White Plains, New York, March 20, 2020 —
Results obtained by ConsumerLab.com of the FDA's inspections in Fiscal Year 2019 of 598 dietary supplement manufacturing facilities in the U.S. and abroad show that 52% of U.S. facilities and 42% of foreign facilities received letters indicating noncompliance with current Good Manufacturing Practices (cGMPs). Manufacturers are required by law to follow cGMPs. Only a small fraction of facilities are inspected by the FDA each year and, due to the new coronavirus, routine inspections are currently suspended in 2020. The results are for the fiscal year October 1, 2018 through September 30, 2019. ConsumerLab.com received the results by request under the Freedom of Information Act.
The results by manufacturing facility and location
have been posted by ConsumerLab.
There has been modest but steady improvement in GMP compliance rates in recent years. In FY12, 70% of dietary supplement firms inspected received a letter of noncompliance. The figure fell to 65% in FY13, 62% in FY14
, 58.2% in FY15
, and back up to 62% in FY16
-- the last time ConsumerLab requested audit results.
The FDA noted an average of 2.55 infractions and a median of 4 infractions at facilities which received notices. Although specific infractions found at each facility were not disclosed, the most common infractions, each observed at more than 15% of noncompliant facilities, were:
- not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement (25.25%)
- not establishing or following written procedures for quality control operations (21.64%)
- not producing batch records which include the complete information relating to the production and control of each batch (15.08%)
Most of the inspections, 538 out of 598, occurred in the U.S., which is up from 509 in FY16. Among U.S. facilities that were inspected, 52% received citations of noncompliance, although this was an improvement from 61.5% in FY 2015.
Sixty inspections occurred in countries outside the U.S., which is down from 74 in FY16. Among these, 41.7% received noncompliance citations which, overall, is better than in the U.S.
The country with the most inspections after the U.S. was China, where 3 out of 6 (50%) received citations of noncompliance (down from 71.4% in FY16), followed by Germany, where all 4 out of 4 (100%) of inspected facilities received citations of noncompliance. In contrast, none of the 3 facilities in Sweden received citations, while 2 of 3 in Mexico and Taiwan did, and 1 of 3 in Hungary, Japan, and Korea did. Both facilities inspected in Brazil received citations, consistent with Brazil having the worst record in FY15 when all 5 inspected facilities received citations. There were no inspections in India in 2019, in contrast to FY16 when 9 of 11 facilities, or 81.8%, received citations.
"Although an improvement over past years, the most recent FDA audits show that, overall, dietary supplement manufacturers need to do a lot better," commented Tod Cooperman, M.D., the founder and president of ConsumerLab, which has been testing and reporting the quality of dietary supplements in the U.S. since 1999. Dr. Cooperman added, "Consumers often express concern about supplement ingredients from China, but the U.S. is doing no better than China based on this limited sampling." Overall, ConsumerLab finds that about one in five supplements in the U.S. and Canada that it tests in its product reviews
do not meet quality parameters. Its testing tends to focus on more popular and established brands, guided by an annual survey
of its readers' interests.
The Form FDA 483 letters do not represent the FDA's final determination regarding compliance. Companies may respond to the observations in the letters. If responses are insufficient, the FDA may issue a Warning Letter. ConsumerLab.com regularly posts these Warning Letters on the Recalls and Warnings page
and in its free newsletter
Founded in 1999, ConsumerLab.com
is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. Membership to ConsumerLab.com is available online
and provides immediate access to continually updated reviews of nearly every popular type of dietary supplement and health food, answers to reader questions, and product recalls and warnings. ConsumerLab also provides independent product testing through its voluntary Quality Certification Program
. The company is privately held and based in New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.
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