Showing posts with label Proxmire. Show all posts
Showing posts with label Proxmire. Show all posts

Monday, May 28, 2012

Do Democrats Hate Supplements?

By James J. Gormley

I thought that would get your attention.

Of course the answer is not (categorically) yes.

There are staunch and stalwart dietary supplement champions on the “D” side of the aisle, such as Sen. Tom Harkin (D-Iowa), and one of the greatest supplement industry gladiators of all time, Democratic Sen. William Proxmire (Wisconsin), whose name is attached to one of the most important pro-supplement bills ever passed in the last 100 years, what is often referred to as the Proxmire Vitamin Bill of 1975, or Senate Bill 548, which was signed into law in 1976.

As we approach the November 2012 elections, we may well wonder if one party or another is a better champion of dietary supplements. Some political observers have suggested that the Democratic party may boast a few more anti-supplement foes in Congress than does the Republican party. But do party labels matter when it comes to dietary supplements?

What the Experts in Washington Tell Us
Edward Long, Ph.D., vice president of  Washington, D.C. lobbying firm, Van Scoyoc Associates Inc., told "The Gormley Files" in 2008 that there is no one completely pro-supplement and pro-health freedom party, and that different ideologies run through both major parties.

“There are two strains of Democrats,” noted Long. “One is a populist strain, which goes back to the 1890s, the goo-goos, the good government people who believe that American citizens need to be protected by government in every possible way and to be told what to do. It’s from this camp that a few of dietary supplements’ greatest critics have emerged.”

“Then there’s the more liberal, anarchistic side of the Democratic Party that goes back to the 1960s and 1970s, which holds that mainstream medicine doesn’t really work. It’s out of this strain that we have found a few of dietary supplements’ greatest advocates.”

What about the Republicans? Long said that while there is a sizeable subset of the Republican Party that is opposed to regulation, and over-regulation, in general, “there’s another strain that believes that, in certain cases, we need more regulation.”

Red States, Blue States and Purple States?
Unfortunately, however, goo-goos from the Democratic Party have been consistently proposing, co-sponsoring and advocating for the worst anti-supplement pieces of legislation since the bi-partisan passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

In May 2012, the latest challenge to dietary supplements was Sen. Durbin’s Senate Amendment 2127 that was defeated by a vote of 77 to 20.

Assuming blue states lean Democratic, red states lean Republican, and purple states are up-for-grabs, 13 out of the 20 Senators (or 65%) who voted in favor of Durbin’s amendment (or more technically, voted for it to stay attached to Senate Bill 3187) were from blue states, four were from purple states (20%) and three were Democrats from red states (15%). Here was how the voting went.

Looking back to last year, Sen. Leahy’s Food Safety and Accountability Act, S. 216 (originally introduced as S. 3767), which could potentially criminalize nearly anything related to food and food supplements that the FDA wants, was a fully Democrat-sponsored bill that passed the Senate last April. Looking at this year, it has now moved on to the House.

Also, Democrats have received (and continue to receive) a great deal of criticism from constituents and stakeholders for their weak (or non-) response to the FDA's outrageous NDI Draft Guidance that was proposed last year.

Of course not all anti-supplement legislation originates on the “donkey” side of the aisle. In 2010, Sen. John McCain (R-AZ) introduced the widely vilified Dietary Supplement Safety Act of 2010, or S. 3002, which the Senator was forced to withdraw after massive grassroots opposition.

Of the two much-despised House bills from 2009 (Rosa DeLauro’s HR 875 and Jim Costa’s HR 1332), the former was a 100% Democrat-sponsored bill (with 41 co-sponsors) and the latter was largely (approximately 66%) backed by Democrats.

And for clarity’s sake, it is important to remember that although almost all (if not all) anti-supplement bills are couched in names that carry the word “safety” in their titles, they do not advance safety at all but, instead, reduce consumer access to high-quality, innovative supplements; they are, therefore, anti-safety bills or, at a minimum, anti-health!

Gormley Take-Away: The point of this commentary is not to point any fingers at any one party, as all American patriots are presumably both democratic and republican (lower-case intentional). It is merely to recommend that you do your homework before the November presidential and Congressional elections so that you know which candidates seem most likely to be supportive of health freedom and supplements . . . and which do not. You may also be able to educate your U.S. legislator on the issues if he or she is not familiar with the science, benefits and safety of nutritional supplements. Ask your legislator to join the Congressional Dietary Supplement Caucus, which is currently co-chaired by 2 Democratic Congressmen (Frank Pallone and Jared Polis) and 2 Republican Congressmen (Dan Burton and Jason Chaffetz); Sens. Orrin Hatch (R) and Tom Harkin (D) have previously served as co-chairs. Your U.S. legislators can reach the Caucus at 202-225-2161 (Cannon House Office Bldg., Room 501).

Tuesday, January 27, 2009

What if there were no law protecting our supplements?

A public-service ad that first aired in December 1993 showed camouflaged Federal agents equipped in full Special Forces gear, including night vision and weapons converging on Mel Gibson, who says, in defense, as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

Before DSHEA
This call-to-action video (which was produced by noted Los Angeles-based producer/director, Charles Abehsera) 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 dystopian U.S. society that was truly only one step away from reality at that time.

This ad, together with many other coordinated grassroots efforts, created a groundswell of support for what would become the Dietary Supplement Health and Education Act of 1994, or DSHEA, the law that today protects our access to dietary supplements and to information about these products.

In the 1990s, however, the marketplace and the regulatory landscapes were quite different from today’s. In some ways, the enforcement climate had reverted to that of the days before the Proxmire Vitamin Bill (The Food Supplement Amendment of 1973).

The FDA: an agency on the warpath
Raids, perhaps not as dramatic as the one with Mel Gibson but scary nonetheless, were not uncommon occurrences before DSHEA.

“Although FDA [the U.S. Food and Drug Administration] had been carrying out raids against health-food stores and alternative medicine clinics around the country to harass the supplement industry, when the Health Freedom Act of 1992 was introduced---which became DSHEA---ethical supplement companies knew that there was an uneven playing field on which unethical companies were selling products that did not meet label claims for content or purity and who were making untruthful and misleading health claims for their products,” said Alex Schauss, Ph.D., managing director of AIBMR Life Sciences.

In the 1990s, Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store. He described the countrywide “black out” day this way: “I bill crawford 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.”

How, then, did we go from our victory in the mid-1970s with the Vitamin Bill to the anti-supplement climate of the 1990s?

Annette Dickinson, Ph.D., a noted supplement industry expert, told it to me this way: “In the early 1990s, FDA, under then-commissioner David Kessler, was on a path toward restricting the availability of dietary supplements.
annette dickinson
“In 1993, FDA published a [notice] outlining concepts put forward by the famous ‘Dykstra committee’ suggesting that limits should be placed on vitamins and minerals (perhaps at a few multiples of the RDA), that amino acids were unapproved food additives when used in supplements, and that botanicals […] were inherently […] drug-like and possibly unsafe.”

Mark Blumenthal, the head of the American Botanical Council
agreed: “The Dykstra Report was one of the primary motivators for industry groups that [propelled] industry […] to propose and support Sen. Orrin Hatch’s Health Freedom Act in 1992 which, the next year, was revised and introduced into the Senate as DSHEA.”

Health-freedom advocate and commentator, Elissa Meininger, said that, “Among the events that led up to the passage of DSHEA was the publication of the
FDA’s Task Force Report on Dietary Supplements. In it, there was a statement that I saw as a smoking gun. It stated that the presence of dietary supplements on the market represented a ‘disincentive’ (the FDA’s word) for patented drug research.”

A world without DSHEA
“Without DSHEA,” said Scott Tips, attorney and National Health Scott_Tips Federation counsel, “there would be far more single-ingredient supplements at lower potencies, less innovation and the FDA would be able to squeeze far more than it can now any ‘non-compliant’ companies with fines and compliance actions. The thousands of new products that have hit the supplement market since […] DSHEA would have been a trickle instead.”

In many ways, our country would be similar to Europe minus the natural medicine tradition. I have heard from a number of health-freedom advocates across the Atlantic who have to shop in pharmacies for their supplements, supplements for which they often require prescriptions. High-potency (read: American) supplements are hidden behind the counter and are sold to people only upon request, and on the “QT” at that. Sounds like a black market, doesn’t it?


“Because the American people will not be swayed from their supplements, it is likely that a black market of supplements would have [arisen],” observed Beth Clay, senior vice president at Capitol Strategy Consultants. That’s what it would be like here, in the U.S., without DSHEA. But this black market would come at a price – without the controls such as Good Manufacturing Practices, FDA guidance on labeling and structure function claims, FTC guidance on truth in advertising, and Adverse Event reporting procedures. This would make for a return to the “snake oil” days of the early part of the century.

Now we have had a glimpse of what our country, and our dietary supplement choices, would look like without DSHEA. In what ways is DSHEA better?

“I think one of the biggest differences from the pre-DSHEA time period is that DSHEA really helped ‘legitimize’ the dietary supplement industry in the minds of many consumers, as it set down specific rules and regulations that manufacturers had to follow in order to be in compliance with DSHEA, such as labeling standards,” noted Daniel McSweeney, owner and president of Vitamin Retailer Magazine Inc.

Gormley Take-Away: So although we must feel fortunate that DSHEA exists, we must remember that the price of liberty is eternal vigilance. In recent years, the Federal Trade Commission (FTC) has picked up where the FDA left off and, by its numerous enforcement actions, “threatens to diminish the industry’s inventiveness for new products that could benefit and support consumer health,” warned Schauss.
 
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