This is great news for high quality nutritional supplement companies like Univera LifeSciences. Univera has always done extensive biotech testing on their products and compounds:
The U.S. Food and Drug Administration today announced a final rule establishing
regulations to require current good manufacturing practices (cGMP) for dietary
supplements. The rule ensures that dietary supplements are produced in a quality
manner, do not contain contaminants or impurities, and are accurately labeled."This
rule helps to ensure the quality of dietary supplements so that consumers can
be confident that the products they purchase contain what is on the label," said
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition,
as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act,
by the end of the year, industry will be required to report all serious dietary
supplement related adverse events to FDA."The regulations establish the
cGMP needed to ensure quality throughout the manufacturing, packaging, labeling,
and storing of dietary supplements. The final rule includes requirements for
establishing quality control procedures, designing and constructing manufacturing
plants, and testing ingredients and the finished product. It also includes
requirements for recordkeeping and handling consumer product complaints."The final rule will help ensure that dietary supplements are manufactured
with controls that result in a consistent product free of contamination, with
accurate labeling," said Robert E. Brackett, Ph.D., director of FDA’s
Center for Food Safety and Applied Nutrition.Under the final rule, manufacturers
are required to evaluate the identity, purity, strength, and composition of
their dietary supplements. If dietary supplements contain contaminants or do
not contain the dietary ingredient they are represented to contain, FDA would
consider those products to be adulterated or misbranded.The aim of the final
rule is 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.The final rule includes flexible requirements that can
evolve with improvements in scientific methods used for verifying identity,
purity strength, and composition of dietary supplements.As a companion document,
FDA also is issuing an interim final rule that outlines a petition process
for manufacturers to request an exemption to the cGMP requirement for 100 percent
identity testing of specific dietary ingredients used in the processing of
dietary supplements.Under the interim final rule the manufacturer may
be exempted from the dietary ingredient identity testing requirement if it
can provide sufficient documentation that the reduced frequency of testing
requested would still ensure the identity of the dietary ingredient. FDA
is soliciting comment from the public on the interim final rule. There will
be a 90-day comment period, ending on September 24, 2007. Comments may be addressed
to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.The final CGMP and the interim final rule are effective August 24, 2007. To
limit any disruption for dietary supplements produced by small businesses,
the rule has a three-year phase-in for small businesses. Companies with more
than 500 employees have until June 2008 to comply, companies with less than
500 employees have until June 2009 to comply, and companies with fewer than
20 employees have until June 2010 to comply with the regulations.Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html
Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html
To see a consumer article called "Final Rule Promotes Safe Use of Dietary
Supplements," visit http://www.fda.gov/consumer/updates/dietarysupps062207.html.