Although the DEA’s hands are currently tied by the Rohrabacher-Farr Amendment (if only for a couple more months), state-sanctioned medical marijuana marketers and sellers could be in danger of a massive FDA crackdown resulting in millions of dollars in fines and even potential criminal charges.
Although states are quickly rolling out medical marijuana programs, the federal government is not yet on board with marijuana as a medicine. As far as federal law is concerned it’s still a dangerous Schedule 1 drug with no medicinal benefits and a high potential for abuse.
The growing use of medical marijuana products across the country is causing the United States Food and Drug Administration (FDA) to take notice. The agency is becoming wary of the health claims being made by some of the manufacturers of these products, and threatening to enforce federal laws regarding “false” (read: non-FDA approved) claims.
FDA Commissioner Scott Gottlieb recently hinted that the agency might put pressure on marketers and retailers whose health claims cross the line. “I see people who are developing products who are making claims that marijuana has antitumor effects in the setting of cancer,” says Gottlieb.
The Food Drug and Cosmetic Act (FDAC) gives the Food and Drug Administration (FDA) more strict regulatory powers over drugs and health supplements. FDA approval of such products is a vastly time-consuming and expensive undertaking. New drugs must be exhaustively tested by drug marketers in order to receive FDA approval. The process can take many years and cost millions of dollars.
The FDA approval process begins with laboratory and animal tests, then progresses to clinical trials with human patients to ensure the drug is safe and effective in treating a particular disease. The drug producer must submit to the FDA tomes of test results including potential side effects, along with information on how the company will manufacture the drug. If the drug’s benefits prove to outweigh the risks and manufacturing methods are proven to produce consistent products, the drug may be approved. Only then can it be marketed as a legal drug.
This approval process would be extremely difficult to apply to medical marijuana because of the many factors that come into play in the production cycle, many of which will invariably affect the final product.
As far as states with medical marijuana programs are concerned, both THC and CBD extracted from cannabis have been approved for medical uses such as preventing seizure disorders and relieving pain, but until it is confirmed by FDA for medical use, retailers are required by federal law to use “natural supplement” language in their marketing. For example, a label that says “helps improve mood” might be okay, whereas a claim that the product “reduces depression” would be a violation. Claims that a product reduces pain, stops seizures, kills cancer cells, or any of the many other claims of health benefits of medical marijuana are in flagrant violation of federal laws and could result in devastating fines, confiscations, and potentially long and expensive legal battles.
As of now, the FDA has kept its nose out of state-legal medical cannabis, but given the FDA’s renewed sense of duty to examine marijuana medical claims, a very costly FDA intervention may be looming on the horizon.
This article was originally written for and appeared in World Medical Cannabis Conference and Expo newsletter.