Despite being flagged by the U.S. Food and Drug Administration (FDA) for significant noncompliance with manufacturing regulations, dozens of dietary supplement firms continue to get flagged in subsequent inspections year after year.
According to a sweeping investigation by Natural Products INSIDER, an outlet covering the health and nutrition industry, roughly half of the 63 dietary supplement companies subject to reinspections in 2015 had been previously called out by the FDA for noncompliance with current good manufacturing practices (cGMPs).
First adopted in 2007 and then officially enforced in 2010, cGMPs are regulations that assure identity, strength, quality and purity of drug and supplement products. Some of the regulations are technical, but others are more basic, including maintaining batch production records and confirming the identity of a dietary ingredient.
However, some of the most common violations during inspections are the most basic cGMP requirements.
“On our end, that’s of course concerning that these firms are not bringing the basic aspects of the GMP system in to compliance,” Cara Welch, the FDA’s senior advisor in the Office of Dietary Supplement Programs, told INSIDER. “We’ve cited them. We go back, and they still have the same violations.”
FDA Criticized For Not Taking Action
In spite of the warnings, the FDA has been criticized for not taking firmer and quicker action against noncompliant firms.
To some who follow the industry or counsel dietary supplement firms, it’s unclear why so many firms do not come into compliance.
The firms may not be understanding exactly what they need to do in order to become compliant or may be banking on the fact that due to limited resource allocation by the FDA the agency might not catch them again.
“It seems like what this is showing us is that some of these companies even on reinspection are not understanding what they need to do,” Steve Mister, president and CEO of the Council for Responsible Nutrition in Washington, said to INSIDER. “Are these companies simply putting their heads in the sand, or do they legitimately not understand the requirements under the law? … You have to follow these rules because that’s the only way the government can ensure that what we are putting in the market is safe and beneficial.”
The FDA is also limited in the amount and type of enforcement it can take against a firm. For example, in order for the agency to conduct a mandatory recall, it must determine that the product will cause death or another serious adverse effect. Enforcement also depends on the severity of the violation, the firm’s history with compliance or lack thereof, and its response to violations.
Formulife Spent Years on FDA Radar
In the INSIDER’s latest article on the investigation of cGMPs and dietary supplement firms, the outlet took a thorough look at five supplement manufacturers that received an official action indicated (OAI) designation: Abba Pharma Inc., Formulife, Nature’s Health LLC, Summit Beverage Group LLC and West Coast Labs Inc.
Formulife was inspected by the FDA five times since 2011 with reports of violations in failing to test ingredients, marketing steroids and neglecting to investigate complaints.
The manufacturer of sports supplements was warned by the FDA in two letters that it violated regulations and has been inspected for the last three years in a row. Some of the same violations were observed in several of the inspections.
Finally, in 2015, the OAI designation for Formulife was changed to a voluntary action indicated (VAI) designation, pointing to a small improvement in the status. However, the FDA still describes the VAI designation as “when objectionable conditions or practices were found that do not meet the threshold of regulatory significance.”
In an interview with INSIDER, the director of quality control and regulatory affairs for Formulife asserted the firm is now completely compliant with cGMPS.
Critics of the industry still contend that dietary supplement firms get too many opportunities to come into compliance, but the FDA indicated it may start considering a more serious response to firms that fail inspections year after year.
“I think the time is certainly passing for three or four inspections before we get to shutting down a firm because of violations,” the FDA’s Welch said to INSIDER. “I can’t say we are always going to be moving more quickly to [shut] down a firm or [seize] their products, but I think everyone is becoming more comfortable with the fact that there are certain areas where industry is not getting better, and we need to be serious in our response to those firms.”