Dietary Supplement Manufacturing Requirements

In fiscal year 2019 fy19 dietary supplement manufacturing facilities issued an inspection report or so called form 483 for violations of cgmps current good manufacturing practices were most commonly cited for failing to establish specifications for.

Dietary supplement manufacturing requirements. Fda is disappointed with continuing violations of basic manufacturing requirements applicable to the dietary supplement industry. With nearly 20 years of direct to consumer and business to business experience mr. Federal register for the final rule june 25 2007.

Vincent tricarico is currently the vice president of contract manufacturing at nutrascience labs. The program is open not just to manufacturers of dietary supplements but also to manufacturers of ingredients. Food and drug administration s fda final regulation on good manufacturing practices gmps for dietary supplements established stringent requirements for companies involved with the manufacturing packaging labeling and holding of dietary supplements.

Enhancing a product s appearance and shelf life. Includes guidance for industry as well as manufacturing processes food facility registration haccp retail food protection. In addition an audit requirements guideline arg were published as companion documents to assist with the interpretation of each standard.

The federal food drug cosmetic act defines a dietary ingredient as a vitamin mineral herb or other botanical and or amino acid. Improving product quality consistency and manufacturability. Aiding with packing and transportation.

The primary purpose of processing aids in dietary supplements is to facilitate the manufacturing of products which includes but is not limited to. Nsf international independently certifies manufacturers as meeting gmp requirements. Tricarico is a respected executive in the dietary supplement industry and is well known for his ability to consistently build and grow successful teams that produce results.

By the dietary supplement industry in accordance with 21 cfr part 11 21 cfr part 111 and food safety modernization act fsma. These supplements all have the usp dietary supplement verified mark on their labels. Supplement makers are all supposed to follow fda rules discussed in the section called dietary supplements are considered safe until proven unsafe but the usp mark indicates that they choose to follow even higher quality standards.