WASHINGTON, D.C., February 28, 2012—Recent comments by Food and Drug Administration (FDA) officials highlight the risks to supplement manufacturers who don’t fully implement the current Good Manufacturing Practices (cGMP) regulations, while underscoring the fact that many dietary supplement companies that have been inspected are not fully compliant. FDA’s remarks, made during a webinar hosted by the Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, should prompt companies to take advantage of the resources available to help them understand and implement the cGMPs in their own facilities.
During the webinar, senior officials from FDA—Daniel Fabricant, Ph.D., director, Division of Dietary Supplement Programs (DDSP), Center for Food Safety and Applied Nutrition, (CFSAN); Brad Williams, GMP team leader, DDSP, CFSAN; Carl Reynolds, senior consultant to DDSP; and Angela Pope, consumer safety officer, GMP Team, DDSP, CFSAN—advised companies can improve their chances for a successful inspection by focusing on key areas like:
- developing detailed master manufacturing records;
- making sure that everything is documented. FDA repeated its often-heard mantra that “if it isn’t written down, it didn’t happen.”
- testing incoming ingredients as well as finished products for identity, strength, purity and composition;
- establishing specifications, verifying that specifications have been met, and documenting everything including any corrective actions taken;
- preparing accurate batch records;
The FDA speakers raised concerns about the variety inspection issues FDA officials have encountered in their early inspections under the dietary supplement GMP regulations.
“FDA’s remarks are a wake-up call to the industry,” said Steve Mister, president & CEO, CRN. “We have a responsibility to comply with the regulations, and failing to do so will negatively impact consumer confidence in our products as well as triggering follow-up action by FDA. Fortunately, there are a number of resources available to companies to help them prepare for their first inspections.”
Additional GMP compliance resources include a large number of law firms, consultants and other businesses that specialize in helping companies understand the GMP regulations or providing legal advice concerning supplement regulation. Many CRN members are among the many companies who provide these kinds of services to industry. For example, two additional speakers on the webinar, Nicki Jacobs, president, Jacobs Compliance Services and Joy Joseph, president and founder, Joys Quality Management Systems, regularly provide GMP consulting to supplement manufacturers. Other CRN members who are able to provide these services include:
- Aegis Sciences Corporation
- Amin Talati, LLC
- Burdock Group
- Covance Laboratories, Inc.
- dicentra Inc.
- EAS Consulting Group, LLC
- Greenberg Traurig, LLC
- Kelley Drye & Warren LLP
- KGK Synergize Inc.
- NSF International
- Patton Boggs LLP
- SafetyCall International
- Sawaya Segalas & Co., LLC
- UL-STR
- U.S. Pharmacopeia
- Venable LLP
Another resource available to companies is a new book—Dietary Supplement Good Manufacturing Practices: Preparing for Compliance—by William J. Mead. CRN’s former president and current industry consultant, Annette Dickinson, Ph.D., wrote the forward to the book, while current president & CEO Steve Mister provided a short review, writing that “Bill Mead’s primershould be required reading for every quality control department in the supplement industry.”
“With so many resources available in this area, I hope that companies will take advantage of them in order to meet their obligations for GMPs,” said Mr. Mister. “Being prepared when FDA knocks on the door will remove a lot of the anxiety from the process.”
CRN’s most recent GMP webinar was held on January 18 and was co-hosted by VIRGO. It is currently available for purchase on-demand and will continue to be available until April 23. To learn more about the webinar or to purchase it on-demand, please visit Natural Products Insider or contact Trainor Walsh at twalsh@crnusa.org. To learn how to reach a consultant mentioned above please visit www.crnusa.org. To purchase Dietary Supplement Good Manufacturing Practices: Preparing for Compliance, please visit Amazon.com.