The FDA's new Good Manufacturing Practices (GMP) legislation is to be implemented between now and 2010, but just exactly how this is to be achieved, especially for smaller companies, is as yet unclear. Large companies (500 employees+) have already undergone the transition; Medium sized companies have until June of the coming year to meet the regulations, while small companies (those with less than 20 employees) have until June of 2010 to bring themselves in line with the new rules.

Thus far however, how the FDA will interpret and put the regulations into practice is a hazy issue, one that is only partially enlightened by the language put forth with initiation of the GMP legislation. So how are small companies to keep up, not only with larger concerns, but with GMP deadlines that are closing in? According to Dr. Vasilios Frankos, director of the agency's Division of Dietary Supplement Programs, help is on the way. At the recent Supply Side West conference in Las Vegas, Dr. Vasilios stated that a compliance guide for small companies will be forthcoming with the new year. A Small Entity Compliance Guide will act to iron out the requirements in plain language, helping to ease the transition of the large group of small business that will be effected by the new standards. We will post updates on the guide as they happen, as well as any other developments concerning GMPs.

For more information about some of the challenges and struggles that small businesses face as the GMPs are put into action, have a listen to this podcast from Nutra Ingredients USA: The biggest challenges in making GMPs work. The Natural Products Association's Daniel Fabricant is among the experts interviewed, and the discussion gives a very clear picture of the challenges and opportunities ahead for the industry.