By James J. Gormley
DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law which protects our access to dietary supplements and to truthful information about them; it also provides for the quality and safety of supplements.
What led to the passage of this law was a historic grassroots and political battle, a struggle that actually had its roots in the early days of the modern health-food industry.
In 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA). This legislation was intended to improve nutritional information regarding health claims made for products. The FDA was given the job of implementing the law, but because of its broad wording, the agency began to capitalize on the opportunity to over-regulate safe and beneficial nutritional products.
In 1992, the Health Freedom Act was introduced in the Senate by Sen. Orrin Hatch, along with a similar bill in the House of Representatives, to protect the rights of U.S. citizens to choose safe and effective dietary supplements.
“The basic principle of the Health Freedom Act […] was that supplements aren’t food additives, they aren’t drugs and they need to be defined,” said Loren Israelsen, head of the LDI Group and the United Natural Products Alliance in Salt Lake City in a 2004 interview with Mitchell Clute in Natural Foods Merchandiser (NFM) that ran as a “10 years after DSHEA” anniversary article.
In an April 27th 2009 interview, Israelsen told The Gormley Files that “FDA began using the food additive provisions of the law as a tool to go after dietary supplements FDA did not like. This misuse of the law really ticked off a lot of people (me included).”
“The FDA Commissioner at that time, David Kessler, had commissioned a panel to study the question, ‘What should we do with supplements if we were to start afresh?”, noted Israelsen.
“Initially, FDA refused to make the report public. Ultimately, under pressure they did, and it confirmed our worst fears. Those are a few examples of the long fuse that burned up to 1992 when the first version of DSHEA called ‘The Health Freedom Act’ was introduced.”
The agency took the position that all supplements that did not have what it considered defined nutritional value were unapproved food additives. In this way, said industry attorney Marc Ullman, the FDA was able to keep many herbal supplements from American consumers. The FDA essentially went on an enforcement rampage.
The case that mobilized consumer opinion most against FDA was the Jonathan Wright case. Wright, a physician in Washington state, continued to prescribe L-tryptophan to his patients, knowing that while the U.S. had temporarily issued a ban on its sale as a dietary supplement, it had not explicitly banned its use for medical purposes.
On May 6th 1992, in what is today remembered as the Tahoma Clinic Raid, the FDA stormed Wright’s clinic with armed sheriffs who terrorized patients and seized vitamins, equipment and medical records. “The raid made no sense,” noted Israelsen. “There was no rational explanation. People began to think, ‘Wow, what are they prepared to do to stop us from taking vitamins.’ “
And this legitimate fear began to spread like wildfire across the country.
On the grassroots side, Joe Bassett and the northwest region of the Natural Products Association (or NPA, then NNFA) expanded an early incarnation of Citizens for Health (CFH) in order to mobilize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and others.
The American Botanical Council and the American Herbal Products Association (AHPA) were also important forces from the industry side.
Meanwhile, a dramatic public-service ad (PSA) was developed. In the ad, federal agents equipped in full Special Forces gear, including night vision and weapons, converge on Mel Gibson, in this now-famous cameo, who says, in defense as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”
This call-to-action video (which was produced by noted Los Angeles-based producer/director, Back Home Pictures' Charles Abehsera and funded by an industry task force that included Patrick Mooney of California.-based Super Nutrition) warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”
Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?” While the video was a dramatization to be sure, it visualized a nightmarish scenario that was truly only one step away from reality at that time.
Another dramatic, and effective tactic used to educate consumers about the threats posed by the FDA’s efforts was the blackout day that was held.
Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store before DHSEA was passed.
“I vividly recall our putting on a ‘black out’ day. We got black mesh fabric and covered every product that would not be available for sale if DSHEA did not pass. It was nearly our entire supplement section! Products were available for sale but our staff was telling people why we had this restrictive covering […] and signage […] as well. Tables and chairs were set up for any customers who wanted to write a letter to Congress telling them how important access to dietary supplements was to them.”
Meanwhile, industry champions such as Loren Israelsen, Scott Bass (son of the late Milton Bass), Hal Drexler (of Country Life), Jarrow Rogovin (of Jarrow Formulas) and many others, were devoting considerable resources to the battle for DSHEA up to (and past) the 11th hour.
Although the Democrats had a majority in the House and Senate, indicators were that the party was in danger of losing a number of seats in the 1994 election and the Democratic leadership was not eager to look like bad guys to the millions of Americans who supported the Hatch-Harkin-Richardson Bill (DSHEA).
“Then a miracle happened,” Israelsen told NFM. Over the course of several hours, Senators Hatch, Kennedy, Harkin, Waxman and Congressman Dingell were able to hammer out a compromise bill.
“The bill never went through committee and was never voted on, contrary to popular myth,” said Israelsen in NFM. “It went from a zero, a nothing in the House to being a bill flying through by unanimous consent in the middle of the night. I think the FDA thought this bill would never pass and when it did they couldn’t believe it.”
“DSHEA was crafted in a very specific way to keep supplements within the confines of current food law and statutory interpretation,” Israelsen told The Gormley Files.
“There were a number of reasons this was done. We could have opted to make dietary supplements a separate category from foods and drugs. However, this would have left us with essentially no ‘software or hardware’ to deal with lots of issues for which we needed some framework and existing law.”
Although the story of how DSHEA was truly won is sometimes not told accurately, however, “Those who made a difference know what contributions they made,” noted Alex Schauss.
“They will always find satisfaction in having made a difference that influenced the course of history. Everyone made a difference. That’s the real story that hasn’t been told.”
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