I spent another afternoon in disbelief, reading over a dozen emails regarding Congress’ improper use of the Dietary Supplement Health and Education Act (DSHEA). They misappropriated the act to pull Ephedra from the market. And now they’re trying to oust vitamin E!
Next stop… the rest of the alphabet.
In fact, there are so many levels to this issue that I have included many valuable links for you to get the full story from all sides. And since the story is so vast, I will present it as an ongoing series. This is just the first installment.
Since the beginning of America’s founding we citizens have been avid users of natural products for health. At the same time, we’ve been clamoring for our government to keep the bad stuff off our shelves. And while the times of dishonest “snake oil salesmen” are mostly gone, the day of the government ban is on the horizon.
But this has not always been the case.
With Best Intentions…
In 1958, the FDA added the Food Additive Amendment to the Federal Food, Drug & Cosmetic Act (FD&C). This was done to ensure consumer safety against unsafe supplements and their untrue labeling or misrepresentation of their benefits. We Americans spoke up for the protection of our health and lifestyle choices and our cries were heard.
In 1995, former President Bill Clinton signed the 1994 Dietary Supplement Health and Education Act (DSHEA). It was another amendment to the FD&C. In essence, the Act makes sure that since natural supplements are considered “food” as opposed to “drugs,” they remain available to consumers who wish to include them as a part of their healthy lifestyle choices. And since Congress cannot control how many carrots you eat, it shouldn’t control the amount of vitamin A you consume, either.
The passing of DSHEA was thus considered a massive victory for consumers. The act was Congress’s answer to consumer concerns about their health. In fact, Clinton stated, “The passage of this legislation… speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them.”
With the Riches Come the Spoils
It seems the passing of DSHEA also created a loophole for non-health-friendly members of Congress and the FDA to take our health choices from us.
You see, while these bills appear to protect the public, they actually make it easier for government agencies to control supplement use… or take them off the market completely! And it seems that while it’s the FDA’s job to protect consumers from fraudulent claims being made against the guise of “studies,” it has done nothing in the case against natural herbal, vitamin or mineral supplements.
At least five bills have been introduced in Congress in recent years that would affect your right to access dietary supplements. In fact, only the Hatch Harkin Bill S.1538 proposed the FDA should support the DSHEA rather than fight against it, or merely stand by and do nothing. However, the bill recognized that the FDA requires more money to do its job. It proposed $100 million in funds be allocated for this purpose.
The most recent bill is the Dietary Supplement Safety Act S.3002, introduced in February by Senator John McCain (R-Ariz.). The bill would change existing mandatory serious adverse reporting regulations, requiring even minor adverse effects to be reported so that the FDA could arbitrarily pull supplements off the shelves or reclassify them as drugs, according to jbs.org.
Opponents of the bill say the regulations would be ripe for abuse, with minor, unrelated or trumped-up evidence of adverse effects leading to supplements being classified as drugs and pulled off shelves.
Trumped-up “evidence” and certainly misuse of herbals was the cause of the Ephedra ban. Ephedra, known as ma huang in traditional Chinese medicine, has been a staple in formulas used to treat asthma, bronchitis and other lung diseases. In the proper dose and for the proper use (inducing sweating to relieve damp heat in the lungs), ma huang is a strong and natural aid for health. But when formulated in much higher doses for use as a metabolism enhancing agent in weight loss supplements… serious problems occurred. And now, because of misuse, the herb is off the market in the U.S.
In fact, the Washington law firm, Hyman, Phelps, and McNamara, P.C. believes the Ephedra rule will endanger all vitamins. Read their “Legal Opinion Regarding FDA’s Ephedra Rule.”
Vitamin E is the target of a similar smear campaign. Yes, that’s right, the same vitamin E used in skin care products and as an immunity aid against free radicals. The government is now calling it “risky.” Yet the cases presented as “proof” were people who suffered pre-existing diseases.
You see, these bills include the Adverse Event Reporting (AER), which is not necessarily bad. However, AER is now being used by dishonest people (in the government and outside of it) as an excuse to bring the industry (and our rights) to its knees. Anti-vitamin stories are surfacing as “proof” that supplements should be banned. These include deaths not related to supplements, but the people happened to also be taking supplements of some kind. And this is the gist of the vitamin E situation.
United We (Must) Stand
It is imperative that we not allow Congress, the FDA, the media or unscrupulous individuals to keep us from seeking and maintaining optimal health by regulating or banning natural supplements. They are only food in another form. They are part and parcel of the daily health choices we make that come with America’s freedom.
The implementing of AER for herbs, minerals and vitamins is as nonsensical as implementing it for a turkey sandwich! The FDA is more worried about the amount of vitamin E we take than the true and severe side effects of synthetic pharma drugs. I find that disturbing. And if this passes, perhaps hundreds of thousands of people could start blaming supplements for their ailments. And the resulting class action lawsuit would be devastating not only to supplement manufacturers’ insurance costs, but to the accessibility of such supplements in the future.
Our only hope is to fight back and stand up for our health rights. Imagine, no more One A Day®, no more calcium tablets, no more B-complex.
In response to the actions of Congress, the Nutritional Health Alliance has activated the Save and Strengthen DSHEA campaign. Visit the NHA site and access the names and addresses of your Congressmen and Senators. Sample letters are there to view, as well as necessary phone and fax numbers.
We need your help. You need your help. Let’s all take a few moments and do our part before it’s too late.
—Dr. Mark Wiley