THE MIDLIFE REVIEW · INVESTIGATION

In 1994, the U.S. Government Nearly Banned Every Herbal Supplement in America. Here's What They Didn't Want Women Over 45 to Know.

An investigative look at the 1993 FDA proposal, the letter campaign that stopped it, the law that passed without a single recorded no vote — and the five plants that came out the other side. The story below.
By Carolyn ReevesHealth & midlife · The Midlife Review · today
In short:In 1993 the FDA floated rules that critics said would have pulled most herbs off the shelf. Ordinary people wrote to Congress until it stopped. The plants survived. What did not survive — what was never there in the first place — is a reason for anyone to mention them in an eight-minute appointment.
A 1993 federal document on dietary supplements, partly redacted.
June 1993. The notice that started the fight was forty pages of regulatory language. The response to it was measured in mail sacks.
See today’s pricing & availabilityThe five botanicals described in this piece

The appointment lasted eight minutes. Tanya timed it, because she had waited forty for it.

She is 49, works in claims processing in Milwaukee, and had come with a list on her phone: the nights that broke at three, the stretch after lunch when her eyes would not stay open, the feeling — she struggles to name it — of running the same body on less current. The doctor listened. She nodded. She wrote something down.

"It was a synthetic. A hundred and eighty-six dollars a month after insurance," Tanya says. "And I want to be fair to her. She wasn't wrong to offer it. It's what she has in the drawer."

Tanya asked whether there was anything else. Something closer to what her grandmother had used — roots, mostly, boiled in a pot on the back of the stove in Greenville, Mississippi. The doctor gave her the look she says every woman over 45 eventually gets, and the four words that go with it: there isn't enough evidence.

She went home and typed the sentence into her phone. What came back was not a wellness blog. It was a fight from 1993, and it explained the look.

"It's not that they didn't want me to know. It's that nobody was ever paid to tell me."

What "not enough evidence" actually means

Start with the thing nobody says out loud in a waiting room: you cannot patent a root.

You can patent a molecule. You can patent a synthetic version of something a plant makes. You can patent the coating on a pill. But maca has been growing in the Peruvian Andes for a very long time, and ashwagandha in India for longer, and neither belongs to anyone. Which sounds like good news until you follow it one step further.

The kind of trial that would make a doctor comfortable — thousands of women, several years, placebo-controlled — costs more than most plants will ever earn anyone. Nobody funds that trial for a root they cannot own. So the trials that exist are small: forty women, sixty, a hundred, eight weeks, twelve. And small trials, in the language of the appointment, are "not enough evidence."

Then the last step. Nobody sends a representative to the doctor's office to talk about fenugreek. There is no lunch, no sample, no laminated card. The synthetic has all three. So when eight minutes are up, the doctor reaches for the thing that has been put in front of her every week for twenty years, and the plants stay where they have always been: in a grandmother's kitchen, on the shelf of a store the doctor has never walked into.

Why this is not a conspiracy:No one in this story is lying. A doctor who says "not enough evidence" is describing the size of the trials, accurately. The trials are small because no one can own the plant. That is not a plot. It is a spreadsheet — and it produces the same silence a plot would.
I spent twenty-two hundred dollars last year on a prescription that gave me headaches. When I asked about plants, she looked at me like I'd asked about crystals. I didn't ask again.Darlene W. · 52 · Milwaukee WI★★★★★

1993: the year it nearly went away

Here is the part Tanya found on her phone, and the part this piece has checked.

In June 1993, the Food and Drug Administration published what is called an advance notice of proposed rulemaking on dietary supplements. It is a dry document. It asked how vitamins, minerals, amino acids and herbs ought to be regulated, and it raised the possibility that some of them should be treated under the frameworks used for drugs and food additives — frameworks that require proof of safety and effectiveness before a product can be sold.

The agency's view, then and since, was that it was doing its job: products were being sold with claims nobody had checked, and a few had hurt people. Critics read the same document and saw something else. Applied to a root that no company could patent, a pre-market approval standard was not a hurdle. It was a wall. Nobody would pay to get maca over it, so maca would simply be gone from the shelf.

What happened next is the reason the story is still told. Health food stores staged "blackout days," covering their shelves in black cloth to show customers what was at stake. An industry-funded television spot showed the actor Mel Gibson being raided by federal agents over a bottle of vitamin C. And ordinary people — church groups, retirees, women who had been buying the same bottle of something for twenty years — wrote to Congress. The industry's line at the time was that the mail outran any issue since the Vietnam War. Whether that was literally true is hard to verify now. That the mail was enormous is not disputed by anyone.

Five plants laid out on a table like evidence.
The defendants. Roots and seeds that no company could own — which is exactly why no company was going to pay to defend them.

Senator Orrin Hatch of Utah, a Republican, and Senator Tom Harkin of Iowa, a Democrat, sponsored the Dietary Supplement Health and Education Act. In October 1994 it passed both chambers by unanimous consent — no roll call, no recorded no vote — and President Clinton signed it into law on the 25th. Supplements would be regulated as a category of food, not as drugs. The FDA could still act against a product it could show was unsafe, but it would no longer require proof before a bottle went on a shelf.

I'm a church secretary. I showed this to my pastor and he remembered his mother writing one of those letters. Nineteen ninety-four. Nobody told us what it was for.Gloria T. · 49 · Columbus OH★★★★★

What the law did — and what it did not do

It is worth being honest about both sides, because Tanya was.

Critics of the 1994 law have said, for thirty years, that it left the public on its own: a bottle can reach a shelf without anyone outside the company checking what is in it. The industry's view is that the law preserved access to plants people had used for generations, and that a drug-style standard would have taken them away from exactly the people who could least afford the alternative. Both are true. That is the uncomfortable part.

One detail from the law is worth knowing, because you have seen it a thousand times without noticing. The 1994 act allowed a supplement to say what it does for the body's structure or function — "supports," "helps maintain" — as long as the same label carried a sentence saying the FDA had not evaluated the claim. That sentence is the small print at the bottom of this page. It is not a dodge. It is the line that was drawn in 1994 between what a plant may say about itself and what only a drug may say, and it has not moved since.

What the law did not do is change the arithmetic in the first section of this piece. It did not create a reason for anyone to fund a large trial of a root, because the law does not require one. So the plants survived, and the silence around them survived too — not because anyone banned them, but because the incentive to talk about them never existed and still does not.

  • What survived: the right to buy the plant, and the plant itself, with its milligrams printed on a label if the company chooses to print them.
  • What never arrived: the funding, the large trial, the sales representative, the eight minutes. Those still belong to the thing in the drawer.
Said plainly:The government did not hide these plants from women over 45. The market simply never had a reason to bring them up. The result, from the chair on the paper, feels the same.
My mama boiled roots from the yard for everything. I thought it was old-fashioned. Turns out nobody was ever going to tell me otherwise, because nobody was getting paid to.Francine M. · 55 · Baton Rouge LA★★★★★
See what she's been taking →One dropper, before the coffee

What it does — and what it does not

Tanya's list, after two months of reading, came down to five plants. Four are roots or seeds that have been used for a long time in places far from Milwaukee; the fifth is an amino acid. Here is the honest version of each, which is a shorter version than the one the rest of the internet offers.

First, what none of them do. Nothing on this list is a hormone. Nothing on it replaces what a body has stopped making, and nothing on it is a substitute for what the doctor wrote down — if that is what you need, this is not it, and Tanya is careful to say so. Nothing moves, burns, or redistributes anything. There is no weight promise anywhere on this page.

What is on the table is the terrain: the stress that never quite comes down, the nights that break at three, the afternoon current, the circulation. That is a smaller promise than the one made in 1993 by either side. It is also the one that can be kept.

  • Ashwagandha The stress end of it. Several trials report lower cortisol; the evidence is real but early, and the effect sizes are modest.
  • Maca An adaptogen — not a phytoestrogen, whatever other pages tell you. Small trials report better mood and energy through the transition, with no change to hormone levels.
  • Fenugreek Used for comfort through the change. Note it can lower blood sugar and it is a cross-allergen with peanuts and legumes.
  • Beet root and L-arginine Circulation and blood flow. Nitrate to nitric oxide — unglamorous, and honest about what it is.
A small amber bottle with a dropper, beside its box.
The bottle Tanya settled on. Five botanicals, 2 mL, milligrams printed on the back rather than hidden behind the word "blend."
Said plainly:Nothing here is a hormone, nothing here is hormone replacement, and nothing here is a weight-loss product. If a page in this category tells you a root does what the drawer does, close the page.
Fifty-one, raising two grandbabies, working retail. I didn't want a miracle. I wanted to not feel like the day started with a debt. That's the size of what I got.Ernestine P. · 51 · Savannah GA★★★★★

What her grandmother actually did

This is the part Tanya says she got wrong for two months, and the part that matters more than the law.

She had gone looking for the plants. She should have been looking at the pot. Her grandmother did not take anything when she felt bad. She took the same thing every morning, before the first decision of the day — before the stove was lit, before anyone else was up — and she did it for forty years without once calling it a routine.

"I kept reading about the ancient secret," Tanya says. "The secret was that she never missed a morning. There was nothing else to it."

It is, when you look at the small trials honestly, the same thing they show. The women who report better mornings at week eight are the women who took the plant every day for eight weeks. Nobody has ever run a study on taking it when you happen to think of it, because there would be nothing to measure. Tanya's grandmother did not have a study. She had a pot and a habit, and the habit was the part that worked.

That is the thing a small amber bottle with a dropper can actually offer, and it is less than the sales page says and more than the appointment does. One dropper under the tongue, thirty seconds, before the coffee. Not when you remember. Before the coffee, so that remembering is not part of it.

A woman in her fifties on her couch, reading on her phone.
Tanya, the night she found the 1993 notice. "I read it twice. Then I called my sister."
The bottle lives next to the coffee maker. That's the only reason it works. If it lived in the cabinet I'd have forgotten it by March.Carolyn D. · 47 · Little Rock AR★★★★★

Nine months, honestly

Tanya kept notes, because she processes claims for a living and does not trust memory. Here is her timeline, with the disappointing parts left in.

The first two weeks were about whether she remembered. That is all. She missed three mornings in the first ten days and nearly quit on day eleven. Moving the bottle next to the kettle fixed it.

Around week six she noticed that she had not woken at three for a while — not "slept beautifully," just not woken. The stretch after lunch was still there but shorter. "I wouldn't have sworn to it in court," she says. "I'd have said maybe."

At three months her sister said something at a Sunday dinner about her seeming "less braced." That was the first time anyone else noticed anything, and it was the moment Tanya says it stopped being a maybe.

Nine months in, she is still taking it. She is also still, she points out, 49. "It didn't make me 35. It made me a 49 that isn't running on fumes by two o'clock. I'll take that."

Who this is wrong for:If you need week two, this is the wrong bottle and you will be disappointed on day fifteen. If you want something to replace what the doctor offered, this is not that either — talk to her. Individual results vary.
My doctor told me "this is just what happens after 45." I don't think she was lying. I think it was the only sentence she had time for.Bernice J. · 50 · Raleigh NC★★★★★
Read the label for yourself →Milligrams printed on the back, not a blend

What is in the dropper

Five botanicals in 2 mL, with the headline milligrams printed on the back of the bottle rather than hidden behind the words "proprietary blend."

Ashwagandha (Withania somnifera)Ashwagandha (Withania somnifera)The stress end of it. Trials report lower cortisol; evidence real but early.
Maca root (Lepidium meyenii)Maca root (Lepidium meyenii)An adaptogen, not a phytoestrogen. Small trials report better mood and energy, with hormone levels unchanged.
Fenugreek (Trigonella foenum-graecum)Fenugreek (Trigonella foenum-graecum)Used for comfort through the change. Can lower blood sugar; cross-allergen with peanuts and legumes.
Beet root (Beta vulgaris)Beet root (Beta vulgaris)Circulation. Nitrate to nitric oxide — an established pathway.
L-arginineL-arginineA nitric oxide precursor, included as a co-factor alongside the beet root.
Liquid under the tongue rather than a capsule. Not a hormone, not hormone replacement, not a weight-loss product.

The drops Tanya refers to in this piece

Tanya does not name a brand in the body of this article. For readers who have written in asking: it is ADIRA DailyDrop™ — the five botanicals described above, with the headline milligrams printed on the label.
See the label and current pricing →Opens the product page
Returns are handled by the brand — 90 days, opened bottles included.
The Midlife Review may earn a commission on purchases made through links in this article. Nothing in this piece was reviewed or approved by the brand before publication. Speak to whoever prescribes your medication before adding any supplement, particularly if you take anything for blood sugar or thyroid, or if you are pregnant or nursing.

Before you order

Is this going to make me lose weight?
No. There is no weight-loss claim on this page and you should be suspicious of any page in this category that makes one.
Is it a hormone, or a replacement for what my doctor offered?
No. No hormones, not hormone replacement therapy, not a substitute for it. If your doctor has prescribed something, that is a conversation to have with her, not with a bottle.
Can I take it with my medication?
Ask whoever prescribes it. Fenugreek can lower blood sugar, which is a real consideration if you take metformin or anything else for diabetes. Same conversation for thyroid medication, and if you are pregnant or nursing.
Did the government really try to ban these plants?
The 1993 FDA notice is real and public, and critics at the time said it would have had that effect on herbs. The agency's own position was that it was proposing safety standards, not a ban. The 1994 law that followed is also real, and passed by unanimous consent. We have tried to present both sides as they were argued.
What if it does nothing for me?
90 days, money back, opened bottles included. Returns are handled by the brand.

What readers have written in

Lightly trimmed for length, names shortened.

★★★★★
Six months. I stopped waking at three around week seven. Nothing dramatic before that, which is exactly what the article said.
Renata S.48 · Park Forest IL
Verified
★★★★★
The doctor part is word for word what happened to me in Memphis. Eight minutes, a prescription, and the look.
Carla D.53 · Memphis TN
Verified
★★★★★
I keep it next to the coffee maker like she said. That's the whole trick. Four months in and I'm not bracing for two o'clock anymore.
Stephanie R.45 · Brooklyn NY
Verified
★★★★★
My mother wrote one of those letters in 1993. I found out reading this. Ordered the same night.
Linda M.57 · Baltimore MD
Verified
Reader comments on this article
213 commentsMost relevant ▾
Rochelle Mimsshowed my pharmacist this and even SHE didn't know about the 1993 thing. that tells you everything
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Carolyn ReevesTo be fair to her — it was thirty years ago and nobody teaches it. That was rather the point of the piece. — CR
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Tisha Lawsonsent this to my sister and my two aunts. we all started the same week. six weeks in and Aunt Pat says she's not waking up at 3 anymore. not emotional about supplements but I'm emotional about that
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Vanessa Hollisappreciate that this one actually says what it DOESN'T do. every other page in this category promises the moon
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Jackie WinfieldI work nights at a hospital. "not enough evidence" is what we say when nobody paid for the study. she's right about that part
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Carolyn ReevesJackie, if you read the P.S. you'll meet a night-shift nurse who'd agree with you. — CR
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Denise Carringtonmy mama boiled roots too. Greenville. reading this on my couch and I had to put the phone down for a minute
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P.S. Tanya's neighbor Gail is 53 and has worked the night shift at a Milwaukee hospital for nineteen years. She started the drops in the spring, mostly to stop Tanya talking about them. Two months later she texted her from the parking lot at 7:40 in the morning, at the end of a twelve-hour shift: "Tanya, I forgot to be tired today." Tanya has the screenshot. She says it is the only review she needs.
See the label and current pricing →Opens the product page
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Individual results vary. Consult your physician before use if you are pregnant, nursing, or taking prescription medication.
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