Looking back at the Vitamin Volstead Act, DSHEA, Codex, the AER Bill, and MPLs
By James J. Gormley, Gormley NPI Consulting, CFH President and Senior Policy Advisor
This post first appeared on Nutraceuticals World, reposted with permission
Retailers, consumers, and natural products industry stakeholders have a history of generally—although not exclusively—uniting for what they considered the common good against regulation that could restrict consumer access and harm the industry, and in favor of legislation that would improve access and strengthen the industry.
One early unifying battle was for the ultimate passage of the Hosmer-Proxmire “Vitamin Bill.”
The Hosmer-Proxmire Vitamin Bill
On Jun. 18, 1966, the U.S. Food and Drug Administration (FDA) announced onerous vitamin and mineral regulations that would have banned nutrient potencies above 100% of the RDAs by classifying those products as drugs, in addition to labeling requirements that would have eliminated most useful information.
The response was a sustained battle led by the National Nutritional Foods Association (NNFA)—now the Natural Products Association (NPA)—that unified consumers, retailers, and manufacturers.
The war was waged via many coordinated efforts, including a postcard-writing campaign that was supported by a full-page ad in the Washington Post denouncing the FDA’s attempts to resurrect “Prohibition” but, in this case, directed to most dietary supplements. This is why the FDA’s proposed regulations were referred to by its opponents as the “Vitamin Volstead Act.”
The industry’s rallying cry was: “PROTECT us NOT from that which is GOOD!” Ultimately the industry and consumers won this battle on Apr. 22, 1976 when the Hosmer-Proxmire Vitamin Bill—which eliminated these proposed regulations—was signed into law.
At the time, retailer Max Huberman and industry attorney Milton Bass wrote: “This landmark legislation is the greatest victory for the health-food industry and consumers ever achieved.”
The Dietary Supplement Health and Education Act (DSHEA)
Fast-forward to the 1990s. Lobbyist Jack Martin said in a 2007 interview with Suzanne Shelton that, “The catalyst for DSHEA was the enforcement activities of FDA and the possible impact of the regulations that were being written for NLEA [the Nutrition Labeling and Education Act of 1990].”
According to Martin, although there was an enormous uproar over FDA actions relating to black currant oil, he noted that, “The final spark was a direct result of the regulations being written for the NLEA.” According to Martin: “These regs would have made it almost impossible to educate any consumer about the benefits of dietary supplements.”
If that was the spark, arguably the blaze that mobilized a nation was the “Tahoma Clinic Raid” on May 6, 1992. In this raid, the FDA stormed Dr. Jonathan Wright’s clinic with armed sheriffs who seized vitamins, equipment, and medical records, in the process reportedly frightening both patients and staff. Anger about, and fear of, these shock-and-awe tactics spread like wildfire across the U.S.
Retailer Joe Bassett and the northwest region of the NNFA expanded an early incarnation of Citizens for Health (CFH) in order to galvanize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Dr. Alexander Schauss, Craig Winters, and others.
Champions of DSHEA included (but were not limited to) Milton Bass, Scott Bass, Hal Drexler (founder of Country Life Vitamins), Loren Israelsen, Patrick Mooney (co-founder of Super Nutrition USA), Jarrow Rogovin (founder of Jarrow Formulas), and Jim Turner.
In fact, the Council for Responsible Nutrition (CRN), NNFA, the Utah Natural Products Alliance (UNPA)—now the United Natural Products Alliance—Citizens for Health and others, all working together, enabled the passage of DSHEA in October 1994.
While the biggest battles in which industry members have fought together have largely been fights for more freedom and less restrictive regulation, other issues have not consistently unified industry and consumers, such as Codex Alimentarius, the European Food Supplements Directive and the AER Bill.
Codex and the European Food Supplements Directive
The lead-up to the Codex Alimentarius Commission adoption of the Guidelines for Vitamin & Mineral Food Supplements in July of 2005 polarized much of industry vs. many consumer groups.
In a nutshell, industry’s position could be summarized, as follows:
- Government and industry cooperated and came up with a science-based approach to setting upper limits for vitamin and mineral supplements.
- The stage is now set for science-based implementation of the European Food Supplements Directive (EFSD) & other Directives.
- We now have a risk assessment model for supplements.
- Now countries can rest assured that vitamins and minerals are safely regulated in trade.
- Worldwide consumers are now protected.
The consumer-advocacy position could be summarized in this way:
- Industry gave in to the pressure of Germany and the EU bloc and wants vitamin and mineral guidelines that will be considered binding by the World Trade Organization (WTO) and international treaties. Cross-recognition of these guidelines may potentially lead to the FDA’s harmonization of its regulations, via amendments and Congressional rulemaking, with international standards.
- Is a toxic chemical/industrial hazards risk assessment model appropriate for dietary supplements?
- Considering that U.S. consumers are already protected, and that most overseas consumers are already over-protected by standards that regulate supplements as drugs, why do worldwide consumers need a web of international regulation added on to what is already regulated by individual nations and blocs of nations (e.g., the EU)?
Contrary to misinformation from certain consumer groups at the time, U.S. law regulating dietary supplements remained unchanged by the guidelines. In addition, the guidelines did not create a “prescription only” market for any nutrients, especially the broad category of dietary supplements, since the initial guidelines only addressed several dozen essential nutrients and no herbs.
It was the position of most of the natural products industry, then, that the establishment of upper-level nutrient limits must be based on the preponderance of scientific research, not modelled on low-dose RDAs or on poorly conducted studies.
Ultimately, the industry remained on course and consumers did not have their supplements taken away, although some U.S. manufacturers that sell internationally had to reduce dosage levels for, or remove, certain ingredients.
The Adverse Event Reporting (AER) Bill
In 2006, the proposed Dietary Supplement and Non-Prescription Drug Consumer Protection Act (aka “the AER bill”) did have widespread, although not universal, support.
Some industry companies strongly backed the bill, others offered conditional support, while still others mounted aggressive anti-AER bill campaigns.
In fact, a coalition of industry led by CRN and the Natural Products Association, joined by a powerful contingent of grassroots consumer groups (including Citizens for Health), enabled the passage of this bill at about 3 a.m. in an early December 2006 morning … by one vote.
On Dec. 22, 2006, President George W. Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act into law, which was regarded by many as a victory for consumers and the responsible core of the industry.
“The MPL controversy has unarguably divided the industry in a way that perhaps few issues have over the last 50 years.”
Mandatory Product Listing (MPL) for Dietary Supplements
Much more recently, a proposed mandatory product listing (MPL) for dietary supplements has divided industry right down the middle, with the Natural Products Association, the American Herbal Products Association, and a consumer grassroots campaign—led by Citizens for Health and the Alliance for Natural Health—against mandatory product listing language.
On the other side of the issue were the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA), both of which have been champions for MPL.
Ultimately, provisions that would have established a mandatory product listing requirement for dietary supplements marketed in the U.S. were not included in the $1.7 trillion omnibus government funding bill that was signed into law on Dec. 29, 2022.
Sen. Dick Durbin (D-IL), who along with Sen. Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022, has vowed to keep pushing for MPL legislation in the 118th Congress.
The MPL controversy has unarguably divided the industry in a way that perhaps few issues have over the last 50 years.
While it remains to be seen what will unite or divide the natural products industry in 2023, industry members will likely have opportunities to find common-ground issues around which to unify.
About the Author: Nutraceuticals World has invited James to write a quarterly column, called Natural Products Insights, a series of which this article is the first. Mr. Gormley has been an award-winning natural products industry writer, editor and thought leader since 1995. The head of Gormley NPI Consulting, as well as President and Senior Policy Advisor of Citizens for Health, he can be reached via his website, JamesGormley.com or via e-mail at email@example.com.