The significant regulatory risks for noncompliance must be considered when a brand looks into choosing a contract manufacturing partner for a dietary supplement product.
For a number of years, many dietary supplements have been produced by contract manufacturers. As manufacturing processes become more sophisticated (e.g., complex probiotics) and FDA regulatory requirements continue to expand, it becomes more cost effective to use the knowledge, experience and expertise of contract manufacturers to produce these products. Due to increased costs in manufacturing and testing equipment, many companies find it is a more economical option.
Entering into a partnership with a contract manufacturer can offer many advantages. However, it also presents several challenges to ensure the products are being manufactured in accordance with all applicable laws and regulations. The following statement is often seen in warning letters regarding the manufacturing of dietary supplements.
“In cases where a distributor contracts with a manufacturer to manufacture a dietary supplement that the distributor then distributes under its own label, the distributor has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution.”
In addition to that FDA statement, court cases such as U.S. vs Dotterweich and U.S. vs Park clearly establish corporate officials must “devise whatever measures are necessary to ensure compliance with the Food, Drug and Cosmetic Act.” (from the Park case).
Some of the compliance issues identified by FDA and EAS consultants—and strategies the firm recommends for compliance—follow.
Contract Manufacturers’ Findings
FDA dietary supplement cGMP (current good manufacturing practice regulations in Title 21 of the Code of Federal Regulations ( CFR ), Part 111, “Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,” were published in 2007. When looking at recent statistics for warning letters issued to the industry, the following were most often observed:
