CRN Testifies at NYC Council Hearing on Dietary Supplements

Mr. Cordaro's testimony urged the NYC Council to reject both proposals, based on the following:

• Dietary supplements are extensively regulated both by state and federal laws and regulations, and when used as directed, are safe and beneficial.
• Ephedra dietary supplements are appropriately marketed to consumers, in a manner consistent with federal, state and local laws. Additionally, industry self-regulation activities include voluntary label information that alerts consumers to appropriate use, age limitations and potential adverse reactions.
• The NYC Council resolution and bill do not provide any new consumer protection, and most likely will discourage people from using supplements that potentially enhance health and well-being.

"More than 100 million Americans, several million of whom live in the New York City area, use dietary supplements to enhance their health and reduce the risk of certain diseases. CRN urges the NYC Council to take a balanced and scientific approach to dealing with these products, in a way that will protect the public and not cause unintended harm," Mr. Cordaro said.

Required posting of signs advising consumers to seek medical advice when taking dietary supplements is highly inappropriate and counterproductive, Mr. Cordaro told the NYC Council. He posed this question to the group: "Can you imagine making an appointment with your physician to ask 'Is it okay for me to take these multivitamins?'"

The Council for Responsible Nutrition (CRN) was founded in 1973 and represents approximately 100 companies in the dietary supplement industry, including bulk ingredient suppliers as well as finished product manufacturers. Members include manufacturers of national brands of dietary supplements as well as several large manufacturers of the store brands available in most supermarkets, drug stores, health food stores, and super stores. CRN members adhere to a strong Code of Ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.

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Statement of
John Cordaro
President and Chief Executive Officer
Council for Responsible Nutrition

Before The Committee on Consumer Affairs
The Council of the City of New York

February 10, 2000

Madam Chair, Councilwoman Koslowitz, the Council for Responsible Nutrition (CRN) appreciates the opportunity to testify before the Committee on Consumer Affairs as it reviews Resolution 912 and Introductory Bill Number 583.

The Council for Responsible Nutrition (CRN) is a trade association that represents approximately 100 companies in the dietary supplement industry. More than 15 CRN members are located in the New York area.

In my presentation today, I will make the following points:

1. Dietary supplement products are extensively regulated by both state and federal laws and regulations, and when used as directed, are safe and beneficial.
2. Ephedra dietary supplements are appropriately marketed to consumers, consistent with federal, state, and local laws, plus voluntary industry self-regulating label information on appropriate use, age limitations, adverse events concerns, and other useful information.
3. The New York City Council resolution and bill do not provide any new consumer protection and, most likely, will scare people away from using supplements that significantly enhance their health and well-being.

Underlying these points are the responsible character of CRN member companies and the vast majority of all other dietary supplement companies, who are firmly committed to providing consumers with useful science-based information and safe products made to quality standards.

An internationally recognized scientific staff that includes four Ph.D.s demonstrates CRNœs commitment to a science-based industry. These staff members are former employees of the U.S. Food and Drug Administration and the National Cancer Institute and a prominent member of the Presidential Commission on Dietary Supplement Labeling. CRNœs core scientific staff has been at the heart of rigorous self-regulation, based on a code of ethics, GMPs, and appropriate informative labeling.

Specific to todayœs issue, CRN has responded to the U.S. General Accounting Office (GAO) analysis of FDAœs rulemaking on ephedra. GAO concluded that additional scientific analysis was needed. CRN has contracted with Cantox Health Sciences International to perform a risk assessment on ephedra products used as dietary supplements. CRN has undertaken this voluntary initiative to develop a comprehensive evaluation of the safety of ephedra by a neutral, credible risk assessment group. Cantoxœs world-renowned scientists will perform a thorough investigation of all non-clinical and clinical safety databases and all published scientific work to derive a safe upper level of intake, based on available scientific data.

Consumers Need and Use Dietary Supplements

An extensive body of credible scientific research has established that increasing intakes of specific nutrients may be helpful in protecting against debilitating and deadly diseases and conditions that range from birth defects, macular degeneration and cataracts to osteoporosis, heart disease and cancer, among other diseases. As a result of the value that dietary supplements have in promoting health and helping to reduce the risk of certain diseases, more than 100 million Americans use supplement products. Frequent, responsible use of dietary supplements has been shown to help reduce the cost of health care in the U.S. by billions of dollars.

Resolution 912 and the Current Regulation of Dietary Supplements

Dietary supplements are extensively regulated under several federal state and local authorities. Since the 1938 passage of the Food, Drug and Cosmetic Act, the United States Congress has directed the Food and Drug Administration (FDA) to regulate dietary supplements as a subcategory of "foods." The Dietary Supplement Health and Education Act of 1994 (DSHEA) reaffirmed the congressional mandate that dietary supplements be regulated as foods, and strengthened FDAœs regulatory authority.

In 1994, after extensive review and numerous Congressional hearings, the U.S. Congress concluded that consumers should continue to have access to safe dietary supplement products made to quality standards, and to accurate, truthful, and non-misleading information about them. Congress based its decision on science-based information that conclusively showed the need, benefits, and safety for these products when used properly.

Other laws, such as the Nutrition Labeling and Education Act (NLEA, 1990) and the FDA Modernization Act (FDAMA, 1997) also maintain the regulation of supplements as foods. Under these Acts: (1) FDA sets the format for label content, (2) FDA requires approval for nutrient content claims, (3) FDA pre-authorizes health claims, (4) FDA can declare products misbranded or adulterated, (5) FDA may disapprove a supplement manufacturerœs notification on the safety of new ingredients, (6) FDA may establish specific good manufacturing practices (GMPs) for dietary supplements, (7) FDA may take enforcement action against a dietary supplement manufacturer making unsubstantiated "structure-function" label statements, and (8) FDA conducts inspections of production facilities. FDA enforces these laws with civil and criminal penalties.

The FDA Commissioner Jane Henney, M.D. has indicated that FDA has adequate legal authority to regulate dietary supplements. At her Senate confirmation hearing, Commissioner Henney stated, "To the best of my knowledge DSHEA provides adequate statutory authority to protect the public health." She concluded, "I have no plans to seek additional authority over dietary supplements."

To underscore FDAœs perspective, FDA has recently released its long-term strategic plan that recognizes DSHEA and the regulation of dietary supplements in the context of DSHEA as a subcategory of food. CRN has pledged to be a part of a public/private partnership with FDA and other interested parties to identify priorities within FDAœs initiative and to seek resources to help build the internal infrastructure for the appropriate enforcement of FDAœs regulations.

Another federal agency, the Federal Trade Commission (FTC), requires all dietary supplements advertising to be truthful, not misleading and substantiated by scientific evidence. FTCœs broad regulatory powers and vigorous enforcement over the last several years have demonstrated this authority.

 

Introductory Bill No. 583— Posting of Warnings

CRN believes it would be highly inappropriate and counterproductive to require the posting of signs advising consumers to seek medical advice when taking dietary supplements. Imagine having to make an appointment with your physician and then having to spend your hard-earned dollars or tax dollars to ask the physician, "Is it okay to take these multivitamins?" Or, "Is it okay to follow the recommendations made by the March of Dimes, the Centers for Disease Control and Prevention, and dozens of organizations of health professionals that urge women of childbearing age to take a multivitamin with folic acid to help prevent neural tube birth defects?"

The proposed bill, as written, would affect these and scores of other widely used products. This requirement could harm the public health by frightening people from using other beneficial products like calcium, vitamins C and Eºnutrients known to reduce the risk of debilitating and deadly diseases. The signage requirements that would be placed on the thousands of retail establishments in New York City would discourage women of childbearing age from taking multivitamins to reduce the risk of neural tube birth defects. These signs would falsely imply that this safe, helpful, FDA pre-authorized health claim might present a safety problem.

Letœs look a little further at the negative impact that these signs could have. Children, teenagers and young adults need more calcium than they usually get from their diets to build strong bones and to help protect against osteoporosis later in life. Middle-aged adults and older Americans need calcium to slow the rate of bone loss, thus protecting against the risk of debilitating fractures from osteoporosis. They should not be deterred by warning signs posted above shelves of calcium supplements, falsely implying that some harm might come from their efforts to protect their bones.

Also, botanical supplements such as St. Johnœs wort and gingko biloba are supported by extensive clinical research, and their effects are so promising that the National Institutes of Health (NIH) is funding major research programs on these supplements. The entire area of botanicals shows so much potential that NIH has recently authorized $7.5 million in grants to establish two major botanical research centers at UCLA and the University of Illinois. An additional center will be established later this year. Botanicals are recognized worldwide for their health benefits, and are in the process of becoming better understood by American consumers. Extensive monographs document both safety and value for the botanical products that are of greatest interest in the U.S. market. The proposed warning signs would be inappropriate for botanical supplements as well.

The more appropriate approach is to place the responsibility on the manufacturer to provide the consumer with accurate, timely, useful, science-based information on which to base marketplace decisions. Responsible authorities should ensure that this information is substantiated. This is a more appropriate role for the government to play.

Introductory Bill No. 583—Ephedra

Bill Number 583 was proposed in response to concerns about products containing ephedra or ephedrine alkaloids. Most ephedra-containing products on the market already bear warnings against the use of such products by minors. CRN and other dietary supplement associations have been working with FDA since 1993 to develop appropriate cautions to consumers, as well as dosage limits for ephedra-containing products. Today, virtually all products now bear extensive informative statements consistent with the one proposed by FDA.

In response to recent Congressional criticism of FDAœs lack of science behind its proposed restrictions, CRN is contracting with experts in toxicology to assess ephedra safety in greater detail than ever done before, using the well recognized scientific principles of quantitative risk assessment developed by the venerable U.S. National Academy of Sciences.

CRN urges the City Council of New York also to take a balanced and scientific approach to dealing with these products in a way that will protect the public and not do unintended harm.

Maintaining a Broad Public Health View

CRN and its member companies supply safe and beneficial dietary supplements to probably several million New York consumers on a daily basis. CRN understands the special issues that exist with the marketing of products with stimulant ingredients such as ephedra, and CRN supports the current widely used warnings and scientifically based dosage limits for such products. However, it is critical that these concerns be dealt with in context, without harming the public health by inappropriately undermining consumer confidence in the entire dietary supplement category or in the regulatory system that governs the safety and labeling of all supplements.

Madam Chair, as I close my brief remarks, I return to my original objective to cover three basic points. First, dietary supplement products are extensively regulated and should be used by consumers as directed. Second, ephedra dietary supplements are appropriately marketed to consumers, including voluntary industry self-regulating labeling information. And third, the New York City Councilœs resolution and bill most likely will scare people away from using supplements that are known to enhance their health and well being, and thus, these proposals will be counterproductive.

FDAœs new initiative and the dietary supplement industryœs desire to work with the agency underscore the joint responsibilities that the manufacturers and the regulators have in helping to continue to ensure consumer confidence in these healthful products. Consumers also have a responsibility. That responsibility begins with the consumer becoming as informed as possible and following the label directions of dietary supplements.

I recognize that I have had to cover these points rather quickly, so I wish to leave, for the record, several documents that provide more details on these matters. These materials have been substantially prepared by CRNœs scientific and regulatory group.

Thank you.

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DOCUMENTS PROVIDED BY CRN:

Annette Dickinson, Ph.D. Before & After DSHEA. The regulation of dietary supplements before and after the Dietary Supplement Health and Education Act of 1994. Council for Responsible Nutrition, Washington, D.C., 1999.

Marilyn Barrett, Ph.D. Reference on Evaluating Botanicals. Council for Responsible Nutrition, Washington, D.C., 1998.

Annette Dickinson, Ph.D. Optimal Nutrition for Good Health: The Benefits of Nutritional Supplements. Council for Responsible Nutrition, Washington, D.C., 1998.

John N. Hathcock, Ph.D. Vitamin and Mineral Safety. Council for Responsible Nutrition, Washington, D.C., 1997.

Regulations At A Glance Council for Responsible Nutrition, Washington, D.C., 1999.