The History & Future of the Dietary Supplement Health & Education Act

[Guest guest]

Will dietary supplements remain available? This leading law firm explains

how we got to where we are under DSHEA. This history is astounding to learn

that Dr David Kessler was apparently outraged over DSHEA and felt if he, as

head of FDA, told them to ignore the dietary supplement industry,

believing that so much harm would soon occur that congress would have to

rescind

DSHEA.

 

This report ends on a positive note:

 

The policies and programs the new leadership in FDA is likely to adopt

under DSHEA cannot be predicted. But because DSHEA is a very sound statute

that balances industry flexibility with strong enforcement power lodged in

FDA, the dietary supplement industry should have little to fear in the future.

 

Of course, there are many other obstacles facing the industry such as

CODEX but this at least sounds encouraging.

 

Garry F. Gordon MD,DO,MD(H)

President, Gordon Research Institute

www.gordonresearch.com

 

The History & Future of the Dietary Supplement Health & Education Act

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Copyright 2009 by Virgo Publishing.

http://www.naturalproductsinsider.com/

By:

Posted on: 09/21/2009

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by Peter Barton Hutt

We celebrate this year the 15th anniversary of the enactment of the Dietary

Supplement Health and Education Act of 1994 (DSHEA). But landmark

legislation like DSHEA does not spring full blown from the fertile imagination

of

members of Congress, nor does the enactment of such legislation follow a

preordained result. The history that led to the enactment of the statute, and

its subsequent implementation, are therefore worthy of full consideration.

Legislative History

The earliest dietary supplements marketed as such in the United States

were cod liver oil products promoted in the 1920s for their vitamin A and D

content. FDA soon discovered some were providing less of the promised vitamins

than the label stated. FDA began a series of seizure actions in the courts

that lasted a full decade. In part, this regulatory response was fueled by

the conclusion of many in FDA that dietary supplements are unnecessary for

any person who eats properly—a feeling that has continued to persist

within the agency up to this very day.

When the Food and Drugs Act of 1906 was replaced with the Federal Food,

Drug and Cosmetic Act of 1938 (FD & C Act), Congress included Section 403(j) to

authorize regulations governing the labeling of food “for special dietary

uses.†FDA promptly exercised this authority to require the labeling of

both fortified food and dietary supplements. As dietary supplements expanded,

however, and their claims became more aggressive, FDA reverted to the

enforcement approach used in the 1920s. During the 1950s, FDA, with the

assistance of FTC, launched the most intensive enforcement campaign in agency

history. FDA brought hundreds of seizures, injunctions and criminal actions in

the courts against what the agency concluded were misbranded dietary

supplements.

When this failed to slow the steady expansion of the dietary supplement

industry, FDA abandoned court enforcement and proposed new regulations

designed to limit both the specific nutrients and their levels in dietary

supplements. These regulations became the subject of the infamous evidentiary

trial-type hearing before an Administrative Law Judge in 1968 and 1969, where

FDA and the industry proffered testimony of 162 witnesses and introduced

into evidence more than 2,000 documents.

FDA pushed ahead following those hearings, publishing final regulations in

1972 that mirrored the 1962 proposal. But in 1974, the U.S. Court of

Appeals for the Second Circuit overruled parts of the regulations and stayed

the

remainder. Sen. William Proxmire (D-Wis.) spearheaded enactment of the

Vitamin-Mineral Amendments of 1976, which further reduced FDA flexibility in

regulating dietary supplements. Recognizing momentum had been lost, in 1979

FDA revoked all of the regulations it had promulgated in 1972, including

those that had been upheld in the courts.

The Nutrition Labeling and Education Act of 1990

In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA),

which gave FDA authority to approve disease prevention claims for all

food, including dietary supplements. From the beginning, FDA Commissioner David

Kessler, M.D., saw this as a way to win back the ground FDA had previously

lost to the dietary supplement industry. Rejecting advice to be cautious

on this matter, he announced in 1993 that FDA would not approve any proposed

disease prevention claims for dietary supplements, even when they were

approved for conventional food, and would attack dietary ingredients other

than essential vitamins and minerals on the ground that they are illegal food

additives and therefore must be removed from the market. It was one of the

worst decisions by an FDA commissioner in the agency’s entire history.

DSHEA: The Kessler Act

The dietary supplement industry mobilized a grassroots campaign that is

widely regarded as one of the most successful political movements in American

history. Every health food store in the country campaigned for

congressional action to stop FDA from carrying out Kessler’s policy. Outraged

citizens

showed up at speeches made by candidates seeking votes in the

congressional election of 1994, when the Republicans eventually gained control

of the

House and Senate for the first time in more than 40 years, and harangued the

candidates about FDA taking away their freedom to consume dietary

supplements. Just weeks before the election, recognizing that dietary

supplements

were becoming one of the largest issues in the campaign, Rep. Henry Waxman

(D-Calif.)—the strongest opponent in Congress of the dietary supplement

industry—informed the industry he was prepared to negotiate a dietary

supplement law. The industry had been drafting a bill, but few expected that it

could be passed. The Council for Responsible Nutrition (CRN) was so surprised

at Waxman’s capitulation that at first it did not believe it was true. But a

final bill was quickly put together and enacted in October 1994, just

before the election.

In retrospect, the entire dietary supplement industry owes its current

stature and economic strength to David Kessler. Without him, DSHEA would never

have been enacted. It was his arrogance and political insensitivity that

allowed the champions of dietary supplements to carry their message to the

American public, and it was the American public that rejected Kessler’s

attempt to ban dietary supplements. I have often remarked that the dietary

supplement industry should erect a monument to David Kessler in commemoration

of his tremendous service to the industry.

Implementation of DSHEA

DSHEA did not give dietary supplements a free pass to the marketplace. In

fact, I have published a detailed analysis of DSHEA that concludes the law

provides FDA with ample legal authority to prohibit all unsafe or mislabeled

dietary supplements in the marketplace. In some respects, its enforcement

provisions are stronger than those applicable to other food categories.

Kessler was so infuriated by the enactment of DSHEA, however, that he

ordered FDA not to enforce the new law. Initially, this was not widely

understood. As time has gone on, however, former FDA enforcement officials have

admitted that, for the first full decade under DSHEA, FDA took virtually no

enforcement action because of Kessler’s policy. Kessler was convinced if the

law was not enforced and the worst elements of the dietary supplement

industry were allowed to run wild, Congress would repeal the law. Of course,

that

did not occur. For a full decade, however, Kessler sacrificed protection

of the public health to his own personal animosity toward DSHEA.

When Mark McClellan, M.D., became FDA commissioner in November 2002, he

put an end to this absurd policy and began to enforce DSHEA to the same

extent that any other provision of the FD & C Act is enforced. For the next five

years, however, enforcement of DSHEA was hampered by the lack of adequate

congressional appropriations. For example, it took more than a decade for FDA

to promulgate the GMP (good manufacturing practice) regulations that were

authorized under DSHEA. Even when the policy against enforcement of DSHEA

was lifted, sufficient funds were only available to support a limited number

of warning letters against dietary supplement claims. CRN was forced to

step into the void to fund a special program for review of dietary

supplement claims under the National Advertising Division (NAD) of the Better

Business Bureau.

Kessler’s adamant refusal to consider disease prevention claims for

dietary supplements inevitably clashed with the First Amendment to the U.S.

Constitution. In the landmark case of Pearson v. Shalala, the U.S. Court of

Appeals for the District of Columbia held in 1999 that FDA could not

constitutionally ban dietary supplement claims supported by credible scientific

evidence. Although FDA persisted in attempting to get around that decision, it

has lost case after case in the courts. FDA has been forced to recognize

so-called “qualified†disease prevention claims as well as the statutorily

established “significant scientific agreement†claims. The agency has

repeatedly stated the qualified claims are permitted under its “enforcement

discretion.†This is, of course, nonsense. They are permitted because the

Constitution requires it.

For the most part, FDA has done a reasonable job in distinguishing between

permissible structure/function claims for dietary supplements and

impermissible disease claims. The 50-page preamble to the January 2000 FDA

regulations defining the difference between a permitted structure/function

claim

and an illegal disease claim establishes guidelines that are workable, even

if large parts are unintelligible. FDA has not sought to erect barriers to

reasonable structure/function claims for dietary supplements.

Although it took a long time for FDA to act, the agency showed DSHEA is

adequate to protect the public from unsafe dietary supplements when it

removed ephedra from the market as an “unreasonable risk.†This decision has

properly been upheld in the courts.

The Future of DSHEA

By now, it should be clear, with proper enforcement, unsafe or mislabeled

dietary supplement products can readily be removed from the market by FDA,

leaving safe and properly labeled products for the consuming public. And

for the first time in years, FDA now has sufficient appropriations for proper

enforcement of DSHEA. In the fall of 2007, FDA Science Board issued a

report documenting the increased responsibilities and reduced appropriations

available to the agency. The House Oversight and Investigations Subcommittee

held a bipartisan hearing in January 2008 documenting the devastating

impact this has had on the entire agency. As a result, FDA appropriations have

increased from $1.4 billion to $2.3 billion, a large part of which has been

allocated to the Center for Food Safety and Applied Nutrition (CFSAN),

where dietary supplements are regulated.

With the election of President Obama, an entire new leadership has been

installed in FDA. Both the new commissioner, Margaret (Peggy) Hamburg, M.D.,

and the new deputy commissioner, Joshua Sharfstein, M.D., have led large

complex scientific organizations (the New York City Department of Health and

the Baltimore Department of Health, respectively) and bring an entirely new

public health perspective to FDA. With the increased appropriations, they

have the funds to implement DSHEA more effectively than at any time in the

past 15 years.

Commissioner Hamburg announced a major priority will be enforcement of the

FD & C Act, including DSHEA. She has outlined a program of increased warning

letters and seizure actions against significant violations. As some of her

first actions, she has singled out dietary supplement products that contain

active pharmaceutical ingredients or that act like illegal steroid

products. This is a good sign for the dietary supplement industry, which has

argued for 15 years that adequate enforcement is essential for the proper

implementation of DSHEA—renegade companies and products harm the entire

industry.

The policies and programs the new leadership in FDA is likely to adopt

under DSHEA cannot be predicted. But because DSHEA is a very sound statute

that balances industry flexibility with strong enforcement power lodged in

FDA, the dietary supplement industry should have little to fear in the future.

 

Peter Barton Hutt is a senior counsel with the Washington, D.C., law firm

of Covington & Burling LLP. Hutt served as chief counsel for FDA from 1971

to 1975. He participated, along with many others, in the drafting of DSHEA

in 1994 on behalf of the Council for Responsible Nutrition (CRN), and has

served as outside counsel to CRN for many years.

 

 

 

 

 

 

 

[Guest guest]

Hi Garry. Thank you for this.

I'm new to this group (and am trying to check out recent posts) so sorry if this

is old ground, but I recommend checking out (and supporting) the 'Alliance for

Natural Health' at:-

http://www.anhcampaign.org/

They have been making quite big waves in Europe in the fight to preserve our

right to natural healthcare for several years now.

 

It's inspiring stuff.

 

All the best,

Derek Haines.

 

, Angls4Hope wrote:

>

>

> Will dietary supplements remain available? This leading law firm explains

> how we got to where we are under DSHEA. This history is astounding to learn

> that Dr David Kessler was apparently outraged over DSHEA and felt if he, as

> head of FDA, told them to ignore the dietary supplement industry,

> believing that so much harm would soon occur that congress would have to

rescind

> DSHEA.

---SNIP---