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FDA Rejects Group’s Petition to Further Restrict Marijuana

FDA Cannabis

Drug Watch International filed a petition with the FDA to request a nationwide crackdown on marijuana. That request was denied. The anti-marijuana organization says that marijuana and its derivatives are not “generally recognized as safe and effective.”

The FDA’s Center for Drug Evaluation said that the crackdown is “not necessary for the protection of public health,” Forbes reports. The FDA heard many pleas from the prohibitionist group claiming that marijuana doesn’t have any medicinal uses. The FDA already has the power to remove unapproved drugs that may contain marijuana, its derivatives or THC from the market.

Drug Watch International, regarding approval of their request, that, “It would immediately make such claims unlawful and subject the sponsors of regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions permitted under the [Food, Drug and Cosmetic Act].”

The FDA’s rejection of this request affirms that the Trump administration isn’t attempting to bring down the legal marijuana industry.

The FDA also has a negative monograph list which is where the unapproved drug products are listed. This list includes aphrodisiacs, nail-biting deterrents and daytime sedatives. Regarding that list, the FDA says it isn’t “intended to be comprehensive lists of all classes of OTC products, active ingredients, or conditions that cannot be marketed without FDA approval.”

The FDA said, “While you suggest that a negative monograph would reduce or end the unlawful marketing of unapproved new OTC drugs containing marijuana or THC, existing law makes very clear that such unapproved products cannot be marketed under the FD&C Act. FDA has not determined that any OTC drug products containing marijuana or THC are [generally recognized as safe and effective] for their intended indications. Therefore, these products are ‘new drugs’ per section 201 of the FD&C Act that must be approved by FDA to be legally marketed.”

Janet Woodcock, director of the Center for Drug Evaluation and Research, said, “It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law. [A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.”

The rejection by the FDA to include marijuana on the negative monograph list is another positive for the marijuana industry and removes one more roadblock toward the end of federal prohibition.