The countdown to preparations became more imminent just over two weeks ago, when Senator Hatch received word the legislation would likely be published in five weeks time. Rob Portman, the head of the White House Office of Management and Budget informed Utah's Senator Hatch, an advocate for the dietary supplement industry, that the legislation will likely be published in five weeks.
After a twelve year incubus period, upcoming GMP legislation presents both business opportunities as well as new responsibilities to third party contractors, manufacturers, trade associations and certification specialists.
NSF's "One Step Ahead" program is designed to help manufacturers prepare for the upcoming GMPs by means of a web-based service center for companies to enroll in as part of the NSF GMP program.
"Although the final regulations are in development, we believe that now is the time for NSF to offer the industry a one-stop resource on GMP services so that they can stay one step ahead as these new regulations are promulgated," said David Abney, general manager of NSF's Dietary Supplements and Functional Foods Certification Program. .
A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been referred to as the missing link in the overall governance of the dietary supplement industry. The legislation will provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing.
The new legislation will create new business opportunities for companies or organizations that can support manufacturers looking to upgrade or comply with GMPs within the time frame to be specified.
"Ultimately, we believe this means establishing a long-term relationship with manufacturers to help them improve the quality of dietary supplements from production to inspection to the market," said Abney.
NSF is presenting its program as a means of enhancing the creditability of manufacturing through certification.
"This experience combined with NSF's technical expertise in providing GMP facility audits and registration services will keep manufacturers at the forefront of regulatory requirements, ensuring they are GMP compliant," said Abney.
Enrolling in the online portion of NSF's GMP certification program allows companies to be kept up to date on FDA developments.
As part of the organization's program, auditors evaluate production facilities for GMP compliance. NSF will subsequently conduct two audits per year to ensure continued conformance.
GMP regulation will provide the industry will further tangible evidence against accusations, NPA vice president of scientific affairs Daniel Fabricant told NutraIngredients-USA.
The GMPs will be released online as part of FDA's (US Food & Drug Administration's) Federal Register and subsequently published in paper form. The document has been completely confidential and the exact date of release is not publicly known.
Industry organizations and companies alike will then have their work cut out for them as the document is set to be approximately 1300 pages in length.
Trade organizations will then finalize educational sessions or workshops to inform industry on how to comply with the regulations, which will depend on how the final draft of GMPs has turns out.
