FDA submits CBD enforcement policy draft guidance to White House

(This story has been updated to include industry reaction.)

Federal food and drug officials submitted a CBD enforcement policy document for approval on Wednesday, Hemp Industry Daily has learned, meaning that long-awaited industry guidance on CBD is nearing.

The U.S. Food and Drug Administration submitted its Cannabidiol Enforcement Policy Draft Guidance for Industry to the White House Office of Management and Budget.

With approval from the OMB, which must sign off on new regulations from any federal agency, the public release of the enforcement policy could come in only a matter of weeks.

The action might mean clarity could finally be coming to the CBD space, said cannabis attorney Jonathan Havens, a Washington DC-based partner with Saul Ewing Arnstein & Lehr.

Havens wrote in a LinkedIn post Thursday that the enforcement policy could be claims-focused – meant to control the illegal, unsubstantiated claims that companies have been making regarding their CBD products.

“It’s hard to believe that the agency will back off completely from its ‘ingestibles aren’t permitted’ stance,” he noted.

Havens wrote in an email to Hemp Industry Daily that it’s not clear which direction the FDA is going and hard to say what is going to happen, based on the enforcement policy.

“It could be claims-based, serving size-based, (which is) less likely, product standards-based, some combination of the three, or something else,” Havens wrote.

“On the standards front, it’s possible FDA could start to hold ingestible CBD marketers to the agency’s dietary-supplement regulations, for example good manufacturing practice requirements.”

Such standard are what the supplement-industry trade associations have been pushing for, Havens said.

“It would raise the bar for the industry, push out unsavory firms who are producing unsafe products and allow marketers to say that they comply with FDA requirements, which would hopefully smooth out the true patchwork of state requirements, among other benefits.”

The move comes on the heels of the FDA on Tuesday releasing draft guidance for clinical research related to developing cannabis and cannabis-derived drug products.

Havens told Hemp Industry Daily that the new guidance for research and development for cannabis-based drug products could provide a glimpse of what the process could look like when the agency drafts guidance for ingestible products such as dietary supplements.

“In the normal course of how the FDA generally goes about things in the food and beverage docket,” Havens said, “you’re going to have multiple steps: an advanced notice of proposal rule-making, a proposed rule, comments, FDA considers the comments, the final rule and implementation.”

Laura Drotleff can be reached at [email protected]

15 comments on “FDA submits CBD enforcement policy draft guidance to White House
  1. Alan Parker Reid on

    Just end the prohibition of cannabis. The FDA should be shut down boarded up and their officials locked up. The FDA is the arm of big pharmaceutical industry has never been anything more than a lapdog to big Pharma. APR4U

    Reply
  2. Derek Cloar on

    ALL CBD products are potentially unsafe for some individuals. Are we total idiots? So deeply in love with weed and money that we care not about truth? What we are doing is driving down the wrong path and not one person wants to wake up and comprehend.
    Shame on every last one of you.

    Reply
    • Matt Terrill on

      Most CBD products are safe! Less than 1% of people could theoretically be harmed while In reality 99% can be helped with CBD. We can have a rational discussion about how to mitigate the risk for that 1%. Getting hysterical about it doesn’t help- that’s as silly as people advocating a total ban on peanut products because <1% of people have peanut allergies.

      Reply
    • matt terrill on

      Most CBD products are safe! Less than 1% of people could theoretically be harmed while In reality 99% can be helped with CBD. We can have a rational discussion about how to mitigate the risk for that 1%. Getting hysterical about it doesn’t help

      Reply
    • Chris Molitor - Scranton, Pa. on

      Potentially unsafe??? Marijuana nor CBD have ever been linked to a single death. How many people die every year from the poison the pharmaceuticals and doctors are pushing? FOH!

      Reply
    • Cliff Friedland on

      I believe having a process such as cGMP, product labeling and in vitro and mammalian studies will help establish the benefits as well as any potential side effects. By establishing rules for policing the process manufacturing, labeling and other large hurdles to overcome, this ruling will knock out the bad actors in the industry. Without any rules, you leave the public in a much larger risk by allowing bad companies to continue to sell products that do not have homogenous dosing and shelf life testing. Companies that have the public interest at heart and whose reputation is their whole business, will be motivated to spend the lab research and studies necessary to establish both efficacy and safety and correct labeling.

      Reply
    • Bill Murphy on

      Peanuts, mayonnaise, milk and many other things are also unsafe for some people. You must be a Big Pharma TROLL

      Reply
  3. John Gualt on

    So basically the FDA is still not doing anything and dragging out the process to slowly kill the CBD industry. They are worthless! It is clear they are in bed with big Pharma and will never be on the side of farmers or small biz. Typical gubmint.

    Reply
    • Kevin on

      No, that’s not at all what this is, it’s just saying that within a few weeks we will know what the guidelines are and what direction the fda took

      Reply
  4. Dr. Jon Thompson on

    “Meant to control the illegal, unsubstantiated claims that companies have been making regarding their CBD products.” Definitely all for this. But we need the doors open for it to be easier to conduct studies to verify claims. At extraktLAB we have been conducting unofficial studies. We are looking to connect with some Wisconsin local specialist who can help conduct these with us.

    Reply
  5. Custodial Artist on

    Keep the feds out of it. What good has government regulation ever done that cant be done by the consumers. Sure some vapes got tainted. Would the FDA have caught it first? Like they did with salmonella infested meat or vegetables over the years? Nope. People must stop relying on regulations to feel safe. Its just another way to take our money and choose winners in a very tough industry.

    Reply
  6. Charles Walters on

    All I know is, my 13-1/2-year-old basset hound would not be alive today without the pain relieving benefit of CBD oil. If some bureaucrats in Washington, D.C. arbitrarily decide to outlaw it, they are sentencing my beloved dog to death.

    Reply

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