Key provisions of final regulation identified
As reported earlier today to members, the U.S. Food and Drug Administration (FDA) released its long-awaited final regulation on good manufacturing practices (GMPs) for dietary supplements. The rule, according to the FDA, will ensure that “dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.”
“We think the final regulation is strong, but more reasonable than the proposed version. It offers a more flexible framework in meeting standards, such as testing and facility design. This will help smaller companies control costs costs that would have been be passed along to the consumer while still maintaining quality standards,” said David Seckman, executive director and CEO of the Natural Products Association. “At 800-plus pages we’ll need to take a longer, more careful look at this document to fully determine its impact on the industry and consumers, but it appears that FDA took some of our concerns into account.”
The regulations establish controls throughout the manufacturing process, including packaging, labeling, and storing, to ensure quality and purity standards are met. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.
“With heightened consumer concern over the safety of food ingredients, particularly those coming from overseas, this new regulation should help to increase consumer confidence in the dietary supplement products they buy,” said Seckman. “Consumers want to be assured that what’s on the label is in the bottle nothing more, nothing less and this regulation aims to make sure that is the case.”
Although released today, the regulation will be officially published in the Federal Register next week. In addition to the final regulation on good manufacturing practices, the agency also issued an “interim final rule” for identity testing that will allow the public and others to comment. Information about both the final GMP regulation and interim final rule can be found on the FDA Web site at http://www.fda.gov/.
After a preliminary review, the Natural Products Association has identified key provisions of the rule. According to the association’s analysis, the final regulation:
Makes GMP compliance the sole responsibility of those domestic and foreign firms who manufacture, label, package or hold dietary supplements in the United States, including those involved with testing, quality control, packaging, labeling and distributing them in the United States. It doesn't place any regulatory requirement on those firms who supply raw dietary ingredients or retailers.
Requires testing the identity of every incoming dietary ingredient. However, firms may petition the FDA for exemption if they have the data to support a system in that offers the same assurance provided by 100-percent identity testing.
Differs from the proposed rule by focusing more on process control versus finished product testing. For example, the rule requires more documentation, including the establishment and use of written procedures or records for certain operations, as well as documentation related to equipment, physical plant sanitation, certain manufacturing operations, quality control, laboratory testing, packaging and labeling, and product complaints.
Allows for the option to use a certificate of analysis (for specifications other than the identity of a dietary ingredient) from a component supplier instead of having manufacturers conduct tests or examinations on the components they receive - provided the manufacturer properly qualifies the vendor and then verifies the accuracy of information on the certificate of analysis.
Differs from the proposed rule in that it allows a more flexible testing scheme for finished products. Testing every component of every batch of finished product is not required. Firms must develop their own “scientifically valid system” for ensuring finished products meet all specifications.
Does not require expiration dating on products, but if one is used, there must be adequate data to support the dating.
Has a staggered three-year phase-in period. The final cGMP rule is effective in June 2008 for large companies (those with more than 500 employees). Companies with less than 500 employees have until June 2009, and companies with less than 20 employees have until June 2010 to comply with the regulations.
Establishes minimum requirements for personnel, physical plant and grounds, and equipment and utensils.
Requires identification and quarantine of returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.
Requires reserve samples of dietary supplements to be held in a manner that protects against contamination and deterioration.
Requires a qualified person to investigate any ‘‘product complaint’’ that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.
For additional information about the final regulation, visit the Natural Products Association’s GMP Notes section on the association’s Web site at www.NaturalProductsAssoc.org/GMPNotes.
Learn More About Final GMPs at Upcoming Education Events
To help prepare industry professionals for the implementation of the final regulation, the Natural Products Association is hosting two GMP-related events via Webinar and onsite seminar. Both programs will provide additional expert analysis and interpretation, allowing ample time for questions from attendees and are offered in addition to the association’s ongoing GMP education program.
Webinar, Friday, June 29, 2007
Final FDA GMPs for Dietary Supplements: Find Out How They Will Affect Your Business
The Web conference, scheduled from 12 noon-2 p.m. EDT, on June 29, will provide early analysis of how the new regulation will affect dietary supplement manufacturers. To register, go to www.NaturalProductsAssoc.org/GMPWebinar.
On-site Seminar, Thursday, July 19,2007, Las Vegas, Nev.
An Advanced Course on the Final GMP Rule for Dietary Supplements
Learn specifics of what the final regulation requires and the consequences of non-compliance. For details and to register, go to www.NaturalProductsAssoc.org/SpecialGMPEvent.
The Natural Products Association, the leader in dietary supplement GMP education since 1999, will also continue to offer additional GMP information and educational programming throughout the year to assist the industry with compliance.