Nutritional Law Supplement Alert: New FDA Rule Regarding Manufacturing Processes

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Overview

Earlier this summer, the Food and Drug Administration (FDA) issued a final rule establishing current good manufacturing practices (GMPs) for dietary supplement companies. The final rule ends the long effort to establish regulations over the nutritional supplement industry. In general, the final rule, which goes into effect today, requires establishing specifications and controls for the manufacturing, packaging, labeling, distribution and holding of nutritional supplements to ensure that such products are of the quality specified and are properly packaged and labeled.

Does It Apply To You, And When Must You Comply?

The GMPs apply to all United States and foreign companies that manufacture, package, label, distribute or hold nutritional supplements in the United States, including both imported and domestic products. The rule does not apply to companies that only supply ingredients for supplements, unless such ingredients are packaged for sale directly to the public. Retail stores are subject to the rule only if they warehouse or hold nutritional supplement products outside of the products offered on the shelves of the store.

The GMPs are effective today, August 24, 2007; however, companies have up to three years to comply with the regulations depending on the size of the company. A company with more than 500 employees must comply by June 25, 2008. A company with less than 500 but more than 20 employees must comply by June 25, 2009, and a company with less than 20 employees must comply by June 25, 2010.

What Do You Need To Do?

  • Written Procedures: Companies must now keep detailed records to document all procedures, operations, manufacturing, training, packaging and quality controls. Specifically, companies must have a master manufacturing record for each formula and each batch size of each nutritional supplement product. All records must be kept for one year beyond the shelf-life date (including the "best by" date), if such date is used, or for two years beyond the date that the last batch of products associated with such records was distributed. All such records must be "readily available" for inspection and copying when requested by the FDA.
  • Identity Testing: Manufacturers who purchase ingredients from suppliers or who create their own ingredients must verify the identity of each substance intended for use in the manufacture of a supplement. The FDA has issued an interim rule that will establish procedures to request an exemption from testing 100% of a product's ingredients based upon quality controls and performance records of the supplier. The FDA is seeking comments on this interim rule until September 24, 2007.
  • Certificates of Analysis: A manufacturer may rely on a supplier's certificate of analysis of inactive or inert ingredients, so long as the reliability of the supplier has been determined.
  • Production and Process Controls: Companies must establish a system of controls for each stage of the manufacturing, packaging, labeling, distribution and holding of nutritional supplements. These controls must be designed to ensure product quality, identity, purity, composition and strength in accordance with the company's master manufacturing record. Companies must also document how such controls assist in ensuring product quality.
  • Finished Product Testing: The rule provides two methods of complying with the mandate that every batch of finished product must be tested to determine whether specifications are met. Companies may test every batch, or companies may sample and test a portion of finished product batches based upon a statistically sound program that is documented to show compliance with quality controls.
  • Complaints: Companies must have a qualified person to investigate and determine if a product complaint involves a potential failure of a nutritional supplement to meet GMP requirements. All returned goods must be quarantined and held until a material review of such products is conducted and disposition determined. Note that if a product complaint involves an adverse event, then the company must follow the requirements of the recently enacted Dietary Supplement and Non-Prescription Drug Consumer Protection Act, Public Law 109-462.
  • Other Provisions: The rule also provides GMPs that cover equipment, instruments, sanitation, personnel, laboratory testing, physical plant, and packaging and labeling procedures.

This law alert gives you a general overview of the new rule. We encourage you to review the rule in its entirety or to consult us before enacting your compliance program.

The GMP final rule can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/07-3039.pdf.

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