Why the FDA Does Not Approve Supplements

David A Kessler, M.D, J.D.
November 20, 1999

This article is a slightly condensed version of a talk given at the Good Housekeeping Institute Consumer Safety Symposium on Dietary Supplements and Herbal Remedies, held in New York City on March 3, 1998. Dr. Kessler was FDA Commissioner from 1990 through 1997 and currently is dean of Yale University School of Medicine.

The Food and Drug Act, passed in 1906 and 1938 and amended many times, generally divided the array of consumer products that fell under the FDA into a number of different categories. There were foods; and there were drugs. Drugs, beginning in 1962, required approval. Before you can go on the market and sell a drug, you’ve got to come into the FDA and submit evidence. You have to submit an application. Foods never required preapproval. Food additives, things that would go into food, did require preapproval.

Where do dietary supplements fall, and where did they fall? And the answer to that was it depends. Many times dietary supplements were viewed as simply as foods. But the agency said if they made claims — health claims, disease claims — then they would be regulated as drugs. In the 1980s, foods, many different food manufacturers, started making health claims. You could sell a food or market a food on the basis of the fact that it was good for you — today we take that for granted — but back in the early 1980s, that was something that was new. And food companies wanted to start making health claims. So that raised the question and again blurred the line between what’s a food and what’s a drug and then the hard question, again, where do dietary supplements fit in?

Along comes the debate on food labeling. Food companies making an increasing number of health claims, supermarkets filled with all those health claims, the public asking the FDA and the Congress to help sort out what was true and what was not true. You heard debate on what today is referred to as the Nutrition Labeling Education Act. It was 1990. In that act, Congress said that foods could make health claims but they had to be in essence approved by the FDA.

What about dietary supplements? Well, Congress couldn’t in 1990 reach a conclusion on that. Senator Hatch said, “I don’t want the same standard for foods, for dietary supplements. Dietary supplements shouldn’t have to go through preapproval.” Other senators argued for preapproval on those health claims. Congress couldn’t agree. So what did it do? In 1990, it said in the Nutrition Labeling Education Act, FDA you go decide whether foods and dietary supplements should have the same standard. Should they be required to both have a preapproval of those health claims or should dietary supplements be treated differently? That’s where the controversy began and that’s where — that’s where the real debate started.

FDA answered that question. It looked at the question and said that foods and dietary supplements should be treated similarly. If they want to go make health claims, there shouldn’t be a different standard; and FDA should approve those health claims.

How the Law Was Weakened

That conclusion — that no health claim should be on dietary supplements, no health claim should be on food unless the agency reviewed the evidence — set off one of the most intense lobbying campaigns that I certainly have ever witnessed. I still remember it to this day. I remember having to answer questions about why is FDA going to require prescriptions for vitamins? I remember the ad with Mel Gibson with FDA agents breaking into someone’s home to take away his vitamins. It was a brilliant lobbying effort. It also was a lie.

Whether people were just prophetic, whether they were able to predict and knew where they wanted to get to today, I can’t answer. But it all started back in the early 1990s. Congress got enormous mail — mad that FDA was taking away everyone’s vitamins, that FDA was going to require prescriptions. But that wasn’t what FDA was saying. What FDA was saying was if you’re going to make claims, you had to have the evidence, the agency had to review that evidence before those claims were made. Tons of mail; and yes, there were advocates of the Dietary Supplement Act, and yes, it did pass unanimously. For the average member in Congress, there was such mail, the lobbying was so intense, that I think the view for most members was, just get this off my plate.

And how did they get it off their plates? They passed the Dietary Supplement Health and Education Act of 1994. It’s generally known in the trade as DSHEA. Some viewed it as a compromise. Some viewed it as caving in. Some viewed it as the right policy. . . . DSHEA says that dietary supplements should not make health claims without evidence, without FDA approval. Dietary supplements should not make disease or health claims. However . . . . they can make claims that supplements affect the structure or function of the body.

I remember sitting there. I remember talking to Hill staff at the time. I said, well, what about a claim that says, improves memory? Is that a disease claim, is that a health claim, or is that a structure or function claim? You could predict — and many did argue, back in 1994 — what would happen. If you open up the opportunity to make structure or function claims. . . what would you predict would happen? And in the end, the question becomes, “Is the consumer better off today in 1998 after DSHEA than before DSHEA?

Lack of Ethics

I went into my chain drugstore the other night and I walked back to the pharmacy counter. And certainly we could all do that, and you could also see what a number of you are reporting, the explosion, the exponential growth in dietary supplement sales. And you could see it in the drugstore. There next to the pharmacy counter — not just in any of the aisles, but right there underneath the pharmacist, next to the pharmacist, I counted 26 different displays for dietary supplements making claims. Let me read to you what I just saw as I was looking at the different products:

  • “Targeted mind improvement”
  • “Improves memory and concentration”
  • “Advanced memory and concentration formula”
  • “Memory support complex”
  • “Helps increase serotonin level.” Serotonin (for the more sophisticated consumer) is a mood enhancer
  • “Immune enhancer”
  • “May help reduce cholesterol”
  • Claims for leg health . . . What’s leg health? Who worries about their legs?
  • Claims for cartilage rejuvenation and repair.

And then there was the best claim that I saw. You’ve got to love the entrepreneurship, the creativity. There on the panel, the front panel it says, in small type “As featured in the book The Arthritis Cure.” I think by anyone’s standard — walking into that drugstore — I think certainly with any scientific standards, one has to conclude that [the situation] is out of control today.

I was talking to someone in the industry recently. I asked, “How do you decide what goes on the label? How do you decide what claims to make? Over-the-counter drugs, that labeling has to be approved in the application. How do you decide?”

The answer was striking. I’m sure it’s not true for many companies, but I found the answer rather interesting: “You know how we decide what to put on the label? We do focus groups.”

I then asked:

These things are being sold — not in just specialty stores, these are being sold in chain drugstores. Where is the oversight? Don’t these pharmacists look and see what you’re selling? . . . For the last fifty years “effectiveness” meant something very important in food and drug parlance. Effectiveness meant — at least to me — that there’d be the scientific evidence to demonstrate that something worked.

The person said to me: “Effectiveness is measured whenever something moves off the shelves.”

I’m concerned less — to be honest with you — about the manufacturer. The real disappointment is what I’ve seen just as a professional, as a dean of a medical school, I wonder whether many pharmacists really have given up their roles as health professionals. . . . Maybe they’re no longer in control of the store. Maybe they’re just behind the counter, and anything in front of that counter goes. But it’s time for that profession to take responsibility for what it’s selling.

The Regulatory Dilemma

Where are we headed? DSHEA called for a presidential commission. And one of the purposes of that presidential commission was to answer a basic question: “Should there be one standard for both food and drug when it comes to, disease claims?” The agency answered that back in 1990 and said yes. And that set off a fire storm. The presidential commission, as I read it, also answered yes. But that no longer is the question, because there is that other provision, the “structure-function” loophole. The presidential commission got it 100% right. “Representatives of the dietary supplement industry.” they said, “It is time for the FDA to give guidance on the structure or function claims and where does that structure or function claim cross the line.

The FDA has — under that statute — ninety days to act. And that ninety days tolled last week. If I had surmised — just knowing what I know about how the agency works and thinks — I would guess that the agency will do exactly what the presidential commission asked it to do, and that is to help define where that line is between structure and function claims and disease claims. It’s a hard question, but the agency can tackle it. And I’m sure if you ask a group of people today where that line is, you’ll get as many different answers as there respondents. But I believe that is an essential task; and I believe we do need to come together on a consensus, as difficult as that question is.

If I say to you, “put a claim on a label that says mood enhancer,” is that a structure or function claim? Is that a health claim? Where do you put it on the spectrum? I would argue that it’s not important what I think or what you think. I think what’s important is what the consumer thinks. And I think when you look at that question, I think it depends where the consumer sits. If you are a consumer who suffers depression and you see something on the label that says mood enhancer, that’s a health point. If you’re healthy and you see — and you had a rough day, then it’s not a disease claim. It depends where you come from. It depends what your perspective is. One thing about food and drug law is clear: it is not only what you say on the label, it is also what implications you create. And if the claim in the eyes of people who have diseases are that that claim will help me, will help me in dealing with my disease, I think in the end, that’s that test. . . .

I applaud Good Housekeeping for doing what it always does best, for standing up for informing the public. I think certainly there aren’t a lot of people doing it these days, especially when it comes to dietary supplements.

How DSHEA Weakened the FDA

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This article was posted on November 20, 1999.