byproducts it may be possible to enter the market with a conventional food/drink or dietary supplement provided at a bare minimum the ingredient is Generally Recognized as Safe (GRAS)* and Good Manufacturing Practices (GMPs) ensure THC is not present in the product.

 

*”GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. Under sections 201(s) and 409 of the Act, and FDA’s implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

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