The Dietary Supplement Labeling Act of 2011 (S.1310, often called “The Durbin Bill”) - This bill is named after the Senator who introduced it. The exact wording of the Durbin bill has now become available for public viewing.

As expected, the wording gives the FDA and the Institute of Medicine (IOM) the power to decide the safe levels and combinations of nutritional supplement ingredients. If the bill is passed, supplements would be controlled by an agency (the FDA) biased against nutritional supplements and an agency (the IOM) that ignored science to issue a pathetically low (600 IU) daily recommended vitamin D intake that will subject a large number of people to vitamin D deficiency.

If enacted, the Durbin bill would give the FDA broad new authority to ban supplements or supplement ingredients on totally arbitrary grounds, with no rules or standards, making it more likely decisions will be based on bias rather than science. This would drastically reduce the number of supplements and supplement potencies, raise prices substantially, impact our ability to enhance our own health, stifle supplement innovation, and cost millions of jobs in the supplement industry.

S.1310 has been referred to the Senate Health, Education, Labor, and Pensions Committee for further deliberation. Please contact your senators and ask them to oppose it. And please tell your Congress people that the FDA’s NDI guidance is bad for consumers and is infringing upon your health freedom rights.

Testimonial Free Speech Act (HR 2908) - Congressman Ron Paul, a strong health freedom advocate, has introduced an important bill called the Testimonial Free Speech Act, HR 2908. The bill protects your First Amendment rights to share how a nutritional supplement has improved your health. Currently, nutritional supplement companies are prohibited from using testimonials from customers who praise their products. The new bill would allow nutritional supplement companies to disseminate testimonials “containing a consumer’s actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer’s experience with that food or dietary supplement.”

The bill takes on the FDA’s contention that only drugs can cure, mitigate, or treat disease. When a nutritional supplement company mentions the therapeutic benefits of supplements—whether through personal testimonials or citied scientific literature—the FTC automatically considers this “misbranding.” HR 2908 has been referred to the House subcommittee on health.

A perpetual defender of supplement consumers’ rights, Ron Paul introduced two other bills into the current Congress. The Health Freedom Act, HR 2044, introduced back in May and referred to the Subcommittee on Health, prohibits FDA from preventing a disease claim unless it is “false and misleading in a material respect” as shown by final order of a Federal court of competent jurisdiction following a trial. In order for it to be “false and misleading in a material respect,” the court must find clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research. The act also amends the Food, Drug, and Cosmetic Act to say, “A food or dietary supplement for which a claim is made…is not a drug solely because of such claim.” This bill has been referred to the House subcommittee on health.

Another Ron-Paul-sponsored bill, The Freedom of Health Speech Act, HR 2045, increases the burden of proof required by the FTC to prove false advertising cases against dietary supplement manufacturers and specifies that excerpted scientific studies will not be considered advertising. HR 2045 has been referred to the Subcommittee on Commerce, Manufacturing, and Trade.

We urge you to contact your Congressional representatives today and ask them to support all of Ron Paul’s health-freedom-related bills.

The FDA’s Draft Guidance on New Dietary Ingredient Notifications - This also threatens consumers’ health freedom. It’s FDA’s newest way to try to give drug companies the right to patent your favorite supplements and make them available by doctor’s prescription—only for 10 or 100 (or even more) times what you’re paying now. The biggest problem is that this will create such huge barriers for supplement manufacturers that it will be more difficult and expensive to produce the supplements.

The FDA’s comment period for responding to the Draft Guidance on New Dietary Ingredient Notifications ended on December 2, 2011. VRP submitted comments through our FDA attorneys. Additionally, acclaimed attorney Jonathan Emord, on behalf of the Alliance for Natural Health—USA (ANH-USA), submitted comments that showed that the FDA is engaged in substantive new rulemaking, in violation of the federal Administrative Procedure Act (APA).

Previously, the ANH-USA also filed an analysis that breaks down all the flaws in this guidance. Here are some of the ANH findings:

• The FDA says all new supplements since 1994 must be approved, but claims this will result in only 55 new applications. However, experts predict as many as 125,000 new applications, and the sale of these supplements will be illegal while the FDA decides what to do with them.
• The FDA’s new guidance can be expected to force significant numbers of products off the market, causing a loss of more than $1 billion in revenue and 100,000 jobs.
• The FDA says only 20 employee hours are needed to do an NDI submission. However, the ANH analysis shows it will take between 100 and 350 hours of employee time and between $845 million and $6.1 billion in employee wages.
• The total cost to industry for animal and human product safety studies will be between $2 billion and $165 billion. The only way the supplement industry could raise this money is through price increases. The FDA’s strategy? Fail to approve many supplements, then make the rest too expensive for the average consumer.
• The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.

At a time when we need to find ways to save money on healthcare, it’s inexcusable that the FDA wants to make proactive natural health solutions more expensive for the consumer and put nutritional supplement companies out of business. We will keep you updated on how this situation unfolds.