FDA Still Finds Basic GMP Violations in Supplement Industry

The manufacturing regulations have been on the books for nine years, but FDA is still finding basic failures, INSIDER learned.

Josh Long, Associate editorial director, Natural Products Insider

March 31, 2016

10 Min Read
FDA Still Finds Basic GMP Violations in Supplement Industry

For a number of years, FDA inspectors have continued to observe dietary supplement firms commit the same egregious violations of manufacturing regulations. Unfortunately, fiscal year 2015 was no different.

Nearly 19 percent of dietary supplement firms that were cited by inspectors for violations of the cGMPs (current good manufacturing practices) allegedly failed to set specifications for the identity, purity, strength and composition of the finished product, INSIDER learned through a Freedom of Information Act (FOIA) request. About 16 percent of firms that were issued a document for violations of cGMPs, or 46 total inspections, failed to verify the identity of a dietary ingredient through an appropriate test or exam, according to the FDA data.

Other common violations of the 9-year-old cGMPs related to batch production records (15.30 percent), written procedures for quality control (QC) operations (13.88 percent) and written master manufacturing records (MMRs, 11.03 percent).

“We’re still seeing observations that are the basics of a GMP system—that is failure to have finished product specs, failure to do identity testing [and failure to have written procedures for quality control]," said Cara Welch, Ph.D., senior advisor to the Office of Dietary Supplement Programs, in a phone interview. “These are serious issues, and the agency is concerned."

FY15 cGMP inspections: 483

Reinspections: 63

Form 483s issued: 281

Total observations: 1,437

Average number of observations: 5.1

Most common observation: failure to establish product specifications

Dietary supplement facilities registered with FDA: 12,964

Source: FDA

Cara Welch, Ph.D.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like