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Consumer and health freedom advocacy groups hail the defeat of the Durbin Amendment as a victory for dietary supplement users.

While failing to effectively improve dietary supplement safety, the Durbin Amendment would have threatened consumer access to dietary supplements. It would have significantly increased the paperwork burden on manufacturers, requiring them to file numerous documents with FDA for each product sold or modified. On May 24, 2012, the US Senate rejected the Durbin Amendment by a vote of 77 to 20.

Senator Orrin Hatch and Senator Tom Harkin argued convincingly against the Durbin amendment, as reported by the National Product Insider:

With his time at the podium, Hatch argued it would be a case of overregulation. He said instead of urging FDA to use its existing authority—all recent agency commissioners have said DSHEA (the Dietary Supplement Health and Education Act of 1994) provides ample authority to FDA—Durbin’s amendment serves to punish all responsible companies with its overreaching mandates. He added the amendment would pile more work on an underfunded agency struggling to keep its head above water with it core responsibilities. “It took over 10 years to get GMPs (good manufacturing practices) completed by FDA,” he said. “Now adding other regulations to this industry is just plain not right.” He urged fellow Senators to vote against this amendment.

Harkin also had the floor for a few minutes and noted under DSHEA manufacturers already are required to list all their ingredients on the label; when a product is reformulated, the label must be changed to reflect this. “We added this to DSHEA for consumer protection,” he said, noting Durbin is a consumer protection champion. He further added dietary supplement companies already have to register biennially (every two years), under the recently passed Food Safety Modernization Act (FSMA). Also, there is a voluntary program for supplement companies to submit their labeling to the NIH’s Office of Dietary Supplements (ODS).

Durbin brought up the topics of unsubstantiated and illegal disease claims made for supplements, as well as adulteration. There are already regulations in place for claims and adulteration (see GMPs, noted by Hatch in his arguments). Registration of basic information has nothing to do with adulteration and claims. Hatch actually rebutted the assertions with a reminder FDA has to approve health claims for supplements, and most supplements are limited to use of structure-function claims, which also are overseen by FDA.

With the final debate minutes, Durbin reiterated his earlier criticism that dietary supplements aren’t tested. In fact, GMPs are filled with testing requirements.

In the May 23, 2012 US Senate Session, Senator Durbin centered his arguments in favor of the Amendment on the need to better regulate energy drinks.

Currently, energy drinks manufacturers enjoy ample flexibility in deciding whether to market their product as a food or as a dietary supplement. See this excellent explanation.

To support his amendment, Sen. Durbin argued that:

  • Most energy drinks avoid FDA oversight by marketing their products as dietary supplements.
  • His amendment was meant to curb the prevalence of drinks and foods.  masquerading as dietary supplements as a means of avoiding regulation by the FDA.
  • His amendment would have required FDA to establish a clear definition of which products are foods and should be regulated as such and which products are meant to be regulated as dietary supplements.

Unfortunately for Senator Durbin, his amendment would have failed to effectively address the energy drinks problem, when you consider the following logic sequence:

  1. Sen. Durbin wants mandatory registration of dietary supplements
  2. Sen. Durbin wants energy drinks to be better regulated
  3. No clear definition exists of whether energy drinks should be regulated as foods or as dietary supplements.  Foods are more strictly regulated than dietary supplements. Many energy drink manufacturers choose to market energy drinks as dietary supplements to avoid stricter food regulation.
  4. Sen. Durbin wants FDA to clarify whether energy drinks should be regulated as foods or dietary supplements.
  5. Sen. Durbin seems to favor regulation of energy drinks as foods. In that case, energy drinks would escape the mandatory dietary supplements registration requirement.
  6. This would render mandatory dietary supplements registration useless in the fight to regulate energy drinks.

Absent evidence to the contrary, we must conclude that Senator Durbin’s amendment would have fallen short of his declared goal of better regulating energy drinks.

Overall, the Durbin Amendment would have been ineffective and problematic and, while failing to increase safety, may have rendered dietary supplements less accessible to the public. Senators Hatch and Harkin, once again, protected the freedom of dietary supplement users.

I would love your opinion on this. Please comment below. I will publish all well-written responses and/or questions, even if they disagree with my opinion.

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