History
From Harvey Wiley to today
A cited timeline of how food and drug protections were built, and how they have been narrowed for supplements. For the story behind our name, see the short essay below.
Timeline
- Protection added
- Protection narrowed
- Enforcement or state action
Protection added
Harvey Wiley becomes USDA's chief chemist
Wiley expands the Bureau of Chemistry's studies of food adulteration and campaigns for a federal law.
FDA History Office: Milestones in U.S. Food and Drug Law · FDA: Harvey Wiley
Protection added
The "Poison Squad" studies begin
With $5,000 from Congress, Wiley's volunteers eat measured amounts of common preservatives (borax, salicylic acid, formaldehyde, saccharin, sodium benzoate, copper sulfate) to test whether they are safe. The trials run for about five years.
Library of Congress: Harvey Wiley and the Pure Food Movement · FDA Consumer: Harvey W. Wiley, Pioneer Consumer Activist (PDF)
Protection added
The Pure Food and Drugs Act
The first federal law against misbranded and adulterated foods and drugs, and the first to prohibit false or misleading statements on food labels. Wiley's bureau enforces it.
FDA History Office: Milestones in U.S. Food and Drug Law · Library of Congress: Harvey Wiley and the Pure Food Movement
Protection narrowed
Wiley is overruled, then leaves
After disputes over saccharin and preservatives such as benzoate, a Referee Board of outside scientists led by Ira Remsen (a co-discoverer of saccharin) is appointed to redo Wiley's work and reaches different conclusions. Wiley resigns from government in 1912.
FDA: Harvey Wiley · FDA History Office: Sugar, A Cautionary Tale (PDF) · FDA Consumer: Harvey W. Wiley, Pioneer Consumer Activist (PDF)
Protection added
After a deadly elixir, a stronger law
In 1937, Elixir Sulfanilamide, made with the poisonous solvent diethylene glycol, killed 107 people, many of them children. The 1938 Federal Food, Drug, and Cosmetic Act requires new drugs to be shown safe before they are sold.
FDA: Sulfanilamide Disaster · FDA History Office: Milestones in U.S. Food and Drug Law
Protection narrowed
Food Additives Amendment, with a GRAS exception
New food additives need FDA approval before use, except substances "generally recognized as safe" (GRAS) by qualified experts. That exception becomes a major route for new ingredients to reach the market.
FDA: Generally Recognized as Safe (GRAS) · FDA History Office: Milestones in U.S. Food and Drug Law
Protection narrowed
The Proxmire Amendment
The Vitamins and Minerals Amendments stop FDA from limiting the potency of vitamins and minerals in supplements, or from regulating them as drugs based on potency alone.
Protection narrowed
The Dietary Supplement Health and Education Act (DSHEA)
Supplements are classed as food. There is no pre-market approval: companies can sell most supplements without showing FDA they are safe or contain what the label says, and FDA carries the burden of proving a product unsafe after it is sold.
FDA History Office: Milestones in U.S. Food and Drug Law · Congress.gov: S. 784 (103rd Congress) · FDA: Information for consumers on using dietary supplements
Protection narrowed
GRAS becomes voluntary notice
FDA proposes in 1997, and finalizes in 2016, a system in which companies may notify FDA of their own GRAS conclusions. Notification is voluntary, so a company can decide an ingredient is safe without telling FDA.
Federal Register: 62 FR 18938 (April 17, 1997) · Federal Register: 81 FR 54960 (August 17, 2016)
Enforcement or state action
Ephedra banned, years after reports of harm
FDA declares supplements with ephedrine alkaloids adulterated because they present an unreasonable risk, citing a growing number of adverse events. It is the first ban of a supplement ingredient under DSHEA.
Federal Register: 69 FR 6788 (February 11, 2004) · FDA History Office: Milestones in U.S. Food and Drug Law
Protection narrowed
Food Safety Modernization Act
FSMA gives FDA new food-safety powers, including mandatory recall authority. It does not add pre-market review or mandatory product listing for dietary supplements.
FDA History Office: Milestones in U.S. Food and Drug Law · Congress.gov: H.R. 2751 (111th Congress)
Protection narrowed
Kratom scheduling announced, then withdrawn
DEA announces its intent to temporarily place mitragynine and 7-OH in Schedule I (August 31), then withdraws the notice (October 13) and opens a comment period.
Federal Register: 81 FR 59929 · Federal Register: 81 FR 70652
Enforcement or state action
Federal action on concentrated 7-OH
FDA announces warning letters to seven firms selling concentrated 7-OH (July 2025). HHS recommends Schedule I thresholds (October 8, 2026), and DEA publishes a notice of intent to temporarily schedule 7-OH and MGPI above those thresholds (October 14, 2026, Docket DEA-1570).
FDA press announcement, July 15, 2025 · HHS threshold recommendation · Federal Register: 91 FR 65370
Enforcement or state action
21 states have acted; federal supplement law has not changed
13 states have banned or scheduled concentrated 7-OH and 8 more have passed limits. DSHEA's basic design, with no pre-market safety review and no required product listing, is still in place.
What The Wiley Rule asks for now: list every product, require an honest label, and prove new ingredients are safe before they reach a shelf. Read our policy platform.
The name
Why we call it the Wiley Rule
In 1902, a government chemist named Harvey Wiley asked a simple question: what are these new chemicals in our food doing to us? He fed measured doses to twelve young volunteers, the “Poison Squad,” and the country listened. In 1906, Congress passed the Pure Food and Drug Act, often called the Wiley Act. For the first time, labels had to tell the truth, even about opium and morphine.
Over the next fifty years we added a second promise: show it’s safe before you sell it. In 1994, that promise was loosened for supplements. Newer consumer products—like concentrated 7-OH tablets, shots and vapes sold in smoke shops, convenience stores and online—have exploited those and related regulatory gaps, even though FDA has said concentrated 7-OH products are not lawful dietary supplements or foods.
The Wiley Rule is simple: if it goes in our bodies, prove it’s safe and say what’s in it.
Three pillars
- 1
Say what's in it
Honest labels with milligram amounts, and a public list of every product.
- 2
Prove it's safe first
For what's new or potent: safety evidence before it reaches a shelf.
- 3
No loopholes, kids protected
One rule for every form, 21 and over, child-safe packaging.
Safety and honesty, not blanket bans: traditional vitamins, minerals and long-used botanicals stay as they are. Read our policy platform.
Portrait: Harvey W. Wiley, photographed by Harris & Ewing. Library of Congress, Prints and Photographs Division (LCCN 2016862478), public domain, via Wikimedia Commons.