Schumer bill mandates legal pathway for CBD supplements, directs FDA to set safe upper exposure limit

Schumer’s bill, called the Cannabis Administration and Opportunity Act, is cosponsored by Senators Cory Booker, D-NJ and Ron Wyden, D-OR.  The bill proposes a framework to legalize the cannabis trade as a way to unwind that portion of the decades long federal War on Drugs which, the bill notes, has disproportionately affected communities of color.

Miscarriage of justice

The draft bill states: “According to the American Civil Liberties Union (ACLU), enforcing cannabis prohibition laws costs taxpayers approximately $3,600,000,000 a year.​

“The continued enforcement of cannabis prohibition laws results in over 600,000 arrests annually, disproportionately impacting people of color who are almost 4 times more likely to be arrested for cannabis possession than their White counterparts, despite equal rates of use across populations.”​

Legal trade in CBD, daily exposure considerations

While the majority of the large bill, whose discussion draft extends to 161 pages​​, pertains to the trade in cannabis products, a portion is directed at CBD.  The bill specifically carves out a legal trade in these items.

According to a 29-page summary of the bill​​, “This section would amend the definition of dietary supplement to remove the prohibition on marketing CBD as a dietary supplement.” ​

In addition, the bill mandates that an upper safe level of daily CBD exposure be established, and also states that, “Certain dietary supplements would be required to submit New Dietary Ingredient (NDI) notifications to FDA. Additionally, the section would clarify that FDA would have the ability to require safety-related labeling or packaging requirements if needed and give FDA the ability to take enforcement action against any noncompliant CBD-containing products that is inappropriately labeled as a dietary supplement.”​

Trade groups welcome CBD language

Jonathan Miller, an attorney with the firm Frost Brown Todd and the chief legal officer of the US Hemp Roundtable, said his organization hasn’t had time to parse through the whole bill, so he demurred on giving a reaction to the news from the standpoint of his group’s full membership.

“But from me individually, I can say that we are very pleased that this would provide a pathway for the sale of CBD as a dietary supplement,”​ he told NutraIngredients-USA.

During the discussions with FDA around how to find a legal pathway to market for CBD products, The Natural Products Association has consistently advocated that the Agency must set a maximum safe daily exposure limit as a starting point in that process.

“It wasn’t like were we were asking for that just to be different,” ​said Daniel Fabricant, PhD, president and CEO of NPA.  “That’s how FDA has always done it.  Now we are in the same position on that as the Senate Majority Leader, which is not a bad place to be.”​

Bill likely to change significantly

Fabricant noted that the draft bill surely will go through many changes before it might become something the full Senate might vote on.

“I think what’s going to happen is they will break this up into as many pieces as appropriate, such as the criminal justice aspects.  At least the CBD thing is out there in terms of legislative language, and this could serve to put FDA on the clock,”​ he said.

“We will be having many discussions with Senators’ offices going forward.  Not having the food piece in there is odd, for example,”​ Fabricant added.

Miller added his own caveat on the bill’s initial language.

“We are supportive of the FDA ultimately setting limits on serving sizes, but we be believe that should be done through a full rule and comment process,”​ he said.

Loren Israelsen, president of the United Natural Products Alliance, said while some of the bill’s language might be welcome, it’s unclear how much of a chance it stands of passage in its current form, and therefore how influential it will prove to be.

“I think there will not be 10 Republican Senators to support this bill.  With that said, it’s unclear how this might advance the hemp/CBD pathway to lawful status.  This is a very big step, and while it is following the social and cultural trends in the county, the question is whether for some more conservative people this will just be moving too fast,” ​he said.