FDA proposes quality standards for supplements
Source: Diabetes Forecast
Publication date: 2003-09-01
Arrival time: 2003-09-02
DIETARY supplements have never come under the regulatory scrutiny applied to prescription drugs. For example, prescription drugs cannot be sold unless they have been proven safe and effective in good scientific studies. Afterwards, companies are required to tell the Food and Drug Administration (FDA) about any reports they receive of injuries or illnesses possibly caused by their drug.
Not so with dietary supplements (except in the case of new dietary ingredients, where pre-market review for safety data is required by law). FDA does not review label claims for vitamins, minerals, botanicals, and other supplements, nor does it test supplements in any way. Each company sets its own manufacturing standards and safety procedures. As a result, supplements may sometimes contain drugs, contaminants, or other ingredients not listed on the label. Or a dose may contain much more or much less active ingredient than claimed.
FDA is taking a first step toward making supplements safer. In March 2003, FDA proposed a new regulation. It would require supplement makers to follow good manufacturing practices and to have more accurate labels.
The Proposed Regulation
Here are some high points of what FDA is proposing to do.
* FDA will establish what it calls "current good manufacturing practices" to reduce the chances of tainted or mislabeled supplements reaching the shelves.
* FDA will establish standards for the supplement industry so that supplements from different companies will be manufactured in a consistent manner and labels will provide accurate information about identity, purity, quality, strength, and composition.
* The standards will include requirements for designing and constructing manufacturing plants.
* Companies will need to follow standards for quality-control procedures, testing ingredients and products, maintaining records, and handling consumer complaints.
These rules will apply to all foreign and domestic firms that distribute these products in the United States.
FDA gathered comments on the proposed rule in Spring 2003. Those comments may alter what FDA proposes. The date the rule will go into effect had not been decided at press time. However, FDA has proposed a three-year phase-in for small companies.
Possible Benefits
FDA hopes to prevent several kinds of problems and achieve several benefits for consumers with the new rule.
One problem with supplements has been low quality. FDA expects that good manufacturing practices should make it less likely that a supplement would contain too little active ingredient, too much active ingredient, the wrong ingredient, contaminants such as bacteria or lead, tablets that vary in size or color, too few tablets, a drug that's not listed on the label, or incorrect labels.
As a result, consumers should be better off. They will still be able to buy dietary supplements without any new restrictions. But they will be more confident that a supplement contains what the label says it does and that the purity, strength, and quality match the label's claims. Also, scientists will be able to do more reliable studies on supplements once supplements are manufactured to a consistent level of quality.
What The New Rule Doesn't Do
FDA's new rule deals only with setting quality standards for manufacturers to prevent many of the quality problems that now affect the supplement industry.
Consumers arc still on their own when it comes to the safety and health effects of supplements. The new rules do not require any proof that a supplement contains only safe ingredients or even that it works. Companies still do not need to notify FDA of possible harmful effects that users report. So the old catchphrase "caveat emptor" (let the buyer beware) still applies.
BY SHAUNA S. ROBERTS, PHD
Copyright American Diabetes Association Sep 2003
Publication date: 2003-09-01 |
