Impact of FDA-GMP Dietary Supplements Regulations
A Brief History on GMP Regulations
Up until 2007, the United States Food and Drug Administration (FDA) had not fully implemented the powers it was granted under DSHEA. In 2007, the FDA introduced new GMP regulations (Good Manufacturing Practices) which forced all dietary supplement manufacturers to a more level, but higher standard of manufacturing. According to the FDA, these new regulations were enacted so that all supplement manufacturers are using a "consistent and reliable process" to produce unadulterated products that meet label specifications.
The GMP regulations apply to online retailers, manufacturers, online retailers, and wholesalers. They also apply to companies that package, label, or hold dietary supplements. These new regulations have raised the quality standards of the industry and given significant credence to dietary supplements.
How Will The Final Phase-In Of The FDA GMP Regulations In June Impact Your Business?
In summary, the FDA GMP regulations have required supplement manufacturers to document all aspects of manufacturing process; from receipt of raw materials to processing and packaging the product. Specifications need to define the process of identifying and testing of all components and products. Master production records ensure consistent manufacturing of a product and clearly documents its identity, strength, quality and purity. Detailed Standard Operating Procedures and Batch Production Records need to be carefully maintained. In addition, Laboratory Records need to be filed which include written test methods and data for each lot of production. Annual GMP training of key personnel is also mandatory.
The hardest impact of the GMP regulations will be felt by small supplement manufacturers. Raising quality standards involves substantial investment in both equipment and qualified personnel which most small manufacturers are not able to bear. The FDA estimates that it would take $184,000 for small manufacturers to comply with the new regulations. Despite significant sales, many small manufacturers may not be financially able to meet the new GMP regulations. Therefore, it is more than likely that many of these smaller companies will disappear by the end of the year.
Large and medium-sized supplement manufacturers have already been required to be in compliance with the FDA GMP regulations. Many have been weeded out during the process. By June 25, 2010 supplement manufacturers who have 2 to 20 employees will need to be ready for inspection in accordance with the new dietary supplement GMP.
How will these new GMP regulations impact your business? If your supplement manufacturer is not in full compliance with the cGMPs you may have to find yourself a new one very shortly. You should make sure you are in partnership with a contract manufacturer who is thoroughly prepared for the new regulations. If not, consider contracting a new supplement manufacturer for steady business operations.
How Can You Be Sure That You're Selling GMP Dietary Supplements?
Whether you are new to the industry and looking for a supplement manufacturing partner or you need to find a new manufacturer, you should make certain that you partner with a supplement manufacturer who is fully prepared to pass the FDA inspection.
Contract manufacturing should be considered as an extension or internal department of your business. The more comfortable and open your relationship is with your contract dietary supplement manufacturer, the better you can work together for mutual progress and profit. However, choosing the right contract manufacturer who can deliver GMP dietary supplements requires more than gut instincts. Following a few guidelines will ensure that you make the right choice.
- If your prospective manufacturer has been in the industry for a number of years and has held a good reputation, chances are, you are heading in the right direction
- Ask manufacturers about their SOPs, their process for raw material inspection and for final product testing. Product turnaround times are important. Cost-cutting without compromising quality and efficiency are advantages to your business
- Check whether your supplement manufacturer regularly participates in trade shows. If they don't attend trade shows, chances are that they are a very small operation
- Visit blogs and message boards and ask people if they have heard of the manufacturer that you are considering working with. People that regularly contribute to these sites know what manufacturers can be trusted
- Choose a supplement manufacturer who holds your best interests and your valuable customers as their primary focus
- Make sure your supplement manufacturer has well-trained personnel to formulate scientifically-based products and that they follow a stringent manufacturing process that not only meets, but even exceeds the new GMP regulations quality standards
Following these guidelines will ensure you receive GMP compliant supplements. If you have any questions about how NutraScience Labs is meeting the GMP regulations, call (855) 492-7388 to speak with one of our knowledgeable Production Specialists or if you are ready with your product requirements, you may submit a free quote request through our website. The typical turnaround time on any quote request submitted is approximately 48 hours.
About the Author: Andrew Goldman
Andrew Goldman is the Vice President of Marketing for NutraScience Labs. In this role, he leverages his 10+ years of experience to develop cutting-edge initiatives for our firm.