Get ready for the not-so-kind-and-gentle FDA when it comes to food safety. The agency took abuse from politicians and consumer advocates over its handling of peanut and pistachio contamination earlier this year. Possibly to avoid a third hit, the agency moved swiftly and without warning on May 7 when it sent U.S. marshals into a warehouse of Memphis-based American Mercantile to seize $1.5 million in food ingredients.

The FDA found evidence in March of extensive rodent and insect infestation throughout the company’s warehouse, the agency said in a news release. American Mercantile did not clean up the mess, the agency said, so it obtained a court order to send federal agents to the company’s warehouse. They hauled away food products including sarsaparilla, spearmint leaves, cornstarch, sweet orange peels powder, licorice powder, sassafras and salt.

“FDA will not tolerate a company’s failure to adequately control and prevent filth in its facility,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said in the release. “The FDA is prepared to use whatever legal means are necessary and appropriate to keep potentially contaminated products out of the marketplace.

Tough action matched the words. Functional Ingredients reports that the FDA did not issue a warning letter to American Mercantile before the raid.

The door-kicking has rattled some in the ingredients industry. “If there is anything to be learned from this, it’s that this is a very visible example of a system that needs improvement. Better communication is needed from FDA, third-party certifiers and the National Organic Program and vice-versa,” says Marty Mesh, executive director of Quality Certification Services told Functional Ingredients. QCS was due to re-inspect American Mercantile for organic certification, according to the article.

“The food and supplements industry can expect a lot more of this,” says Loren Israelsen, executive director of the supplements trade group United Natural Products Alliance, told the publication. “This is the new FDA, so wake up everybody.”

Now that the FDA has everyone’s attention, what are the best courses of action?

  • Take health inspections seriously. Ignore an FDA or state agency evaluation and armed men may come through your door.
  • Keep warehouses and manufacturing facilities squeaky clean. Check vendors and demand documentation, not assurances, that they are following certified good manufacturing practices.
  • Communicate. Tell customers, regulators and certification agencies what steps you are taking to make sure that your food ingredients are uncontaminated. Post documents online that show your company and its vendors passed inspections.
  • Trust, but verify, as the Russian saying goes. American Mercantile says on its Web site that its manufacturing plant is GMP/FDA and pharmaceutical compliant, but Functional Ingredient could find no evidence to support those claims.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.