An Exchange on Regulation of Supplements

By Bruce Silverglade, Center for Science in the Public Interest

I would like to clear up some confusion regarding CSPI's position on dietary supplements. CSPI supports the right of consumers to purchase safe, high quality, and appropriately labeled dietary supplements without a prescription. As we all know, more and more scientific studies point to the potential benefits of many supplements and consumers should certainly have the right to purchase such products without government interference.

CSPI also believes that supplement labels should be able to include health claims that are supported by sufficient scientific evidence. CSPI worked hard to ensure the passage of the Nutrition Labeling and Education Act of 1990 (NLEA). This law sets criteria that the Food and Drug Administration (FDA) must follow when allowing health claims for foods and nutritional supplements.

Some organizations have charged erroneously that the NLEA allows the FDA to ban the sale of many types of supplement products. Others have claimed that FDA regulations implementing the NLEA will require consumers to obtain a prescription before purchasing a dietary supplement. Neither charge is true.

The supplement industry is urging consumers to contact their elected representatives in Washington, D.C. in support of legislation sponsored by Representative Richardson and Senator Hatch that would repeal portions of the NLEA. We urge the public to fully consider the effect of such legislation before writing their congressman or senator.

The NLEA is a landmark consumer protection law. Prior to the enactment of the NLEA, all health claims on food and dietary supplement labels were considered by the FDA to be illegal, unapproved claims for so-called new drugs. In light of all the new knowledge about the benefits of a proper diet and supplements, CSPI felt that well supported health claims should be allowed on labels. As a result of the passage of the NLEA, dietary supplement producers will, for the first time ever, be legally allowed to make health claims on certain products.

Under the NLEA, the FDA this past January allowed health claims for low fat, low cholesterol and low sodium foods, as well as for foods high in calcium, vitamins A and C, or fiber. The FDA also allowed claims stating that calcium supplements can reduce the risk of osteoporosis. We believe the agency should consider allowing additional health claims for supplements.

The NLEA sets up a procedure that allows consumers, supplement manufacturers, and others to petition the FDA to allow additional health claims. One need only show that the claim is supported by significant scientific agreement -- one does not have to provide the type of expensive clinical data necessary to gain FDA approval of a new prescription drug. This procedure ensures that health claims are reliable, protects consumers from fraudulent health claims, and increases the credibility of claims that are made. You can be assured that we will be working to see that the FDA faithfully implements this requirement.

If Congress repeals this provision in the NLEA, it will be nearly impossible to prevent unscrupulous individuals (be they big or little companies, private nutritionists or physicians) from defrauding the public by marketing supplements deceptively. For some consumers, it might become increasingly difficult to distinguish between products that make well supported health claims and others that promise a world of health benefits but deliver only broken promises.

Instead of repealing the NLEA, we favor new legislation that would ensure that the FDA regulates supplements appropriately. CSPI's Dietary Supplement Consumer Protection Act would provide funds for further research on the potential benefits of supplements and set up an advisory committee to guide the FDA with supplement regulation. Our bill would also ensure that supplements are manufactured safely in accordance with appropriate quality standards, and require supplement labels to disclose the level at which products may cause adverse reactions in children or particularly sensitive individuals. The passage of such legislation is important given that more and more consumers are relying on supplements to protect and promote their health.

We hope this letter clarifies our position on dietary supplements. We also hope that we can count on you to urge your elected representatives to support legislation that will truly benefit supplement consumers.

In response: "Inaccuracies and Basic Misunderstanding"

An open letter to CSPI from cooperative leaders:

We have been members and supporters of Center for Science in the Public Interest for years, and have participated in and supported many of your campaigns. Thus, we are surprised and dismayed at the position you have taken on the dietary supplement legislation currently being proposed in Congress.

We manage or work with consumer owned retailers and wholesale distributors of natural foods, including supplements and herbal products. Our members include tens of thousands of consumers as well as hundreds of health foods stores and grocery stores that sell natural foods. We have been actively involved in the debate over regulation of supplements for several years.

We too believe that NLEA is landmark consumer legislation. We too believe that it is important for manufacturers to be required to substantiate their claims, accurately label their products, and ensure the purity and safety of their manufacturing processes. However, we actively support the S784/HR1709 bills currently in Congress.

Your letter to co-ops contains some inaccuracies, and a basic misunderstanding of our support for the S784 bill. You seem to be guilty of the same type of overstatement designed to scare consumers that you accuse the health food industry of using. You imply that the passage of S784 will flood the market with dangerous and unreliable products, which is not the case. And you imply that the consumers who are writing in support of S784 by the thousands are doing so because they are being duped by vitamin manufacturers. In fact many of us are intelligent people who read labels, own small businesses and subscribe to magazines such as yours, Nutrition Action. Our support of the legislation is based on information, experience, and observation of the approach the FDA has taken in general toward health food products and self-help medicine in the past.

There should be an opportunity here for consumer advocates and the natural foods industry to work together toward the responsible regulation we all want, and at the same time preserve access to products that are important in self-help and preventive care. Instead we are in danger of letting the FDA define the rules, and of losing a strong consumer voice in the process because we are not working together.

Nutritional and herbal supplements are an increasingly important element of preventive health care, and an essential part of any strategy to reduce health care costs in the U.S. For years they have been one of the few areas within which consumers could take an active role in their own health. As you know, most traditionally-trained physicians in this country have a minimal knowledge of nutrition, and almost non-existent knowledge of traditional herbal remedies. There is a well established and reliable body of both scientific and folkloric knowledge about the use of these products, knowledge which has given many people access to self-help means of preventive care.

When you appear on national TV and refer to natural foods stores as "snakeoil salesmen,' you do a disservice to businesses such as ours that place a high value on consumer information and service. No one would disagree that there is a need to ensure that consumers have accurate, reliable and complete information about products offered on the market. The FDA says this is their goal, and it is certainly the goal of the natural products industry. Along with exposing the small number of unscrupulous or careless vendors in our industry, we would like you to join us in supporting the majority who have worked hard to provide responsible alternatives.

What is at issue is the FDA insistence on defining these products in terms of either very broad "food" guidelines or very narrow "drug" guidelines. Neither makes sense for a category of products that are used preventively and therapeutically, but which are essentially made up of common food and plant ingredients that cannot be patented and marketed as drugs. A separate category of regulations is needed, and the goal of S784 would be to provide that. We challenge several statements made in your letter:

1. S784 would not allow misleading and unsubstantiated claims about supplements, as you state. In fact, it would specify much more clearly how those claims are to be regulated for supplements including herbs, rather than dealing with them sometimes as food additives and sometimes as drugs, as is done in the NLEA version.

2. S784 would not repeal key portions of NLEA. Again, it would remove supplements and herbal products from parts of the current provisions and create a separate set of regulations specifically for these products. Under those regulations, the same high standards of safety, purity and labelling accuracy should be required as under NLEA.

3. You state that NLEA does allow claims to be made for supplements. However, currently the only allowable claims are extremely limited, unreasonably so. In fact, the FDA has rejected 6 out of 7 claims specifically suggested by Congress when the NLEA was approved. These claims include Omega 3 fatty acids preventing heart disease, zinc promoting immune function in the elderly, folic acid preventing neura tube defects, the role of fiber in preventing cancer and cardiovascular disease, and the role of antioxidants in preventing cancer. These are all claims with significant support, including support from the government's own research agencies. This seems to indicate that the way the FDA interprets "significant scientific agreement" is far too narrow, and that wording such as that proposed in S784 -- "accurately represents the state of scientific evidence as of the date of the evaluation of the claim" --will set a more reasonable standard.

4. You claim that concern that the FDA will ban herbs and other supplements or require prescriptions for them is just a scare tactic. In fact, it is founded in observation of FDA actions over the past several years, and specific statements made by FDA officials. As recently as March 1993, FDA deputy commissioner Michael Taylor said, in reference to the use of herbs, "It is a simple fact that these products are legally drugs and properly regulated as drugs."

5. You claim that without the current version of NLEA rules, it will be "nearly impossible" for the FDA to prevent misleading products from reaching the market. Yet the FDA currently has broad powers to act when public health or safety is endangered by any product, and those powers would be specifically strengthened by S784 in relation to supplements.

Nearly all of the provisions you cite in the last paragraph of your letter as part of the CSPI sponsored bill are also specifically called for in S784. Why not see if CSPI and the natural products industry can join forces to ensure that we have the best possible regulations, protecting both public safety and public access?

We invite CSPI to sit down with representatives of the consumers and businesses that make up the natural foods industry, and attempt to reach agreement on legislation that will be truly consumer-oriented, not governed by the interests of either manufacturers, of the FDA, or the powerful drug and medical interests that have tended to dominate health care policy in the past. As members of the National Cooperative Business Association, the trade association representing cooperatives, we would be glad to offer our Washington office as a forum for discussing these issues.

As members and longtime supporters of CSPI, we believe you owe us a more thoughtful and respectful hearing than you have so far given. We welcome the opportunity to discuss this issue further. We believe it has important implications for all of us in defining the role we want government to have in making choices for us or in helping us to make informed choices for ourselves. Even more profoundly, we think it has implications for the future of our medical system, which nearly everyone agrees is bankrupt in its stewardship of the public health. As stated above, given the past support we have had for CSPI, we are surprised and disappointed at your position on S784. We look forward to hearing further from you.

Theresa Carbrey, New Pioneer Cooperative
Goldie Caughlan, Puget Consumers Co-op
Sue Futrell, Blooming Prairie
Dave Gutknecht, Cooperative Grocer
Paul Hazen, National Cooperative Business Association
Kathy Larson, Frontier Cooperative Herbs