After years of debate and delay, the US Food and Drug Administration finally issued regulations in June that establish current
good manufacturing practices (GMPs) for dietary supplements. These rules have been in the works for more than a decade, a
period that has witnessed substantial growth in the $20-billion market for vitamins, minerals, herbal products, sports supplements,
and other supposedly health-enhancing products. It probably is not just a coincidence that FDA finally received clearance
to issue these rules in the wake of mounting concerns over contaminated ingredients from China and other regions of the world
increasingly found in foods, animal feeds, and health and beauty products sold to US consumers.
The FDA rules, which were authorized by the Dietary Supplement Health and Education Act (DSHEA) of 1994, apply to all domestic
and foreign companies that manufacture, package, and label supplements for sale in the United States. The rules clarify that
the final supplement producer is responsible for ensuring that all substances and ingredients in these products meet GMP standards
for quality, purity, identity, strength, and composition. The "burden is on the manufacturer" to use the most scientifically
defensible method available to determine quality, commented Robert Brackett, director of FDA's Center for Food Safety and
Applied Nutrition (CFSAN), in announcing the new regulation.
The lengthy rule (available at
http://www.fda.gov/) sets standards for designing and constructing manufacturing facilities to prevent product contamination and adulteration
and requires quality-control procedures to ensure a consistent and reliable production process. A key requirement is for manufacturers
to test the identity of all ingredients to ensure that supplements meet quality specifications and contain what the manufacturer
intends. To avoid redundant testing, however, the final policy permits manufacturers to obtain certificates of analysis from
component suppliers that an ingredient meets certain set specifications. This policy allows manufacturers that have established
relationships with suppliers to avoid extensive testing for all incoming products, explains Andrew Shao, vice-president of
the Council for Responsible Nutrition (CRN). Final manufacturers, though, must qualify those suppliers. The supplement maker
also remains responsible for identity testing and is expected to periodically confirm test results by other parties. The GMPs
also require detailed recordkeeping and systems for handling and recording consumer complaints. They clarify what information
on product quality and appropriate use should be on product labels.
Supplements that fail to meet these requirements would likely be adulterated or misbranded. Minor violations may prompt FDA
to require labeling changes or product recalls; more serious infractions could lead to product seizures and even criminal
In Washington This Month
While the GMPs set many new requirements for manufacturers, FDA emphasizes that it has taken steps to address industry concerns.
The agency intentionally does not specify what kind of testing or procedures companies should follow to ensure product quality,
but leaves it to manufacturers to use valid testing procedures able to show that products meet specifications and are not
adulterated. And instead of requiring manufacturers to have a "dedicated quality-control unit," the final rule calls for companies
to have "quality-control personnel" responsible for this program. This provides leeway for such staffers to perform other
functions, an approach important for small companies.
Another accommodation for small firms is to phase in the new policies over three years. While larger companies (those with
more than 500 employees) must comply with the regulations by June 2008, smaller firms have another year to meet the new policies,
and very small companies (those with fewer than 20 employees) have until June 2010 to comply.
FDA also is proposing a new petition process for companies to seek exemption from the requirement for 100% identity testing
for all supplement ingredients. In a companion interim final rule, the agency outlines a system for manufacturers to request
exemptions by documenting that the company can still ensure product identity even with less frequent testing. FDA is soliciting
comments on this proposal through late September and hopes to move forward quickly to implement a petition process.