On June 22, 2007, the Food and Drug Administration (FDA) released long awaited current Dietary Supplement Good Manufacturing Practice (cGMP) regulations. Reaction from the supplement industry in general has been very positive, with trade associations such as the Council for Responsible Nutrition (CRN), American Herbal Products Association (AHPA) and the United Natural Products Association UNPA) welcoming regulations they requested and provided guidance on.
Some other interested parties in the media have provided stories with titles ranging from;
- FDA phasing in rules for dietary supplements
- FDA Publishes Final Rule on GMP Requirements for Dietary Supplements
- FDA Plans to Rein in Supplement Industry – Just a Bit
- FDA Rule Still Won’t Ensure that Dietary Supplements Are Safe
AdvoCare has always provided safe, effective, high quality dietary supplements to our consumers and we support the FDA’s efforts to ensure that all supplement manufacturers consistently meet quality goals such as ours. The codification of these regulations going beyond even those we are in compliance with currently should also aid in clarifying to the media and public in general that the dietary supplement industry was and remains a regulated field.
The concepts behind these regulations were proposed by the FDA in 1997 and in 2003 proposed regulations were published which generated over 400 written responses. The recently released final version of the regulations incorporates comments and suggestions made by industry and the public in 2003.
The advance release version of these critical regulations is 815 pages long and this document is currently under review by AdvoCare personnel. AdvoCare staff members have monitored the progress of the proposed regulations as they went through a complicated and time consuming period of industry and intra-agency review and revision until they reached this initial publication stage.
These regulations are intended to ensure that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and that they are accurately labeled. In order for a manufacturer to fully comply with these regulations, systems must be in place to establish quality control specifications and procedures, manufacturing and storage control, testing of finished products and management of consumer complaints. Safe and effective high quality products have always been a cornerstone of the AdvoCare philosophy and the new regulations will only underscore our continuing efforts to assure that we remain on the forefront of the dietary supplement marketplace.
AdvoCare and our highly qualified manufacturers remain vigilant in our quest to provide the best and most effective products available.We believe in high quality, safe and reliable products because it is the right thing for the consumer and the new cGMP’s add an edge to keep us sharp. The deadline for adoption of and full compliance with these new cGMP’s for AdvoCare as currently proposed is 2009. For additional information we also have a FAQ (remember those?) posted on our website.