This anti-health-freedom Congressional agenda has now gotten more threatening. The latest addition to the pro-more-FDA command-and-control over American common sense is H.R. 3156.  The official bill title is “The Dietary Supplement Access and Awareness Act.”  This name may be familiar. The bill, thus far only introduced in the House, is similar to now-defunct H.R. 3377 and S. 722 that were introduced in the last session of Congress.  However, H.R. 3156 has been revised and would be even more of a threat to health freedom and consumers of dietary supplements.

It was Representatives Susan Davis (D-CA), Henry Waxman (D-CA), and John Dingell (D-MI) who introduced this so-called “Dietary Supplement Access and Awareness Act.”  The bill would place all non-vitamin-and-mineral dietary supplements under unprecedented and unwarranted scrutiny.  It would subject all dietary supplements, excluding vitamins and minerals, to even stricter oversight than these products had prior to the passage of DSHEA in 1994.  DSHEA already gives the FDA the authority it needs to police the marketplace and keep bad products from being sold. This new version of the legislation goes well beyond the previous versions of the Durbin legislation.

As proposed, the legislation would regulate supplements in ways similar to prescription drugs.  It would require adverse event reports to be turned over to the FDA, even though other foods – including those with identical ingredients to supplements – do not have the same requirements.  It would require supplement companies to demonstrate that a dietary-supplement ingredient used in a supplement product is not adulterated - in other words, a requirement to disprove a negative.  Even small supplement companies would be required to register product labels with the FDA, notify the FDA when they no longer manufacture or process a supplement, and would grant broader FDA inspection powers.

Under the bill, only pure vitamin-and-mineral supplements would be exempted from the burdensome regulations.  Supplements like Vitamin C made with rose hips, for example, would be subject to the drug-like requirements of H.R. 3156.  The bill would allow the Department of Health and Human Services Secretary (effectively, the FDA) to declare that a supplement presents an “unreasonable risk” to the public, even if it cannot be proven by the FDA that a dietary-supplement substance has actually caused any real harm.  This provision was added to specifically address the recent Federal Court reversal of the FDA’s blanket ban on supplements containing ephedrine ingredients. 

The trade association for the majority of the dietary-supplement manufacturers in the US has estimated that if H.R. 3156 were to be enacted, seventy percent (70%) of supplements currently being used by Americans would be subject to the burdensome requirements being proposed – some of which requirements are equivalent to those required for prescription drugs.  Supplement manufacturers have a vested stake in preventing the passage of this legislation, but so do dietary-supplement consumers.  The bill would lead to higher costs for supplements, some of which already have hefty price tags.  There is also the possibility that many supplements, other than those that are only composed of pure vitamins and minerals, could be withdrawn from store shelves.  If the bill were to be enacted, it could very well become unprofitable, especially for small manufacturers, to comply with the drug-like requirements being proposed.  The continued access of the public, now and in the future, to a broad range of supplements is seriously threatened by this legislation.

The increased regulation of supplements stands in stark contrast to the actions of the pharmaceutical industry, which has and is looking to switch prescription drug ingredients and products into cheaper over-the-counter equivalents.  Doing this avoids some of the requirements being proposed in H.R. 3156.  While the FDA may not be directly complicit in this regard, it does suggest that there is a credibility gap that the FDA has, thus far, refused to respond to.  The safety record for dietary supplements far surpasses that of any drug products, whether prescription or over-the-counter drugs, and, for that matter, many conventional foods.  Under DSHEA, dietary supplements are regulated as a special class of foods.  So, why has the FDA not publicly rejected the need for Congressional bills like H.R. 3156, or its predecessors H.R. 3377 and S. 722? Alternatively, why has the FDA not supported similar regulatory requirements for foods and their ingredients?

There are many explanations to these two questions.  I will proffer the following for consideration.  Under current Food Drug &Cosmetic Act law, foods, including supplements, are not drugs.  Supplements have their own designation as a food category.  The FDA would never take on the food industry on such a matter as being able to withdraw a food product from store shelves even if it cannot be proven that an ingredient in a particular product has actually caused real harm.  People do get sick and do die each year, hundreds of thousands of them, from contaminated and tainted foods. 

The FDA never liked DSHEA.  It has not fully implemented the law ten years later.  (This is both good news and bad news since not all of the provisions in DSHEA are consumer beneficial.)  Since supplements are their own class of “foods,” they can be differentiated if the DSHEA law were changed.  The FDA has an economic incentive to have drug-like requirements for supplements.  As noted in previous reports, it is all about more money for the FDA.  For years, the agency has been charging drug companies “User Fees” to help cover the drug-approval and enforcement responsibilities of the agency.  There are “User Fees” for medical devices and veterinary products.  There are no such fees for foods, including supplements, now.

By changing DSHEA and having drug-like regulatory approval and post-marketing processes in place, the FDA could then establish “User Fees” for supplements.  The FDA has a Strategic Dietary Supplement Plan.  Every year, the agency requests more money from Congressional appropriators to carry out its “Plan.” Congress has not given the agency the additional funds it has requested.  Given recent Congressional history, the only avenue left for the FDA is to have Congress change DSHEA so that the agency can than go back and ask Congress for supplement “User Fees.”  The FDA has used this same legislative strategy before.  With “User Fees” established, the price for supplement products would have to be increased so that companies could pay the annual FDA User Fee.  So, higher costs and supplement prices to consumers would be inevitable so that companies could afford the added regulatory requirements and pay the FDA User Fee cost. 

The FDA has not and will not openly oppose legislation to repeal DSHEA because that is what they have always wanted.  And, if enacted, such legislation would be used as a means to justify “User Fees” to generate money, regardless of whether the FDA has done what it is already supposed to be doing under the current DSHEA law. With bills like H.R. 3156, supplement users lose twice and the FDA wins.

Seven out of 10 Americans use supplements as a safe, effective, and affordable way to maintain good health and enhance inadequate diets.  Some Congressional lawmakers and especially FDA bureaucrats and leadership, irrespective of the political party in control, have become dismissive of the rights of Americans to have access to complementary- and alternative-medical therapies and to improve their health and well being through the use of dietary supplements.

Rather than waiting to see what happens that may restrict personal choice, you can actively participate by contacting your own Congressmen/women in opposition to H.R. 3156.  More detailed information is available on the NHF website at:

www.thenhf.com/HR3156%20Ltr.pdf .