Final rule promotes safe use of dietary supplements

Some dietary supplements are beneficial when taken appropriately. Calcium supplements may strengthen bones and folic acid lowers the risk of certain birth defects. But some supplements pose
health risks. They may contain harmful ingredients or be improperly manufactured or handled.

On June 22, 2007, FDA announced a final rule establishing current good manufacturing practice requirements (CGMPs) for dietary supplements. In addition, by the end of the year, industry will be
required to report all serious dietary supplement adverse events to FDA.

Ensuring Quality
Under the final rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of dietary supplements.

“The dietary supplement CGMPs should increase consumers’ confidence in the quality of the dietary supplement products that they purchase,” says Robert E. Brackett, PhD, Director of FDA’s Center
for Food Safety and Applied Nutrition. “These regulations provide more accountability in the manufacturing process so that consumers can be confident that the products they purchase contain
what is on the label.”

The final rule aims to ensure that dietary supplements do NOT have:

● wrong ingredients
● too much or too little of a dietary ingredient
● improper packaging
● improper labeling
● contamination problems due to natural toxins, bacteria, pesticides, glass, lead, or other substances

How FDA Regulates Supplements
The final rule on CGMPs is a critical component of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Under DSHEA, dietary supplements are regulated like foods. Unlike new drugs, dietary supplements don’t have to go through review by FDA for safety and effectiveness or be “approved” before they
can be marketed. But manufacturers must provide premarket notice and evidence of safety for any supplements they plan to sell that contain dietary ingredients that were not marketed as dietary
supplements before DSHEA was passedâ€â€Âexcept that the premarket notice is not
needed if the new dietary ingredient had previously been used as in ingredient in food.

Manufacturers are responsible for substantiating the safety of dietary ingredients and also for determining that certain structure/function and other claims they make about their products are
substantiated by adequate evidence to show that the claims are truthful and not misleading.

FDA evaluates the safety of dietary supplements after they are on the market through research and adverse event monitoring. The agency is responsible for taking action against any unsafe
dietary supplement product after it reaches the market.

The final rule on CGMPs gives industry clear expectations for manufacturing, packaging, labeling, and holding dietary supplements. If dietary supplements are found to be contaminated or lacking
the appropriate ingredients, FDA will consider those products in violation of the law and will evaluate its enforcement options.

Advice for Consumers
● Talk with a health care provider before using a dietary supplement. This is a good idea, especially for certain population groups. If you are
pregnant, nursing a baby, or have a chronic medical condition such as diabetes or heart disease, be sure to consult your doctor or pharmacist before purchasing or taking any supplement.
● Know that some supplements may interact with prescription and over-the-counter medicines. Taking a combination of supplements or using these products
together with medications (whether prescription or OTC drugs) could produce adverse effects, some of which could be life-threatening. For example, Coumadin (a prescription medicine), ginkgo
biloba (an herbal supplement), aspirin (an OTC drug), and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for
internal bleeding.
● Inform your doctor about all the supplements you use, especially before surgery. Some supplements can have unwanted effects during surgery. You may
be asked to stop taking these products at least 2-3 weeks ahead of the procedure to avoid potentially dangerous interactions. These interactions could cause changes in heart rate or blood
pressure, increased bleeding, or other problems that could adversely affect the outcome of your surgery.
● Report adverse effects from the use of dietary supplements to MedWatch. If you think you have been harmed by a dietary supplement, contact your
health provider and report it to FDA’s MedWatch program by calling (800) FDA-1088, or visiting

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