fda outlaws cbd and hemp oil

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

Questions and Answers

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

8. Is it legal for me to sell CBD products?

Regulatory Resources

A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

Fda outlaws cbd and hemp oil

This continues the FDA’s ongoing battle against unapproved CBD products. In April of 2015, the FDA issued six similar warnings to companies with varying amounts of CBD. Pain Bomb, one of the companies in question, was issued an FDA warning February 4th, 2016. Members of the FDA wrote “PainBomb violated the FDC [Food, Drug, and Cosmetic] Act by misbranding its products. The diseases for which PainBomb marketed its products cannot be self-diagnosed or self-treated by people other than health care professionals. For this reason, PainBomb’s instruction labels informing users whether and how to use its products violate the FDC Act.” The Federal Food, Drug and Cosmetic Act, otherwise known as the FDC Act, requires scientific information to demonstrate that a drug is safe. Pain Bomb allegedly violated section 201(g)(1)(B) of the FDC Act [21 U.S.C. § 321(g)(1)(B)]. The FDA gave Pain Bomb only 15 business days to correct all foregoing violations.

Another commonly reproduced bit of verbiage held (without substantiation) that the impetus behind the FDA actions was a drug company’s interest in CBDs:

The FDA hasn’t banned the sale of cannabidiol oils because a drug company is interested in marketing them.

Despite lengthy edits, the article remained factually inaccurate, claiming that the FDA asserted CBD oils were “adulterated products”:

Rating

The term “drug” means … (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals[.]