UPDATE May 25, 2012: Yesterday’s vote regarding Senator Durbin’s proposed amendment to the pending FDA Safety and Innovation Act was tabled. A Senate vote of 77 to 20 has removed Durbin’s amendment from consideration in the overall bill.
Durbin sponsored an amendment that would change the current FDA regulation of natural supplements and potentially cause many products to be removed from shelves. His amendment was introduced on Tuesday, May 22 and the voting took place two days later. In two days’ time supplement industries, consumer rights organizations, along with the Natural Products Association (NPA), American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and Citizens for Health sent word to their supporters urging them to contact their Senators to oppose Durbin’s plan. As a result, the amendment was not passed and no change will occur to the current law regarding natural supplements. According to the Natural Products Insider, AHPA President Michael McGuffin is very pleased.
“I have worked with my colleagues from each of the other supplement trade associations over the last several days in this call for prompt and cooperative action, and I am pleased that this effort reaffirms the incredible unity of the dietary supplement industry when legislative threats to DSHEA emerge.”
Illinois Senator Richard Durbin has proposed an amendment that would require supplement manufacturers to register with the FDA. Due to the terms of this amendment, if passed, many supplements will be ripped from shelves within the next 30 days.
The vote is scheduled to take place this afternoon, Thursday, May 24. If Durbin’s plan is accepted, a mandate will be placed on supplements requiring information to be provided to the FDA. That information includes a description of the supplement, a list of ingredients, a label for all supplements, and updated information for each new, reformulated, or discontinued product. All of these requirements will fall under the Senate FDA Re-authorization for User Fees bill.
If this amendment passes, supplement companies that fail to register with the FDA within 30 days will be considered “mis-branded” and may be subject to severe financial fees and possibly even jail time.
Currently, supplements operate under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act states that the manufacturer is responsible for ensuring the safety of a supplement before it is marketed. The FDA is only involved if a product is found to be unsafe after it’s on the market.
While the amendment will affect pills and natural food supplements, Durbin seems to be most concerned about the content of energy drinks. He has even referenced a case of a young woman who died as a result of using an energy drink. The senator wants the FDA to evaluate the difference between a drink and a liquid dietary supplement, and feels energy drinks are dodging regulations by claiming to be a dietary supplement. If they were categorized as drinks they would have to be regulated like all other food and drink products.
Natural supplement suppliers and users have had a short window to petition their local senators and encourage them to vote against the amendment. Due to this, tomorrow may bring major change to the natural supplement industry as we know it.
May 24th, 2012