Policy platform
The Wiley Rule, in plain words
Our platform has one idea behind it: if it goes in our bodies, prove it’s safe and say what’s in it. Here is what that means for the law.
Why this matters. The Dietary Supplement Health and Education Act of 1994 (DSHEA) lets most supplements go on sale without being registered, tested or shown to be safe. FDA usually acts only after harm is reported. Concentrated 7-OH products—typically sold as consumer items in smoke shops, convenience stores, gas stations and online, and that FDA has said are not lawful dietary supplements or foods—have shown how products can exploit those regulatory gaps.
What we ask Congress to change
1. List every product before it is sold
Require every dietary supplement to be registered with FDA, with its full label, ingredients and maker, in a public database. Today FDA often doesn't know a product exists until someone is hurt.
2. Say exactly what's in it
Labels must list every active ingredient with its amount in milligrams per serving, with no "proprietary blends" hiding the dose. A product's contents must match its label within a set margin.
3. Test for adulterants, and let FDA recall
Makers must test each batch for undeclared drugs, synthetic or lab-altered compounds and contaminants, and keep the results. FDA should have clear authority to order a mandatory recall and see a company's records, as it does for food.
4. Report serious harm, for every product
Every company that sells a supplement must report serious adverse events to FDA, and FDA should publish what it receives in a searchable form.
5. Prove new ingredients are safe first
Enforce the existing new-ingredient safety notice, and treat lab-made or chemically concentrated versions of plant compounds as new ingredients that need safety evidence before sale.
6. Protect kids
A national 21-and-over age limit for kratom and 7-OH type products, child-resistant packaging, and no packaging or flavors designed to appeal to children.
What we ask states to do now
States can move faster than Congress, and more than twenty already have. See the state-by-state list.
A. Ban concentrated 7-OH and lab-made alkaloids
Prohibit the sale of products with 7-OH, MGPI, MGM-15, MGM-16 and similar synthetic or semi-synthetic alkaloids above a trace threshold, in every form, including vapes, shots and tablets.
B. 21 and over
No sales of kratom-derived products to anyone under 21, with ID checks and real penalties for sellers who don't.
C. Honest labels and a state product list
Require registration of kratom products sold in the state, lab testing by an accredited lab, and labels that list alkaloid amounts.
D. Fund enforcement and education
Give state agencies the tools to test products and remove illegal ones, and fund plain-language education for parents and schools.
We are drafting model state bill language to go with these asks. Read the draft.
What we don't ask for
We are not asking to ban vitamins, minerals or long-used botanicals, and we don’t want to punish people who use or struggle with these products. People who need help should get care, not a criminal record.