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Will FDA Target Hemp Oil?

Will FDA Target Hemp Oil?
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An update on the fight to protect CBD and hemp. Action Alert!

ANH-USA has been keeping a close watch as the FDA determines how it will treat hemp products. We’ve noted that the FDA has targeted CBD oil, a natural compound found in hemp that is now approved as a drug. But many other products could fall in the FDA’s net, including full-spectrum hemp oil, depending on how the agency decides to move forward. Luckily there is now a bill that would protect hemp-derived CBD from the FDA. Natural health advocates must come out in support of this important measure.

The bill is simple. It amends the law to provide an exemption for hemp-derived CBD and any “hemp-derived CBD-containing substance” from rules that apply to dietary supplements when there is an approved drug with that ingredient or if that ingredient is being investigated as a new drug. If approved as is, this bill would allow hemp-derived CBD supplements and hemp oils containing CBD to be sold.

Note that the other provisions of the Dietary Supplement Health and Education Act of 1994 still apply to CBD. Given that the FDA’s position seems to be that CBD is a “new supplement” (in FDA lingo, a new dietary ingredient, or NDI), this means that before companies sell CBD they will need to submit information to the FDA demonstrating that the CBD supplement can be reasonably expected to be safe.

With the explosion of the CBD and hemp market, and the recent legal changes following the 2018 Farm Bill, there is a lot of confusion about what currently is and isn’t legal. This confusion underscores the need to support this bill, so it isn’t left to the FDA to decide.

As it currently stands, the Farm Bill legalized hemp and its derivatives at the federal level, removing hemp’s classification as a controlled substance. Hemp is defined in the law as a cannabis plant and its derivates containing less than 0.3 percent THC, the psychoactive compound that causes a “high.” This means that hemp-derived CBD is no longer considered a controlled substance, while marijuana-derived CBD remains a controlled substance.

Additionally, the Senate Appropriations Committee approved language directing the FDA to issue a policy of enforcement discretion for hemp-derived CBD products.

In legalizing hemp and its derivates at the federal level, however, the Farm Bill also preserved the authority of the FDA to regulate products that contain hemp, whether it’s food, drinks, supplements, cosmetics, oils, lotions, or any number of products that have come to the market in recent years. In short, while the federal government loosened the reigns on hemp and hemp-derived CBD, all relevant FDA rules still apply to those products.

This is further complicated by the fact that the FDA approved a CBD drug. According to FDA rules, this means that CBD cannot be a supplement; nor can CBD be added to food. This has to do with the FDA back-channel we’ve discussed previously: if the FDA decides that clinical drug investigations on a compound began before that compound was marketed as a food or supplement, then that compound cannot be sold in supplements.

The FDA has affirmed the illegality of CBD as a supplement in the warning letters it has been sending out to CBD and hemp companies, though the agency seems to be focusing its enforcement on companies making health claims about CBD and hemp. The FDA’s stance has led to lawsuits in California against CBD companies for misleading consumers by marketing CBD products as supplements when FDA specifically said this was illegal.

But what does all of this mean for hemp oil? It depends. The FDA has said that hulled hemp seed, hemp seed protein powder, and hemp seed oil can be used in food, in part because they contain only trace amounts of CBD and THC. But full spectrum hemp oil contains a host of the beneficial compounds found in the hemp plant, including CBD. We don’t know how the FDA will treat these types of products; the agency is in fact in the process of determining its approach toward hemp and hemp-derived products. What we do know is that the FDA is, for now, focusing enforcement actions against CBD products making illegal health claims. But this doesn’t mean full-spectrum hemp oil is permanently safe.

Given the FDA’s history and their desire to protect the drug approval process, it wouldn’t surprise us if the agency leans toward a ban. But there is some reason for hope. In addition to the bill that has been introduced, the FY 2020 Senate Appropriations Committee encouraged FDA to allow CBD in dietary supplements and food, though with some restrictions. Notably, the appropriations report states, “The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health.”

The FDA is already providing cover for a ban on all CBD products. Note that the report language asks for a pathway for CBD to be allowed in supplements “if such pathways are consistent with protection of public health.” In late November of this year, the FDA posted information to its website warning consumers of the harms that CBD can cause, including liver damage and male reproductive toxicity.

The irony should be clear. The FDA may claim that it is protecting public health (and not drug industry profits) by banning CBD products. Yet these products are safe, non-addictive alternatives to opioids, which are killing more Americans every year than traffic accidents. The FDA has this completely backwards.

We must support this bill to protect CBD and hemp oil.

Action Alert! Write to Congress and tell your representatives to support legislation to legalize CBD supplements. Send your message immediately.

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