The FDA is signaling a change in how supplements are regulated that threatens not just hemp oil, but the entire industry.
The FDA recently rejected two “new supplement” notifications for full spectrum hemp oil products. Previously the agency targeted CBD oil, stating that CBD is not a dietary supplement. These new actions are extremely concerning since they indicate that the FDA will block other hemp products from the market in addition to CBD. Even more concerning is a shift in the agency’s thinking about the safety standard required for “new supplements” that threatens access to thousands of products. We need Congress to support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
The FDA’s actions against CBD, a beneficial compound found in the hemp plant, are an effort to protect drug industry monopolies. Recall that CBD was approved as a drug for a rare form of epilepsy and costs a reported $32,500 a year. CBD and hemp are helpful for a variety of conditions, including pain, anxiety, depression, and even heart disease. The FDA doesn’t want consumers to be able to buy cheap CBD supplements when they can spend thousands on the drug.
Full spectrum hemp oil is an extract of the hemp plant that contains CBD and a host of other beneficial compounds. We reported previously that while the agency was targeting CBD products, the status of hemp oil was unclear. It is discouraging, but not all that surprising, that the FDA is also now blocking the path forward for affordable hemp oil dietary supplements.
How did we get here? Congress legalized hemp at the federal level but preserved the authority of the FDA to regulate products within its jurisdiction that contain hemp, including supplements, cosmetics, and food. The FDA’s current position on the legality of using hemp or CBD in these various products can be found here.
The most concerning aspect of these new actions is the specific language used by the FDA in the rejection of the “new supplement” notifications for hemp oil. By law, any dietary supplement introduced to the market in the US after 1994 is considered “new” and the manufacturer must provide data to the FDA indicating that the “new supplement” can “reasonably expected to be safe.” But in the rejection letters to the marketers of hemp oil, the FDA has applied a different, more stringent safety standard for “new supplements,” requiring that companies now prove there is “reasonable certainty of no harm.” This standard is from an earlier version of the “new supplement” guidance document from 2011—a version which ANH-USA and other stakeholders successfully pushed back against until the FDA withdrew it. The agency then released a new version in 2016 that amended the safety standard called for in the 2011 guidance. Both versions of the guidance are deeply flawed and threaten thousands of supplements—but applying the old safety standard makes it even harder to comply with these requirements.
Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.
It is deeply troubling that after years of inaction, the FDA is reverting back to a standard that will make it more difficult for hemp oil and tens of thousands of other beneficial supplements to reach consumers.