#067: NPA vs. Dick Durbin's 2022 Supplement Bill (S.4090)
https://blog.priceplow.com/podcast/npa-vs-dick-durbin-s4090-067: A bill (S.4090) introduced by Senator Dick Durbin would require PRE-APPROVAL from the FDA for all dietary supplements. Led by Dan Fabricant, Joe Weiss, and Doug Kalman, The Natural Products Association (NPA) is fighting back.
On April 26, Senators Dick Durbin (IL) and Mike Braun (IN) proposed a bill titled Dietary Supplement Listing Act of 2022,[1,2] which would have serious ramifications on the way business and commerce is done in the dietary supplement industry.
We invited a powerhouse team of industry veterans and experts to discuss what this bill would mean for the industry:
Daniel Fabricant, Ph.D - CEO/President of the Natural Products Association (NPA)
Joe Weiss - President of branded ingredient developer Nutrition21 and NPA Board Member
Doug Kalman, Ph.D - Senior Vice President of Scientific and Regulatory Affairs for The Natural Products Association
All Dietary Supplements would now need FDA pre-approval?
The discussion centers around the text of the bill, and how its subtle wording would effectively create a situation where supplement manufacturers would require pre-market approval in order to enter the marketplace, otherwise they'd be deemed misbranded and subject to legal action.
Quick links before listening
Read the bill's text - https://www.congress.gov/bill/117th-congress/senate-bill/4090/text
Compose a message to your representatives - https://www.votervoice.net/NPA/Campaigns/94238/Respond
Video: PricePlow Invites the NPA to Discuss Dick Durbin's S.4090
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Detailed Show Notes
The Natural Products Association is the leading trade association for dietary supplements, known for its strong lobbying presence in Washington D.C. It acts as an industry watchdog on regulatory and legislative issues.
0:00 - Introduction to the situation
0:40 - Guest introductions
3:30 - Dan Fabricant's opening statement:
This is a listing bill, and in many ways, the agency already has the information this bill would mandate.
Signed in 1994, DSHEA is the prevailing law of the land for the dietary supplement industry. It was designed to give consumers access but with consumer protection, and it's done a great job of balancing those two. It's one of the safest commodities the FDA regulates, if not the safest.
This bill would restrict access and restrict the industry's size, while limiting consumer choices.
A listing authority "This is designed to give FDA a listing authority, where they're going to tell you basically what you can and cannot set your shelf with. That's a problem on a number of levels."
4:35 - Pre-Market Approval
What we're really concerned about is the pre-approval aspect of this bill.
"This is effectively pre-market approval for supplements... we don't have pre-market approval for orange juice or chocolate chip cookies or calcium in milk... so this is really odd".
5:00 - NDI (New Dietary Ingredient)
Dan explains how new dietary ingredients are brought to market through the NDI process.[4,5]
But with this bill, if you are using old dietary ingredients in the market, and merely change the flavor, you need permission from the government to go to market?! You have to make the list to go to market?! Seems very excessive.
6:15 - The bill's vagaries:
The crux of the issue: combining two critical parts of the bill
Dan reads a couple parts of the bill's text:
"...commercial distribution which has not been included in any listing previously submitted by the responsible person to the Secretary under this section shall be submitted to the Secretary prior to introducing the dietary supplement into interstate commerce."
Seems benign enough, just give them a listing. But wait,