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November 15, 2011 | Comments: 0

GMPs for Dietary Supplements: Do the New Rules Go Far Enough?

Critics have long warned that you don’t really know what you’re getting when you buy dietary supplements. Do new “GMP” rules from the FDA make a difference?  

Over the years there have been numerous reports of dietary supplements containing much less, or much more, than what’s listed on the labels. Worse yet, supplements have been found to contain undisclosed prescription drugs, as well as contaminants such as lead and other heavy metals. 

To address these concerns, the FDA issued final rules in 2007 that require dietary supplement makers to follow more extensive “good manufacturing practices” (GMPs) to ensure the identity, purity, strength and composition of their products.

Since the Dietary Supplement Health and Nutrition Act (DSHEA) went into effect in 1994, dietary supplements have been regulated under the category of food—and as such, they’ve been covered by GMPs that basically check for sanitary conditions and consistency in production. The newer GMPs, however, are specific for dietary supplements and impose higher standards on these products than food GMPs do. For example, companies are supposed to test all raw materials, set expiration dates based on documented science, ensure that workers are appropriately trained and follow proper procedures, and keep more extensive records, subject to FDA inspection.

Where the GMPs for dietary supplements fall short

But the final rules were watered down from the original proposals. Not surprisingly, manufacturers fought against measures that would increase costs. What’s more, the FDA, despite increased funding and a pledge to substantially increase inspections, still lacks the resources to fully monitor compliance, which is done primarily through inspection of paperwork, not facilities.

Though the GMPs are supposed to ensure that supplements contain what their labels say, manufacturers can still cut corners and make poor-quality products. The FDA has also been criticized for allowing some companies to be exempt from testing all their ingredients or products, for not setting lead or pesticide limits in supplements, and for a range of other holes and loopholes.

What to keep in mind

GMPs for dietary supplements don’t guarantee safety. Ingredients can still have side effects and unknown long-term effects, interact with drugs and be dangerous if you have certain medical conditions. They have nothing to do with whether a product “works.” And the GMPs do not change how dietary supplements are labeled. Unlike labels on drugs, those on supplements still need not list any precautions, contraindications or possible interactions.

Moreover, many dietary supplements still fail to meet quality standards when put through random testing. GMPs should improve matters somewhat, but it will take time. And there will always be a few bad apples in the bushel, no matter how vigilant the FDA may be.

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