The Food and Drug Administration (FDA) has issued new rules that could potentially cause your favorite supplements to disappear from the market. These rules are targeting “new dietary ingredients” – natural health ingredients you’ve been relying on for years.
Before 1994, the FDA tried to make numerous supplements illegal. In response, the public fought back, leading to Congress passing the Dietary Supplement Health and Education Act (DSHEA). DSHEA protected supplements from the FDA – unless they could prove that the supplement wasn’t safe.
A Loophole in the Law
However, the 1994 law contained a loophole allowing the FDA to regulate new ingredients introduced after October 15, 1994. For the next 17 years, the FDA didn’t take any action, and the supplement industry thrived. The lack of regulation allowed innovation in the industry, leading to millions of people benefitting from improved and safer supplements.
But now, the FDA wants to change all that. They have drafted a proposal to regulate “new dietary ingredients,” which could force the removal of nutrients like resveratrol, ubiquinol CoQ10, bacopa, and strontium from the market.
Under the proposed guidelines, the FDA can define nearly anything as a “new dietary ingredient”. If a supplement includes a higher amount of an ingredient than it did 17 years ago, if an ingredient uses a different extraction process, or if the product contains an ingredient not found in nature, the FDA could label it as “new.” Appealing to the FDA to change its stance can be a long, expensive process, potentially leading to many of your favorite supplements being pulled from the market.
The Impact of These New Rules
Accommodating the FDA’s demands could cost supplement manufacturers hundreds of thousands of dollars per ingredient in testing, making it difficult for companies to stay afloat. The likely result would be many smaller supplement companies going out of business and increased costs for consumers.
Public outcry helped block the FDA’s previous attempts to put restrictions on vitamins and supplements in the 1970s and 1990s. You can help make a difference by reaching out to your elected representatives, such as your Congressperson and Senators, and sharing your concerns about the FDA’s proposed guidelines.
Talking Points for Contacting Your Officials:
- Supplements have an unrivaled safety record and are safer than drugs, medical devices, cosmetics, and even food.
- The FDA’s broad definition of “new dietary ingredients” will strangle innovation and deprive consumers of health-boosting supplements.
- The FDA had previously ignored new dietary ingredients for 17 years, allowing for tremendous innovation and consumer benefits. This change would eliminate those benefits.
- The FDA’s pre-approval scheme goes against the intent of the DSHEA law passed by Congress.
- These changes could be detrimental to public health by limiting access to preventive healthcare.
- The costs of compliance for supplement companies are astronomical, potentially leading to the loss of numerous jobs and costing the economy tens of billions of dollars.
What You Can Do
You can make a difference by reaching out to your elected representatives and sharing your concerns about the potential impact of the FDA’s guidelines. Contact your Congressperson, Senators, and even the President to voice your disapproval of the FDA’s actions. It is critical to act now to ensure that your favorite supplements remain available and affordable.
