At long last, industry finally has a GMP rule from the FDA. The 815 page rule "establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement." Over the next several weeks, we'll get ideas and interpretations of what it really means. There are some signs though.

According to the rule, the compliance date is 12 months after publication in the Federal Register, while businesses with fewer than 500 but more than 20 employees will have 24 months, and business of fewer than 20 employees will have 36 months. FDA has also issued an interim rule, separately, regarding an alterative to the required 100-percent identity testing of components that are dietary ingredients.

It is interesting to note that, contrary to the hopes of many, the rule does not cover dietary ingredients, only supplements. Also, the rule squarely places responsibility for assuring ingredient quality with mnaufacturers, meaning that at least in some cases, these players must take a lot more responsibility than has occured in the past.

Does this mean that the development of analytical methods finally takes on the level one priority that it deserves? I hope so. Does this mean that value chain relationships will begin to alter when companies begin to more critically analyze supplier Certificates of Analysis? One can only hope.

When asked about enforcement of the new rule, apparently existing programs and resources, at least at present, are all that will be offered by FDA, suggesting that increased enforcement which would help drive compliance is not an automatic. That is probably quite unfortunate.

And what does the three year phase-in really mean? I certainly understand that smaller companies might need to build some infrastructure and systems for compliance, with larger companies presumably already having a critical mass of activities, and thus taking less time. Practically speaking though, doesn't this really mean that at least three years will pass before any meaningful enforcement, of a company of any size, is even possible? (That's certainly been an observation in Canada where a five-year risk oriented phase in of the regulations has led to essentially limited practical enforcement with so many things in transition and so many moving targets.) I wonder where we'll be in three years.........