An Opportunity to Seize

At the request of FDA (Rockville, MD), U.S. marshals last month seized more than $1.5 million worth of food products, including herbs and botanicals, stored under unacceptable conditions at American Mercantile Corp. (Memphis).

During an inspection of American Mercantile in March, FDA investigators discovered evidence of extensive rodent and insect infestation throughout the company's warehouse. The company failed to correct these problems by May. Acting on a warrant issued by the United Stated District Court in Memphis, U.S. marshals seized all FDA-regulated food products exposed to rodent and insect contamination at the facility. The seized products violated the Federal Food, Drug, and Cosmetic Act because they were held under unsanitary conditions.

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

American Mercantile stores and processes food ingredients, which are then sold to the dietary supplement and herbal tea industries. The seized articles included food products, such as sarsaparilla, spearmint leaves, corn starch, sweet orange peels powder, licorice powder, sassafras, and salt.

Food safety problems with peanuts and peppers have pushed the agency into stronger enforcement action. "The food and supplements industry can expect a lot more of this," said Loren Israelsen, executive director of United Natural Products Alliance (UNPA; Salt Lake City). "This is the new FDA, so wake up everybody," he said. Israelsen said FDA now has the 3 M's in its hands-"money, mandate, and manpower."

Israelsen expects FDA enforcement to speed up by July. Now that companies have been inspected for the first time, FDA has a benchmark for comparison. "It's like letting the ECG machine run for 90 seconds before measuring the health of one's heartbeat," Israelsen said. "FDA needs a baseline."

The raid definitely raises questions about compliance issues. American Mercantile's Web site cited the company as being certified organic and "GMP, FDA, and pharmaceutical compliant." The company is now due for renewal for organic certification with Florida-based Quality Certification Services (QCS; Gainesville, FL).

"If there is anything to be learned from this [experience], 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," said Marty Mesh, executive director of QCS.

Mesh said that had he been informed about this situation from FDA in March, his organization could have taken action with unannounced inspections to verify or resolve any unsanitary conditions at American Mercantile.

Given American Mercantile's vertical integration with a finished food company, the question still lingers about whether the contamination affected finished foods. For example, Ingredients Corp. (Memphis) distributes branded and private-label spice blends under American Mercantile's brand, and sells the Barzi brand dried-bean soup mixes to 80 countries.

"Certainly the relationship between the companies raises some red flags," said Daniel Fabricant, PhD, vice president of scientific and regulatory affairs at Natural Products Association (Washington, DC). He noted that any time a regulatory system looks only at "snapshot history," such as the current system, myriad situations and questions will arise.

"Inspectors are only at the facility for one week of the year," he continued. "We must have standards and enforceable procedures in place for the other 51 weeks of the year. That is the standard that the industry must work towards."