Call Us Toll Free (800) 688-5956

State hemp and CBD is still not easy to navigate

As FDA continues to contemplate potential regulatory pathways for hemp-derived CBD, an increasing number of states are moving forward with their own laws and policies aimed at regulating this popular product category, especially in the dietary supplement and food space.

Several states are imposing robust testing, labeling and registration requirements for these products—with more likely to follow—or restricting the sale of hemp and CBD-containing food and dietary supplements altogether, citing concerns about the absence of federal oversight.

Unfortunately for companies operating in this space, not all these state mandates are similar. Coupled with THC testing issues, many companies are faced with logistical challenges and supply chain headaches when it comes to navigating the various state regulations (and risks) for CBD and hemp products.

In addition to legalizing hemp and its derivatives, such as CBD, the legislation also directs USDA to create a regulatory framework for approving state-developed hemp plans as well as a federal plan for states that choose not to have primary oversight for the regulation of hemp.

Many states are currently in the process of developing hemp plans, which are primarily focused on the cultivation of hemp and related issues such as licensing hemp growers and THC testing. At the same time, they are also taking the opportunity to place restrictions or limits on the manufacture and distribution of finished products.

Read The Full Article HERE

Hemp and CBD reportedly will be officially legalized in Farm Bill

cannabis

Although the Congressional committee reconciling competing U.S. Senate and House versions of the Farm Bill are tight-lipped about the exact language that’s been agreed upon, it sounds like the bill, now expected to be signed next week, will legalize industrial hemp.

That spells good news for purveyors of hemp-derived CBD.

Senate Majority Leader Mitch McConnell (R-KY), who made sure he sat on the Congressional reconciliation committee, tweeted that CBD will continue its extraordinary trajectory.

“Thanks for your hard work, @SenPatRoberts,” tweeted McConnell, “for our farmers, rural communities and all Americans. Pleased that my provision to legalize industrial hemp is included in the Farm Bill.”

This was confirmed by two other reconciliation committee members, Rep. Mike Conaway (R-TX) and Rep. Collin Peterson (D-MN), according to a Bloomberg Government reporter, also on Twitter.

The hemp provision reportedly will remove hemp from the federal list of controlled substances, and hemp farmers will be able to apply for crop insurance. Hemp must contain less than 0.3 percent THC. The bill would push hemp regulations both to the U.S. Department of Agriculture and not the Department of Justice as well as to individual states to decide whether or not they want to go forward with commercializing hemp and hemp products including CBD. States can either develop their own plans or just abide by federal regulations that are to be developed by the USDA.

Farmers in the U.S. have planted more than 77,000 acres in 2018, according to Vote Hemp, about three times the amount grown in 2017.

The farm bill removes CBD from the Controlled Substances Act, thereby removing the DEA from enforcing – mistakenly or not – CBD products. However, the farm bill does not change requirements of the Federal Food, Drug, and Cosmetic Act, which means CBD is still subject to FDA regulations. Keeping the FDA involved – outside of its role as regulator of dietary supplements – still maintains an element of risk to CBD businesses.

Read The Full Article HERE

California joins FDA in saying no to CBD in foods, supplements

CBD-oil

A position adopted by state officials in California has drawn criticism from companies selling cannabidiol (CBD) in conventional foods and dietary supplements.

The fresh feud brewing in The Golden State symbolizes the disparate treatment of myriad cannabis products in one of the world’s largest economies. Consumers in California can legally buy marijuana for medical and recreational use, but state officials recently said CBD products are off-limits in foods and supplements.

Relying on statements by the federal agency responsible for regulating food in interstate commerce, the Food and Drug Branch of the California Department of Public Health (CDPH) asserted in a public statement, or FAQ, “[T]he use of industrial hemp as a source of CBD to be added to food products is prohibited.”

“Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive or dietary supplement,” the state agency concluded.

According to CDPH’s statement, “California incorporates federal law regarding food additives, dietary use products, food labeling and good manufacturing practices for food.” The CDPH described CBD as “an unapproved food additive” that is not permitted “for use in human and animal foods per the FDA, and thus, it is not approved in California.”

Asked for this article to explain what prompted CDPH to issue the FAQ, the agency noted, “There has been some confusion on the legal use of CBD and CBD oil since the legalization of medicinal and adult-use cannabis in California.”

In 1996, California became the first state to legalize medicinal marijuana through Proposition 215. Earlier this year, the state began permitting recreational sales of cannabis after California, Massachusetts and Nevada in 2016 joined four other states in legalizing recreational marijuana.

Read The Full Article HERE

FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

02_12_CBD_FDA_Regulating

FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

Read The Full Article Here

ncl-made-in-usa
ncl-fda
ncl-gmp-certified

For more information call (800) 688-5956 or Contact Us for a Free Quote!

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!