“Without Proxmire, it’s unlikely there would have been a DSHEA because there wouldn't have been much of an industry,” said Loren Israelsen, president and founder of the United Natural Products Alliance and one of the architects of DSHEA. “There would have been no growing consumer base that wanted to protect access to supplements.”
On July 15, 1975, Sen. William Proxmire introduced a hard-fought bill to prevent the Food and Drug Administration (FDA) from regulating vitamins and minerals as drugs. The amendments passed Congress with an overwhelming majority in April 1976 and were signed into law shortly thereafter. They are now encoded as Section 411 of the Food, Drug, and Cosmetic Act and served as a blueprint for much of DSHEA but are better known as the Proxmire Amendments.
Born in Lake Forest, Illinois and a graduate of both Harvard and Yale, Sen. Proxmire replaced the recently deceased Sen. Joseph McCarthy as the senator from Wisconsin in 1957 and ran for re-election the following year with the slogan “The Senator who keeps his promises."
During his 32-year tenure in Congress, he opposed wasteful government spending, fought against sales tax, championed an international treaty banning genocide, defended dairy farmers, disputed space exploration, pushed for regulation of the credit life and disability insurance industries, worked to prevent the big business squeeze on small business and rallied relentlessly to protect people’s right to health freedom.
In his personal life, he was known for keeping up health and appearance—with daily five-mile runs to work on Capitol Hill, a regimented diet, his sharp black-suit-and-skinny-tie uniform, and eventually a facelift and hair transplant.
The road to the amendments
The story of how the amendments came to be can be traced to 1941 when the FDA adopted regulations governing label statements for dietary properties of foods represented as being for special dietary use and established minimum daily requirements (MDRs) for vitamins and minerals.
A mini renaissance of the vitamin and mineral industry followed, with a growing assortment of products and claims as business blossomed over the next two decades.
In the 1960s, however, FDA called for a review of the 1941 regulations to rein in the expanding industry with the establishment of Recommended Daily Allowances (RDAs) for protein, 12 vitamins and seven minerals and an initiative that would restrict the amount of each vitamin in any product to 150% of the RDA.
The proposal also endeavored to limit the combinations of vitamins that could be marketed as dietary supplements and to include a disclaimer on label that read: "Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements."
After a series of hearings between 1968 and 1970, FDA abandoned the disclaimer, but the RDA restrictions passed in 1973, which would have required approval of vitamins and minerals by an FDA over-the-counter (OTC) expert advisory committee before entering the market, much like OTC drugs.
Scheduled to go into effect July 1, 1975, the law set off a wave of protests from consumers, supplement companies and their representatives, bolstered by a mammoth letter-writing campaign said to have generated more letters to Congress than Watergate at the time.
“Perhaps the most influential player was the senior senator from Wisconsin, a vitamin enthusiast himself who did not suffer what he considered government waste,” wrote FDA historian John Swann in a 2015 paper published in the journal Drug Testing and Analysis. “William Proxmire, convinced that the FDA had sufficient power to remove toxic or misbranded supplement products from the market without infringing on the public's right of access to vitamins and minerals, led the way in passing the Vitamin-Mineral Amendments of 1976.”
While Sen. Proxmire accused the FDA of attempting to overreach its powers, the Agency predicted there would be “widespread consumer fraud and unchecked quackery” unless its new regulations went into effect, The New York Times reported on Aug. 15, 1974.
What’s in the amendments
Presented under “Title V—Federal Food, Drug, and Cosmetic Act Amendments” of Public Law 94-278 of the 94th Congress on April 22, 1976, the update prohibited the FDA from limiting the potency of vitamins and minerals in food supplements or from regulating them as drugs based solely on potency.
It also prevented restrictions on the combination or number of synthetic or natural vitamin, mineral or other food ingredients in products—with the caveat that they would not be represented for use in the treatment or management of specific diseases or disorders, by children under the age of 12, or by pregnant or lactating women.
The law did however stipulate FDA’s new authority to pursue actions against mislabeled and misbranded supplements. In the case of misleading or false advertising, the Agency could claim enforcement rights if the Federal Trade Commission first declined to act, or if a product or its advertising represented an imminent health hazard. Here, Congress indicated that FDA should issue a written notice or warning in lieu of judicial action when the Agency believed it would adequately protect the public interest.
The definitions within also established 'food for special dietary use' as being or containing any natural or synthetic vitamin or mineral and which "(i) is intended for ingestion in tablet, capsule or liquid form, or (ii) if not intended for ingestion in such a form, does not simulate and is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet." It also specified 'special dietary use' as "supplying a vitamin, mineral or other ingredient for use by man to supplement his diet by increasing the total dietary intake."
"So, it's the concept of increasing total dietary intake that allows the consumer, through their intended use, to decide what nutrients or dietary ingredients are important for their diet," Israelsen explained, noting that both of these elements were incorporated into the writing of DSHEA nearly 20 years later.
The amendments entered the Federal Register on Oct. 19, 1976 and were scheduled to go into effect on Jan. 1, 1978 to allow time for any relabeling required, including the disclaimers for infants, children and pregnant or lactating women.
‘They don't like that law at the FDA’
An article in the July-August 1976 issue of FDA Consumer, the Agency’s monthly magazine from 1967 to 2007, summarized the implications of the law, acknowledging it as setback for FDA and its ongoing push to impose tighter regulations on the industry to impact dietary supplement use.
“In passing the law, Congress has made it clear that FDA should not attempt to provide economic protection for consumers by regulating vitamin and mineral supplements solely because they contain dosages the Agency believes are greater than the body needs or can use, or because they contain added substances that the Agency believes are nutritionally useless,” wrote Harold Hopkins, the magazine’s editorial director.
Social historian James Harvey Young, in a chapter for a 1978 Nutrition Foundation monograph, recounted that during the course of the legislative adventure, then FDA Commissioner Alexander M. Schmidt described the amendments as “a charlatan’s dream."
He also noted the lack of public hearings on the bill despite opposition from groups including the American Society of Clinical Nutrition, the Committee on Nutrition of the American Academy of Pediatrics, the American Association of Retired Persons, Consumers Union and Ralph Nader's associates.
“The 1976 amendments to the 1938 act represent the first retrogressive step in federal legislation respecting self-treatment wares since the initial Pure Food and Drugs Act became law in 1906,” Young, a firm believer in government regulation of food and drugs, went on to write.
Nearly six months to the day after the amendments passed, FDA presented revised vitamin–mineral regulations, which included restrictions on the composition of certain dietary supplements like high potency preparations of vitamins A and D and folic acid on the basis of safety.
A court challenge followed, however, and the judge ruled on procedural grounds that with the adoption of the Proxmire Amendments, “Congress effected a profound alteration in an agency's powers while rulemaking was in progress” (National Nutritional Foods Association v. Kennedy). The FDA reluctantly revoked its regulations in 1979.
In a 1988 article published in The Washington Post, Stephen McNamara, a lawyer with Hyman, Phelps & McNamara and another key contributor to DSHEA, looked back at the Proxmire Amendments as the industry geared up to fend off another wave of FDA clamp down, this time over labeling claims.
"They don't like that law at the FDA,” he is quoted as saying. “They don't want to talk about it, and they do their best not to think about it."