Cannabis companies who claim that their products shrink tumors or perform other miracles have never been very popular with the Food and Drug Administration (FDA), which often sends producers letters to warn them that they can’t make unproven health claims.
But in a move that suggests more leneincy than is typical of the federal government’s attitude toward marijuana, the FDA is declining a prohibitionist group’s request to include cannabis in the agency’s list of over-the-counter drugs that it says are not generally recognized as safe or effective.
Any drug manufacturer that makes the FDA’s list, officially called a “negative monograph,” is legally prohibited from marketing over-the-counter drugs without prior approval by the FDA. Drugs currently on the list include over-the-counter daytime sedatives and some herbal medicine, but cannabis appears to be safe from that negative distinction for now.
Drug Watch International, a group that warns consumers about side effects caused by traditional pharmaceuticals but is also opposed to marijuana legalization, sent a petition to the FDA last year urging the agency to give cannabis a negative monograph.
Doing so could allow regulators to “immediately make such [health] claims unlawful and subject the sponsors to regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions,” the group said.
Such a proposal could also have had frightening consequences for people in the medical cannabis industry. While anecdotal stories suggesting that cannabis can help cure everything from opioid addiction to depression are widespread, federal limitations on studying marijuana make such claims extremely difficult to prove.
That can put companies marketing to people seeking cannabis as medicine in a difficult position as they try to advertise their products.
But in a recent decision, the FDA told Drug Watch International that it was denying its request to reclassify cannabis or launch a tougher crackdown on misleading labels. Forbes magazine is reporting that the agency sent a letter to Drug Watch International on Monday stating that such a measure would essentially be overkill.
Such enforcement is "not necessary for the protection of public health," Janet Woodcock, the director of FDA's Center for Drug Evaluation, reportedly told the group last week.
Not lifting scrutiny entirely
It’s not that the FDA plans to stop investigating cannabis companies and their marketing labels. Woodcock added in her letter that the FDA will continue to take “enforcement action against illegal marketing of unapproved” cannabis products, but that classifying cannabis as a dangerous substance simply isn’t necessary to do so.
In addition to targeting cannabis companies with bombastic health labels, the FDA is also sending warning letters to companies that advertise cannabis products as dietary supplements and who market their products online.
According to the FDA, selling cannabis products to consumers across the country is a violation of federal laws that prohibit “interstate commerce without prior approval from the FDA.”
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