New Accuracy requirements for supplements….

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Today's post: Monday, 6-25-2007

New Accuracy requirements for supplements….

News online late last week had two stories on this -- one from AP & one from Reuters.

I’ve often wondered myself if some of the least expensive supplements have the amount of their ingredients stated on the label. Some tests of several supplements from different companies each claiming to have a certain amount of a kind of particular supplement have indeed found that some do have the ingredients in the amounts stated; but many contain much less. I was told by someone in the industry that supplements from the major companies usually do contain the ingredients in the amount stated. But I’ve thought for a long time that it would be nice to be able to know for sure.

And, I have read that some supplements, particularly those from outside the United States, have been found to have real drugs in them. So far, I simply haven’t considered taking supplements from outside the United States for that reason. Supplements have a very good track record of being side effect free. But quite often drugs do not. Even worse, some drugs can have dangerous interaction effects; & some people are allergic to certain drugs. So, it’s really important to know if you are taking a specific drug for several reasons.

So, I was mostly pleased to see this news story that these things will happen soon.

Most of the major companies will likely just be a bit more thorough in the record keeping they are already doing of tests that insure their products have what they are supposed to have. And, they have been selling supplements that have only the stated ingredients. But they may have some price increases at first to cover the extra record keeping or more frequent testing they may need to do.

Second, smaller & newer companies will have to begin testing their supplements & keeping detailed records. And, their prices will very probably go up.

The good news is that the companies that have been making supplements that are ineffective due to too little of the ingredients in them or that are possibly unsafe from adding drugs will either make good supplements or stop making & selling any. Their prices will very likely also go up if they continue in the supplement business.

Could this new law wind up over-controlling supplements later through expanded but much less desirable functions being added to it at a future time? Possibly.

But, in the current version, the trade off of the small & mostly temporary price increases for the real reassurance that the supplements you buy have enough ingredients to work & contain no dangerous drugs seems well worth it to me.

Here are some excerpts from the AP version of the story:

“FDA issues new safety rules for vitamins

By KEVIN FREKING, Associated Press Writer Fri Jun 22, 8:28 PM ET

WASHINGTON - 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 said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain 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, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an 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 — are a $22 billion industry.

Most companies already test their raw ingredients, 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. 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.

Consumers Union, publisher of Consumer Reports, called the rule a good step toward improving consistency in the ingredients that go into supplements.

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.

"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.” “