FDA Issues Ruling Concerning Diet Supplements

The Food and Drug Administration made a final decision regarding diet supplements on Friday, according to a press release on the Food and Drug Administration's website. The decision established a rule regarding the manufacturing, labeling and ingredients included in diet supplements.

According to the Food and Drug Administration's press release Andrew C. von Eschenbach, Commissioner of Food and Drugs had this to say regarding the rule: "This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label. In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.".

The new Food and Drug Administration's rule brings long overdue regulation to the dietary supplement industry. The rule now requires dietary supplement manufacturers to, among other things, follow regulations for quality control procedures, construction and design of manufacturing plants, and testing ingredients, completed product, handling consumer complaints, and record keeping.

Before the ruling manufacturers were not required to analyze their products for purity, strength or composition.

The Food and Drug Administration maintains that new rule will help prevent contaminations from toxic chemicals, metals, and bacteria. The new rule will also make certain that supplements do not contain improper amounts of dietary ingredients and make sure that the supplements are properly labeled, according to the Food and Drug Administration's website.

The Food and Drug Administration has taken steps to make certain that manufacturers are not adversely affected by the new ruling by allowing exemptions to certain parts of the ruling for qualifying companies. Manufacturers wishing an extension to the ingredient identity testing portion of the rule must file an application. However, the Manufacturer must provide evidence that the identity of the proposed ingredients can be adequately ascertained with less testing.

The ruling will become effective on August 24th, 2007. The Food and Drug Administration has provided a phasing in program for small manufacturers to allow them time to comply. Qualifying small manufacturers will be allowed three years to phase the changes required in the rule in, according to the Food and Drug Administration.

The Food and Drug Administration is requesting public comment, during a 90 day comment period set to end on September 24th, 2007. Comments can be submitted to the Division of Dockets Management Branch by clicking here.

Sources:

The Food and Drug Administration