The FDA Issues New Batch of Warnings on CBD Products
Feb. 22nd, 2016
The US Food and Drug Administration(FDA) is at it again- cracking down on “dangerous” drug products such as CBD oil. The FDA issued eight warning letters to companies that market products containing cannabidiol. Any company found guilty of mislabeling CBD or other cannabinoid levels can be shut down by the FDA within two weeks.
The FDA has turned its back on the cannabis industry, claiming that CBD products cannot be sold as dietary supplements.
Companies affected by the latest crackdown include Cali Stores, Dose of Nature, Green Garden Gold, Healthy Hemp Oil, Michigan Herbal Remedies, Morgue Juice, Pain Bomb and Sana Te Premium Oils. According to the FDA’s analysis, all products contained different amounts of Δ9-THC, THCa, CBDa, CBN and CBD than they had claimed.
Two of the affected companies say their products originated from CV Sciences, formerly known as CannaVest. Stuart Tomc, VP of Human Nutrition, says CV Sciences never received any letter;
“FDA routinely sends out warning letters for drug claims, however this issue originated from an FDA Q and A online post about marijuana, not dietary supplements. Notwithstanding the FDA’s Q&A posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, thereby rendering the IND preclusion inapplicable,”
The FDA has denied claims that CBD products are being marketed as supplements. In a Q&A, the FDA wrote “…If a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”
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 FDAwrote “PainBomb violated the FDC 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.
The FDA argues that there’s still not enough research on the medical benefits of CBD. Forget the enormous amount of scholarly articles regarding CBD’s effectiveness against neurological disorders, epilepsy, and HIV.
No comments:
Post a Comment