FDA Expands Supplement Attack, Targets Hemp Oil

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.

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Please protect hemp oil and other supplements

Dear [Decision Maker],

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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.

Full spectrum hemp oil is an extract of the hemp plant that contains CBD and a host of other beneficial compounds. 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.

The FDA's actions against CBD, a beneficial compound found in the hemp plant, are an effort to protect drug industry monopolies. 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.

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.

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.

Congress must step in and ensure that Americans can continue to access safe supplements like hemp, CBD, and a host of other products.

Please support HR 841 and S 1698 to protect hemp oil and CBD. Please direct the FDA to fix the NDI guidance so unfair safety standards are not applied to supplements that will negatively impact consumer access.

Sincerely,
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