14 July 2008

The FDA took dietary supplements seriously

On June 25, 2008, the deadline for implementing the requirements of good manufacturing practices by enterprises with more than 500 employees producing dietary supplements that present their products on the American market ended. Enterprises with a staff of 21-499 employees have another year in stock, two years – with less than 21 employees. The requirements apply to all manufacturers operating in the American market.

The final approval of the rules according to which manufacturers must comply with the current requirements of good manufacturing practice for dietary supplements – Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule (21 CFR Part 111) – the U.S. Food and Drug Administration (FDA) announced on 22 June 2007

"These rules will contribute to ensuring the quality of dietary supplements, and consumers will gain confidence that they are buying exactly what is written on the packaging," said Andrew von Eschenbach (Andrew C. von Eschenbach), commissioner of the FDA, adding: "As a result of recent additions to the federal law on food, medicines and cosmetics, by the end of this year, enterprises will be required to report all cases of serious side effects when using dietary supplements."

cGMP rules will be applied in the production, packaging, labeling and storage of dietary supplements. They contain requirements for the implementation of quality control procedures, design and construction of production facilities, testing of initial components and final products. Also, special rules must be followed when maintaining documentation and working with consumer appeals.

Now manufacturers must evaluate the identity, purity, concentration and composition of their products. If the additive contains impurities or does not contain dietary ingredients, the FDA will consider such a product as adulterated or incorrectly labeled. The purpose of the rules is to prevent the inclusion of foreign substances in additives, too large or small amounts of dietary ingredients, as well as contamination with natural toxins, bacteria, pesticides, heavy metals, etc., as well as to improve packaging and labeling.

There are no specific requirements for validation and audit in the rules. Instead, there are requirements to ensure the functioning of the equipment in accordance with its purpose and to provide documentation establishing the qualifications of each supplier. There is also such a statement: "you should check that laboratory tests and testing methodology correspond to their purpose."

As an accompanying document, the FDA issued temporary rules for manufacturers to submit applications for exemption from compliance with cGMP requirements, ensuring a continuous (100%) verification of the identity of dietary ingredients used in the production of dietary supplements. Also, the manufacturer may be exempt from cGMP, provided that convincing evidence is provided that reducing the frequency of testing will ensure the complete identity of dietary ingredients.

Weekly "Pharmacy" based on the materials of the Food and Drug Administration, www.pharmaceuticalonline.com and www.pharmout.com.au

Portal "Eternal youth" www.vechnayamolodost.ru14.07.2008

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