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Mark A. LeDoux, Chairman and CEO of Natural Alternatives International, Inc. and Chair of The Council for Responsible Nutrition spoke next at the American Conference Institute conference on dietary supplements, nutraceuticals and functional foods on the issue of new GMP rules for dietary supplements.

Helpful links from the presentation include FDA’s PowerPoint presentation the proposed regulations here: http://www.cfsan.fda.gov/~lrd/fr030313.html and a side-by-side comparison between the proposed dietary supplement GMP’s and the food GMP’s here: http://www.cfsan.fda.gov/~dms/dscgmps3.html. Also, more information courtesy of CRN is here: http://www.crnusa.org/pdfs/GMP4way.pdf.

Moderator Lambert observed that GMP implementation will probably result in “trial runs” by FDA inspectors of large facilities to allow FDA to become comfortable with the new regulations and their application.

LeDoux emphasized that GMP implementation will impact foreign supplement and ingredient manufacturers because the regulations will will apply to foreign firms that produce products imported into the US. The new GMP regulations may also be copied by some foreign governments, including ones in Asia, looking to create their own standards. LeDoux also observed that GMP implementation will also allow US firms to operate on an even playing field with foreign firms in countries that already have GMP regulations in place.

On a side note, one attendee noted that the implementation of GMP regulations may prompt plaintiffs lawyers in products liability cases to use the GMP’s as a standard of care for manufacturers in personal injury litigation. Good point.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.