After 13 years of negotiations and false dawns between industry stakeholders, regulators and consumer groups, the US finally has a set of Good Manufacturing Practices to govern dietary supplements.
Industry welcomed the 800+ pages regulation which, coupled with the recently passed Adverse Event Reporting legislation, will ensure supplements production meets established standards and should save $40 million per year in reduced product recalls and medical bills.
Until the GMPs called for under the 1994 Dietary Supplements and Health Education Act were established, inconsistent supplements quality drew criticism that deflated consumer confidence and tarred the whole industry.
"With heightened consumer concern over the safety of food ingredients, particularly those coming from overseas, this new regulation should help to increase consumer confidence in the dietary supplement products they buy," said David Seckman, executive director and CEO of the Natural Products Association. "Consumers want to be assured that what's on the label is in the bottle nothing more, nothing less and this regulation aims to make sure that is the case."
Steve Mister, president and CEO of Washington DC-based Council for Responsible Nutrition welcomed the new GMPs as "a step forward for our industry" while noting: "I'm sure we won't agree with everything in the rule but it's our job now to thoroughly review the rule and work with companies to explain these standards and to ensure its details are understood and complied with fully. We look forward to partnering with FDA on this education process."
The Food and Drug Administration said the regulation was designed to "prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling."
Small and medium-sized businesses will have three and two years respectively to meet the requirements — a concession granted due to the cost of GMP implementation which the FDA expects to cost companies $164 million per year from 2010. Despite these concessions, the FDA stated GMPs would have a "significant economic impact" on smaller businesses. Companies with more than 1000 employees have 12 months to comply.
Mark Blumenthal, founder and executive director of Texas-based American Botanical Council noted the regulation would have a minimal effect on responsible supplements manufacturers as they already had high manufacturing standards in place.
A somewhat contentious exemption from "100 per cent identity testing" is written into the document where it can be shown "that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient." While some see this as a potential loophole, Michael McGuffin of the American Herbal Products Association said the regulation contained checks to stop this cost-saving clause from being exploited.
Supplements imported into the US will also have to meet the GMPs, leading some to question whether supplements stemming from markets like China and India would stand up to scrutiny.
The ruling applies only to dietary supplements manufacturers. Retailers and ingredients suppliers are exempted.
The ruling can be found at: http://www.fda.gov/ohrms/dockets/98fr/cf0441.pdf.