FDA Cracks Down On Dietary Supplements

New Regulations Mandate That All Ingredients In Products Must Be Tested

(AP)  For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients, the Food and Drug Administration announced Friday.

The agency is phasing in the new rule, which is designed to address concerns that existing federal regulations allowed supplements onto the market that were contaminated or didn't contain the dietary ingredients claimed on the label.

Last year, the agency found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.

If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim to contain, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove the ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.

Dietary supplements; pills, liquids or other products people take to improve their diets; are a $22 billion industry.

Most companies already test their raw ingredients once they come into the plant, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.

"This raises the bar so that all have to comply," Mister said.

The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. However, even the largest of the manufactures won't have to comply until June 2008.

The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S. It requires them to analyze the identity, purity and strength of all the ingredients that go into their products before they are distributed.

It also includes requirements for record keeping and handling consumer complaints.

Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.

"You still don't have to show the product is safe. You don't have to prove it works," said Wolfe, director of Public Citizen's Health Research Group.

Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop. Under the old regulations, supplements were governed by the same rules that applied to producing foods.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition.

[rushlimpdrug]

It is about time.
Seems I've gained more weight after starting the twinkie diet.
The donut diet didn't do it for me either.

[drinuk]

Cont. The FDA hypocracy was further highlighted last week in the UK. Aspartame was initially banned by the FDA, then low and behold suddenly got approval when Mr Rumsfelt came to office. Two major food retailers in the UK announced that they were to ban all food and drink containing this alleged poison, Both Marks and Spencer and Asda/Walmart stated that following a study by the Foods Standard Agency into ADD in children they would quickly phase it out. In Italy, independent research has found possible link between Aspartame and Brain Tumours. Did the FDA jump on these reports ? NO! They announced this Micky Mouse, Big Pharma promoted restraint on vitamins. The whole thing stinks to high heaven and proves beyond any reasonable doubt that the FDA work for Big Pharma and not the American people.

[drinuk]

Before this story goes any further let us fully check out Mr Wolfes involvement and the fact rightly stated here that Big Pharma want a big slice of the millions mentioned. Let us find out just where He is coming from ??

Whilst it is correct that all products sold to the public should contain what is stated on the tin, there is no doubt that the FDA are indeed acting on behalf of the pharmaceuticals on this matter.

Make no mistake, this is not about Vitamins, it is about natural cures and prevention of serious diseases. It is about the Apricot Kernel, it is about Graviola, Bitter Melon and many other Natural products Big Pharma cannot obtain a Patent on. It is about the rape of health care systems worldwide and it's about curtailing the use of Vitamin C as a preventative to cancer.

As a caveat to Big Pharma and the FDA I would suggest they seriously take heed of Luke 8-17., "For there is nothing hidden that will not be disclosed, and nothing concealed that will not be known or brought out into the open" The people are learning of the deciept and corruption, the day of reckoning is drawing closer. The Billions of dollars spent lobbying politicians will all have been in vain.

[randompaths]

Talk about the pot calling the kettle "black"... The FDA has, through their pandoring to big pharmaceutical companies, killed more people than dietary supplements...bar none.

The FDA should be investigated, prosecuted, and disbanded. And news organizations that receive their press releases and run with them (press releases = propoganda) should be held to the fire of the American public.

The FDA is a bureacracy that has outlived (and not met) its purpose. Time for something that works. Pharmaceutical companies are behind the move to limit supplements. They want to eventually require you to go see a doctor, in order to get vitamins and minerals. Our government is out of control, because the public is not watching. Wake up. Another one of your freedoms is about to disappear.

[fenderhutz]

Hmm, an overpriced weight loss drug becomes an over the counter remedy and the FDA announces it's going to crack down on supplements.

The supplements I take don't require a spare pair of undies.

Too much of a coincidence for this one. Need to stoke the fire while it's hot I guess.

[uradufuss]

What a joke. Now it's time to target the major drug companies, and get the FDA off of their payrolls. Let's force them to stop using the genral population as their guinea pigs, and get all of the viagra commercials off of the TV.

[dontbasucka]

It's mostly about China, the other world superpower and now top CO2 producer: http://edition.cnn.com/2007/TECH/science/06/20/china.climate.ap/index.html
-dumping poisons into what some think are miracle cure super supplements. They screwed with our toothpaste & pet food that ended in deaths. If the U.S. had introduced a poisonous substance into products our media would have crucified them.
Instead, our mainstream media outlets play down these situations, dilute the focus and a few communists are labeled as greedy thugs & we continue the trade. How did antifreeze ingredients get into toothpaste? Do you really think our Chinese friends manufacture toothpaste, antifreeze, and solvents in the same facilities?
Something about communists being the top food producer in the world just doesn't make sense. Poisons? Slave Labor? Are they really just like us?

[Rontimcoe]

This is all about the drug companies and the 22 billion that the otc trade is worth.

[kimfin01]

It's all about money...They will actually have to start making sure that what they say is in the supplement is in them and not some filler that could be unhealthy to ingest.

[erasmus6]

And WHY haven't they been regulated before now?