In 1971, a federal court expressed the rationale behind the federal Food, Drug, and Cosmetic Act when it wrote that the law was "enacted for the protection of an otherwise helpless consumer public" [United States v. Lit. Drug Co., 333 F.Supp. 990, 998 (D.N.J. 1971)]. But would consumers be helpless without the Food and Drug Administration certifying the safety and effectiveness of drugs, biologics, and medical devices? A recent National Public Radio report suggests the answer is no.
The one area where Congress has reined in the FDA's regulatory authority has been dietary supplements. The FDA has no authority to regulate the content or safety of dietary supplements before those products are sold. Since the FDA doesn't require testing, there is no testing. Right?
Wrong. A for-profit firm called ConsumerLab.com tests dietary supplements with an eye toward catching unsafe or mislabeled products in the lab before they harm anyone. ConsumerLab.com provides reports on its findings to consumers who pay an annual fee, but it provides information on product recalls at no charge.
According to the firm's web site:
ConsumerLab.com, LLC ("CL") is the leading provider of independent test results and information to help consumers and healthcare professionals evaluate health, wellness, and nutrition products. It publishes results of its tests at www.consumerlab.com — which receives nearly 2 million visits per year, in its acclaimed book ConsumerLab.com's Guide to Buying Vitamins & Supplements, and in special technical reports. Its research is cited frequently in the media, books, and at medical meetings. As a certification company, CL enables companies of all sizes to have their products voluntarily tested for potential inclusion in its list of Approved Quality products and bear the CL Seal. In the past five years, CL has tested more than 1,200 products, representing over 250 different brands and nearly every type of popular supplement.
ConsumerLab.com was launched by William Obermeyer, a former FDA official whose job it was to test these products after problems emerged. When Obermeyer realized he could do more good by testing these products ex ante, he quit his day job and helped create ConsumerLab.com.
Some have argued that allowing dietary supplement manufacturers to pay for the review that determines whether the CL Seal will go on a product creates a conflict of interest. Yet the value of the "CL Seal" depends on ConsumerLab.com's reputation for independence. NPR reports, "There are no indications that this has created any bias." (Besides, many see indications of bias at the FDA itself, even when the agency's funding does not come from private parties.)
So it is not the case that the FDA is an indispensable agency. It performs an indispensable function. But if it disappeared tomorrow, private organizations would meet (1) consumers' demand for independent product reviews and (2) producers' demand for credible quality signals. And those private organizations would have to compete with each other on the basis of thoroughness and integrity. As NPR reports:
ConsumerLab.com isn't alone in testing supplements. Another logo beginning to appear on labels is a blue NSF mark, which signals that a product has been certified by the National Sanitation Foundation.
And it doesn't stop there. Other private organizations that set quality standards or evaluate the quality of various goods and services include:
- Accreditation Council for Continuing Medical Education (physicians)
- Accreditation Association for Ambulatory Health Care, American Association for Accreditation of Ambulatory Surgery Facilities, Joint Commission on Accreditation of Healthcare Organizations (health care facilities)
- American Gem Society, Gemological Institute of America (jewelry)
- American National Standards Institute (standards-developing organizations)
- Clinical and Laboratory Standards Institute
- Consumer Reports (everything under the sun)
- Consumers CHECKBOOK (everything under the sun, including federal employees' health plans)
- Good Housekeeping Institute & Good Housekeeping Seal Directory (consumer products)
- HealthGrades, WebMD, Subimo (physicians, hospitals, and nursing homes)
- Insurance Marketplace Standards Association
- Sporting Arms and Ammunition Manufacturers' Institute (firearms, ammunition, and components)
- Underwriters Laboratories (the big cheese; thousands of potentially dangerous products, including dozens that you use every day)
- United States Pharmacopeia Drug Information ("off-label" uses of pharmaceuticals)
- Worstpills.org (information on pharmaceuticals for those who think the FDA's standards are too lax)
Read more about a world without the FDA.