Dear Ms. Axelrod:

     This letter reflects our comments on the draft recommendations of the Commission from November 16, 2001 that pertain to dietary supplements. It supplements our October 29, 2001 letter to Dr. Gordon regarding our position on nutrition policy.

     We wish to commend the White House Commission on Complementary and Alternative Medicine for recommending that dietary supplement manufacturers register with the Food and Drug Administration (FDA) and report serious adverse events to the agency. In July 2000, the General Accounting Office concluded that:

Once products reach consumers, FDA lacks an effective system to track and analyze instances of adverse effects. Until it has one, consumers face increased risks because the nature, magnitude and significance of safety problems related to consuming dietary supplements and functional foods will remain unknown.¹

     Similarly, a report by the Office of Inspector General (IG) of the Department of Health and Human Services, Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, concluded that "FDA receives less than 1 percent of all adverse effects associated with dietary supplements"² under its voluntary reporting system. This under-reporting is particularly problematic because, as the IG explained, dietary supplements do not undergo premarket approval for safety and efficacy, and the adverse event reporting system is the FDA’s primary means for identifying safety problems.³ The IG, therefore, recommended that manufacturers be required to report serious adverse events to the FDA.

     We urge the Commission to also support mandatory registration of supplement manufacturers and their products as called for by the IG.⁴ Currently, the FDA lacks a registry of dietary supplement manufacturers, packers and distributors, the products they produce, pack or distribute, and the ingredients contained in each product. These problems impede effective investigation and appropriate and expeditious responses to reports of adverse events associated with particular supplement ingredients.

     In recognition of the insufficiency of FDA’s adverse event reporting system, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2002 provides an increase of $1,500,000 for dietary supplement adverse event monitoring.⁵ The legislation does not, however, authorize FDA to establish a mandatory adverse event reporting system. Rep. Susan Davis (D.-CA) has, however, introduced legislation (H.R. 3065) that would require dietary supplement manufacturers to register with the FDA and report serious adverse experiences to the Agency.

     The legislation would also provide the FDA with additional inspection authority to view manufacturers’ records of adverse experiences. Currently, manufacturers have no statutory obligation to provide safety information to the FDA, and the FDA has no statutory authority to review company records, including customer complaints of adverse experiences, during inspections.⁶ This authority is crucial. In one private lawsuit alone, it was demonstrated that a dietary supplement company had some 3,500 complaints about its product of which the FDA was unaware.⁷ We thus urge the Commission to call for enactment of the provisions in this legislation.

     CSPI also believes that it is essential that the most commonly used supplements, those that pose serious risks, and those that may adversely affect vulnerable populations (pregnant and lactating women, young children and the elderly) be subject to systematic review of safety and effectiveness. Currently the National Academy of Sciences Institute of Medicine, pursuant to an FDA grant, is in the process of developing a framework for evaluating the safety of dietary supplements and will be creating six model monographs. We urge the Commission to recommend that Congress expand the NAS study to cover significantly more supplements and to encompass supplement efficacy.

     Finally, we urge the Commission to recommend that the FDA actively enforce the law to prohibit misleading claims for dietary supplements. Congress appropriated $500,000 to the FDA for "dietary supplement activities relating to enforcement purposes."⁸ It also provided $500,000 to the Office of General Counsel for "enforcement of violations of DSHEA’s labeling and content requirements."⁹ Manufacturers will not be deterred from violating DSHEA unless the FDA begins to actively enforce its requirements. Hence, we urge the Commission to recommend prompt FDA action in this area.

Sincerely,

References

1. General Accounting Office, FOOD SAFETY Improvements Needed in Overseeing the Safety of Dietary Supplements and "Functional Foods," (GAO/RCED-00-156 July 2000) at 26.

2. Department of Health and Human Services, Office of Inspector General, Adverse Event Reporting for Dietary Supplements (OEI-01-00180 April 2001) at ii.

3. Id. at 1.

4. Id. at iv.

5. H.R. Rep. No. 107-275, at 82 (2001).

6. FDA has this authority for both prescription and nonprescription drugs. FDCA § 704(a)(1), 21 U.S.C. § 374(a)(l).

7. Linda Shrieves, Ephedra Exposed, Orlando Sentinel, Oct. 23, 2000 at A6.

8. H.R. Rep. No. 107-275, at 82 (2001).

9. Department of Labor, Health and Human Services and Education and Related Agencies Appropriations Act, 2002, H.R. Rep. No. 107-342, at 112 (2001).