GMPs on their way, White House tells Senator Hatch

By Clarisse Douaud

- Last updated on GMT

Related tags: Dietary supplement industry, Dietary supplement, Gmps

Senator Orrin Hatch's office received notice that FDA's Good
Manufacturing Practice (GMP) legislation has received final
clearance from the White House Office of Management and Budget,
giving industry the signal to start preparing itself for the
impending changes.

Senator Hatch's office in Washington confirmed for NutraIngredients-USA that Senator Hatch received a phone call from Rob Portman, the head of the White House Office of Management and Budget, Wednesday. Portman informed Senator Hatch, a representative of Utah and frequent advocate for the dietary supplement industry, that the legislation is likely to be published in five weeks. This development represents a ray of light for many parties within the dietary supplement industry, which has been waiting for GMP legislation for twelve years. 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 regarding purity, safety and legality in manufacturing. Republican senator Hatch, one of the principal authors of DHSEA, and Democrat senator Tom Harkin from Iowa have been pushing for the legislation as a means to finalize the Act. However, contrary to reports in the mainstream US media, industry stakeholders insist the dietary supplement industry is in fact already regulated. "Sometimes you hear the mainstream media say this industry is not regulated,"​ David Seckman, executive director and CEO of the Natural Products Association, told NutraIngredients-USA. "They will have to hang that statement with this mainstay regulation." ​ GMP regulation will provide the industry will further tangible evidence against "erroneous"​ accusations, NPA vice president of scientific affairs Daniel Fabricant told NutraIngredients-USA. In the coming weeks, it is not likely that trade associations will be able to answer many of their members' questions on GMPs because they themselves will not see the document until it is released online as part of FDA's (US Food & Drug Administration's) Federal Register. It will subsequently be published in paper form. 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. "Interpretation is the key,"​ said Seckman. 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. "It's hard to tell until you see the final regulation,"​ added Seckman. The FDA draft of GMPs issued to industry for comment in 2003 allowed for a one- to three-year implementation period for manufacturers to comply based on the size of the company. NPA said it already has a lot of the elements in place for helping companies with Good Manufacturing Practices and is plugging the third party GMP certification program it has run since 1999 as a means for companies to ensure they have the appropriate procedures in place. "We think our certification program is a great way for companies to be prepared for this,"​ said Seckman. The industry will also have the opportunity to comment to FDA on GMPs, which will be categorized as an 'interim' final regulation and therefore subject to change. However, any desired modifications could take a long time. Trade associations will be waiting to see what changes have been made to the document since 2003 and to what extent their comments were taken into account. NPA was concerned at the time that the GMPs were not as close to food GMPs as they had hoped and required more stringent finished product testing. The political advocates behind the regulation will also be going over it with a fine-tooth comb. "Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations,"​ said Senator Hatch in a written statement. "Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses." ​ The Council for Responsible Nutrition reported to the media it is planning educational meetings for members and non-members and that an announcement to this effect will be made in the coming weeks. The United Natural Products Alliance has also been asking members to save certain dates for yet-to-be finalized GMP workshops.

Related topics: Regulation

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