FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders. Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health and safety risks; manufacturing and product quality; and marketing, labeling, and sales. Here are key
Assembly Bill 228 is a promising piece of legislation that could soon bring an end to California’s prohibition on adding hemp-derived CBD to foods, beverages, and cosmetics. The bill, in its current form, would add two provisions to the California Health and Safety Code clarifying that food, beverages, and cosmetics are “not adulterated by the…
The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) recently updated its guidance on inclusion of hemp ingredients in beverages containing alcohol. Here’s a summary:
• It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the federal Controlled Substances Act.
The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA…
The passage of the 2018 Farm Bill capped off a momentous year for cannabidiol, or CBD, a non-psychoactive derivative of cannabis. As we wrote about here, the year kicked off with the rescission of the Cole Memo, the DOJ’s policy statement regarding enforcement in states where cannabis is legal. The feared enforcement uptick never…
The DEA announced last week that it is placing certain drug products that have been approved by the FDA and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. The action places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.
Earlier this month, the Food and Drug Branch of the California Department of Public Health (CDPH) updated an FAQ document relative to regulation of cannabidiol (CBD), a non-psychoactive derivative of cannabis, which has been in the news most recently relative to FDA’s approval of a CBD drug to treat rare forms of epilepsy. CBD is also widely sold in many states, labeled as a food or dietary supplement.
In the FAQ document, CDPH recited the definition of “food” as
- (a) Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal.
- (b) Any article used or intended for use as a component of any article designated in subdivision (a). [citation omitted]
The CDPH points out that the definition of “food” does not include products containing cannabis, which is legal in California and regulated by the CDPH Manufactured Cannabis Safety Branch. Further, CDPH appears to discard the position held by many in the CBD industry that the 2014 Farm Bill, which legalized growing of industrial hemp by state departments of agriculture or institutions of higher education for research purposes, supports broader legalization of CBD derived from industrial hemp.…
Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level. Under the bill, states would continue to have individual authority to regulate marijuana but federal authorities would be able to prevent trafficking between states where the substance is legal to where it is not and to oversee advertising to the extent necessary to prevent targeting ads to children. Co-sponsors include Senators Bernie Sanders (I-VT), Tim Kaine (D-VA) and Tammy Duckworth (D-IL).
Highlights of the proposed legislation, per the Fact Sheet, include the following:
- Decriminalize Marijuana: The legislation would decriminalize marijuana at the federal level by descheduling it, which means removing marijuana from the list of scheduled substances under the U.S. Controlled Substances Act of 1970;
- Respect States’ Rights: The legislation would maintain federal law enforcement’s authority to prevent marijuana trafficking from states that have legalized marijuana to those that have not;
- Level The Economic Playing Field: The legislation would establish dedicated funding streams to be administered by the Small Business Administration (SBA) for women and minority-owned marijuana businesses that would be determinant on a reasonable estimate of the total amount of revenue generated by the marijuana industry;
- Ensure Public Safety: The legislation would authorize $250 million over five years for targeted investments in highway safety research to ensure federal agencies have the resources they need to assess the pitfalls of driving under the influence of THC and develop technology to reliably measure impairment;
- Invest In Public Health: The legislation would invest $500 million across five years for the Secretary of Health and Human Services to work in close coordination with the Director of National Institutes of Health (NIH) and the Commissioner of Food and Drug Administration (FDA) in order to better understand the impact of marijuana, including the effects of THC on the human brain and the efficacy of marijuana as a treatment for specific ailments;
- Protect Children: The legislation would maintain the Department of Treasury’s authority to regulate marijuana advertising in the same way it does tobacco advertising to ensure the marijuana businesses aren’t allowed to target children in their advertisements. The bill also allows the agency to impose penalties in the case of violations;
- Incentive sealing and Expungement programs: The legislation authorizes grant programs to encourage state and local governments to administer, adopt, or enhance expungement or sealing programs for marijuana possession convictions. The bill provides $100 million over five years to the DOJ to carry out this purpose.
Earlier this week, U.S. Senators Cory Gardner (R-Colo.) and Elizabeth Warren (D-Mass.) and U.S. Representatives David Joyce (R-Ohio) and Earl Blumenauer (D-Ore.) introduced the bicameral, bipartisan Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act). The purpose of the proposed Act is to protect the rights of individual states, the District of Columbia, U.S.…
On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention. The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals. The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found in cannabis that is not considered psychoactive. If approved, Epidiolex would have orphan drug status, meaning that it is marketed to treat rare diseases or conditions, in this instance rare forms of epilepsy. FDA is not bound by the advisory committee recommendations, but often follows them.
With Epidiolex’s approval likely looming, one question is what the impact will be on the CBD dietary supplements currently on the market. FDA has made clear that it does not believe that CBD can be legally marketed as a dietary supplement because of GW Pharmaceuticals’ initiation of investigational new drug applications for its products prior to CBD being marketed as a supplement. Further, FDA has issued numerous warning letters relative to CBD labeled as dietary supplements but that contain little or no actual CBD as well as those that feature express disease treatment claims. Will the approval of Epidiolex impact those CBD products currently sold as supplements? …