The FDA vs the Supplement Industry

[stuntmovie]

In an attempt to bore every GetBigger who ever existed except for a couple of GetBig intellectuals (Is that even possible?), I'm going to make an effort to explain the background behind the FDA's attempts to 'put a leash on' (or the FDA's attempt to control)  the supplement industry since those good old days starting around 1941.

ACTUALLY, I'm submitting this information with the help of a number of web-sites due to the fact that most GetBiggers actually believe that there is a certain amount of fraud within the supplement industry ... especially when it comes to advertising various products that make monumental claims within muscle related magazines and on internet web-sites.

And the more intelligent intellectuals among us often ask, "Why does the FDA not do something about it?!"

So this will be my attempt to answer that question which is most likely keeping most GetBiggers awake and in deep thought  throughout the evening hours!

Once again that question is, "WHY DOES THE FDA ALLOW THE SUPPLEMENT INDUSTRY TO MAKE NUMEROUS QUESTIONABLE CLAIMS REGARDING THEIR PRODUCTS?"

Some GetBiggers may find the answer to that question to be very interesting ...... But you will have to read  a lot of the following to fully understand that answer.

It's definitely NOT a one trick pony!

But I'll do my best to make it as simple as possible!

[drkaje]

I always thought the FDA's goal was to protect people from their own ignorance and gullibility.

[stuntmovie]

Well, you're kind of right, DK, but to be more accurate  .......

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States.

You will be finding out that the FDA is not as powerful an agency as you probably think it should be.

[youandme]

Aren't there like 3 supplement manufacturers and a lot of these supplement companies use these manufacturers for their products?

I heard Dymatize was bought out a few years back and that their manufacturing plant (which was basically shit) was closed and the manufacturing process was sourced elsewhere.

[FREAKgeek]

Once again that question is, "WHY DOES THE FDA ALLOW THE SUPPLEMENT INDUSTRY TO MAKE NUMEROUS QUESTIONABLE CLAIMS REGARDING THEIR PRODUCTS?"

They don't, you're just required to have the above.

[_aj_]

Because many supplement giants are located in Nevada AND
They bring billions in tax revenue to the state AND
One of the most corrupt politicians, Harry Reid, is the senior senator from Nevada.

[drkaje]

They don't, you're just required to have the above.

That statement doesn't instantly remove a product from being under FDA authority.

[BB]

This Frontline documentary is pretty good about all the false claims, and dangerous things that can make it into supplements. It also goes into all the rejiggering and lobbying the supplement did to weaken government regulation back in the 80's - early 90's -

http://www.pbs.org/video/2365646371/ .

[FREAKgeek]

That statement doesn't instantly remove a product from being under FDA authority.

everything is under their authority, if it's not a drug it's just loosely regulated until there is evidence that it's unsafe. Then they have the authority to pull it off the shelves (like what happened to ephedra). It is just saying don't expect or rely on the product to do anything.

[stuntmovie]

Thanks, There are some good questions/comments up above, but keep on reading cause some of this factual stuff may answer your concerns and bring rise to further interesting questions.......

[drkaje]

Thanks, There are some good questions/comments up above, but keep on reading cause some of this factual stuff may answer your concerns and bring rise to further interesting questions.......

I deal with them in a limited capacity when it comes our product's 510(k), facility recertification, product changes and silliness like that.

[stuntmovie]

Before I respond to any of the above comments, lets continue with the FDA's mission .....

Their mission includes protecting the public health by assuring the safety, efficacy, and security of human medications. Vitamin control would naturally fall into this mission.

But as were shall soon see ....... this was unacceptable to certain groups who wished to gain unprecedented power to sell unproven products without FDA oversight.

Their approach to eliminating the FDA from the picture was ingenious and ultimately effective.

A coalition composed of health food stores, supplement users, the supplement industry, lobbyists, and sympathetic members of Congress created a new class of products and simultaneously declared that this new class would not be subject to the mission of the FDA.

(At the time that this was going on, I was in complete agreement with any  opposition towards the FDA.).

So now it's time to head back to 1941 ........ way before the above mentioned 'coalition' took place!

[stuntmovie]

It all started with a label!

It was 1941 and the FDA established regulations in to govern labeling of vitamins, establishing a Minimum Daily Requirement (MDR) for each vitamin.

But the FDA failed to restrict the amount of a vitamin allowed in supplements at that time.

So some unscrupulous manufacturers and marketers took advantage of the situation and made outlandish claims for vitamins and other dietary supplements.

In many cases, those claims included incorrect information alleging that megadoses of vitamins were safe and more effective than the normal doses.  (Some doctors today still claim that vitamin mega-dosing  is  most beneficial.)

The FDA recognized the medical dangers of these claims, but was only able to move against the manufacturers and marketers on a case-by-case basis under their outdated and incomplete 1941 regulations.

The unwieldy case-by-case process would have consumed far too much time and resources given the multiplicity of offenders.

Thus, the FDA realized that the solution was to establish stronger regulations that would help the agency control the burgeoning national problem.

So .....  in 1962, the FDA attempted to revise the 1941 regulations to adopt the Recommended Daily Allowance (RDA), and more importantly, to restrict the amount of each vitamin in any product to 150% of the U.S. RDA, and only allowing a few combinations of vitamins to be marketed as dietary supplements.

The FDA also attempted to require the following disclaimer on vitamin supplements: "Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements."

Somewhat surprising hearings were held from 1968 to 1970 and the FDA was forced to withdraw the proposed disclaimer, although a majority of the proposal remained intact.

Any product with more than 150% of the U.S. RDA (Recommended Daily Allowance) would have required review and approval by an FDA OTC expert advisory review committee.

In 1973, the proposal was finalized in the Federal Register which is the  the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices.

This move generated intense controversy.

(The Plot Thickens!)

[stuntmovie]

Immediately after the FDA regulations were established, the dietary supplement manufacturers moved quickly to mobilize congressional support to completely invalidate those regulations.

Through the efforts of the manufacturers, the 1973 regulations were overturned, remanded to the FDA by legal action,  and eventually revised and reproposed by the FDA in 1975.

During this time, Senator William Proxmire (D-Wisconsin) became the standard bearer for the supplement industry who sponsored the 1976 Proxmire Amendment.

This amendment  prohibited the FDA from establishing standards to limit the potency of vitamins in food supplements or regulating them as drugs based solely on their potency.

Thus congressional interference with the FDA virtually negated its mission of protecting the American public from dangerous doses of vitamins.

On October 19, 1976, the FDA issued a revised final regulation establishing standards for vitamins that conformed to the Proxmire Amendment but it  was still unacceptable to the dietary supplement industry and its supporters.

In 1968 the regulation was vacated by the U.S. Court of Appeals and  was remanded to the FDA for further consideration.

The court ruled that the Proxmire Amendment had profoundly changed the FDA's authority over vitamins and that further time for public notice and comment would be needed.

On March 16, 1979, the FDA published a notice in the Federal Register stating that its dietary supplement regulations were revoked.

In 1979 the FDA published its Proposed Rule in the Federal Register which would have allowed the FDA to assert authority over vitamins, minerals, and hematinic drug products when they were labeled with drug claims and sold as OTC products.

However, that was coincidentally the same issue of the Federal Register in which the FDA revoked its own vitamin regulations.

So now it appears that everyone is confused.

[stuntmovie]

Due to the fact that both documents were made public on the same day health professionals and the general public were confused and outrage ensued.

The FDA received thousands of letters protesting the 1973 Panel Report, which was misperceived as a move either to restrict vitamins to prescription status or to undermine the Proxmire Amendment.

Congress became involved again, threatening the FDA with legislation to further restrict its role in vitamin regulation.

The FDA was unable to correct the misinterpretations and, as a result, was forced to withdraw the proposed monograph in 1981 but the agency stressed that it retained the ability to take action against OTC vitamins that were unsafe or misbranded.

[stuntmovie]

The tryptophan Tragedy of late 1989  which caused he death of  38 individuals caused the FDA to take  immediate action to recall the products.

Eventually, the problem was discovered to be related to manufacturing processes but it did encourage the FDA to examine the entire dietary supplement industry.

On July 29, 1993, FDA Commissioner David Kessler presented a report to the House of Representatives detailing the agency's finding regarding the entire dietary supplement industry.

Next up ... The Commissioner's report to the House of Representatives.

[stuntmovie]

NOTE: These findings may not apply today. This report by the FDA Commissioner about the supplement industry at hat time was presented to the  House of Representatives on July 28, 1993 and it is possible that things are  completely different today.

The FDA Commissioner's report noted that about 80% of the dietary supplement industry (at that time) consisted of vitamins and minerals that made no unsubstantiated claims, but the balance consisted of products that presented safety concerns (some serious and life-threatening) or made thousands of unsubstantiated claims in catalogs, brochures, and sales pitches.

The agency concluded that, if the trend continued, the U.S. would return to the days of the turn-of-the-century medicine shows.

The FDA's investigators visited health food stores on an undercover basis to ask if anything was available for cancer.

They were sold antioxidant vitamins, germanium, ginseng, shark cartilage, red clover, Venus flytrap, bee pollen, herbal teas, lion's tooth, saw palmetto, honeysuckle, aloe vera, pancreatic enzymes, and colonic rinses.

Despite its devastating findings, the FDA's well-documented report was attacked by the president of the National Nutritional Foods Association  which educates members of Congress about the industry and the impact of federal legislation and regulations. In addition, NPA provides comments to federal agencies on how regulatory enforcement activities may affect manufacturers, retailers and consumers of natural products and dietary supplements.

And once again the plot thickens!

Sorry but there's more!

[The Abdominal Snoman]

Great thread Stunt.

[stuntmovie]

Thanks, AB! I'm learning a lot about this myself. Most surprising to me is the fact that the FDA does not possess the 'clout' to make changes without government or outside interference.

I'm hopeing to wrap this up this afternoon.

I think that the next part may be the major surprise to those who are interested in this subject.

[stuntmovie]

OK, so now it's President George Bush's turn to get involved ...

On November 8, 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA), which required foods and dietary supplements to bear nutritional labeling.

The FDA issued proposed rules to implement NLEA, stating that companies were making fraudulent claims, that vitamins would be held to the same standards as other medications, and that any claims would be required to withstand scientific scrutiny.

The supplement company lobby issued immediate opposition.

Health food stores disseminated leaflets stating that NLEA was a disgrace and that failure to write Congress would result in the FDA removing vitamins and minerals from store shelves.

The resulting letter-writing campaign flooded congressional offices.

(The shit begins to fly!)

[stuntmovie]

Now the health food stores and supplement lobbies worked assiduously to ensure that the FDA would not be able to retain any control over vitamins through the NLEA nor any other method.

This time the supplement industry driving force was Senator Orrin Hatch (R-Utah), who bore major responsibility for the resulting Dietary Supplement Health and Education Act (DSHEA) of 1994 which was signed into law by President Bill Clinton.

The DSHEA law was intended to permanently prevent the FDA from enforcing the NLEA in regulating dietary supplements such as vitamins.
 
Now the manufacturers were not required to provide information to the FDA prior to marketing.

Thus, DSHEA eliminated the FDA premarket review and approval of dietary supplements, and also removed the FDA's authority to test dietary supplements.

As a result, the necessary controls that the FDA was legally able to exert over prescription products were completely invalidated for dietary supplements such as vitamins, minerals, herbs, botanicals, and amino acids.

[stuntmovie]

Under DSHEA, dietary supplement manufacturers were allowed to make unproven claims about the effect of the supplement on the structure or function of the body.

The only notification the consumer would receive of the unproven nature of the claim(s) was the required disclaimer:

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

[stuntmovie]

If anyone has read and has a slight comprehension of the above ....It should be readily apparent that the FDA gradually lost the authority to regulate dietary supplements containing vitamins in the same manner as legitimate nonprescription medications and prescription medications are regulated.

ANY UPDATES OR RECENT CHANGES WITHIN THE LEGALITIES OF THE SUPPLEMENT INDUSTRY WOULD BE SINCERELY APPRECIATED.....

[stuntmovie]

"AND THEY LIVED HAPPILY EVER AFTER!"

FINI.....

[stuntmovie]

YOUANDME asked a decent question about the relatively small number of companies who actually manufacture supplement products on the behalf of the vast number of companies whose name they bear.

That would be interesting to ascertain b ut I have no idea at the present.

But the following four do have decent websites regarding the subject matter which some enterprising GetBiggermay want to contact.

Supplement Manufacturers USA
NutriScience
Makers Nutrition
Hi-Tech Pharmaceuticals

Someone on here might know who supplies the big name brands.