David Lennarz, vice president of Hampton, VA-based Registrar Corp., said increasing number of companies in the food and dietary supplement industries are seeking access to the US market. This creates issues on both sides of the fence, he said. It strains FDA’s resources to control the flow and brings many new players into the market that lack the sophistication to successfully negotiate US import and labeling laws.
Lennarz said that more than 5,000 label violations were detected by FDA import inspectors already in 2014. Border inspections are taking the place of some overseas inspections the agency would like to conduct but lacks the resources to do so.
“FDA doesn’t have the means physically to get out to enough foreign facilities to properly control the import influx, so border inspections are an easier means. We see this in issues relating to adulteration, filth, listeria and e-coli,” Lennarz told NutraIngredients-USA.
“We have grown our service of reviewing ingredients and labels over the last decade because of increased inspections at the ports. There are companies in foreign countries shipping products in from markets where there may be no regulation of their ingredients.”
Inspectors are trained to use the labels as the primary point of information about the contents of containers and the state of compliance of the company shipping the product, Lennarz said. Errors in the labels, even simple ones, can have dire consequences. Labeling errors are one of the biggest reasons imports are refused entry into the U.S. by FDA, he said. FDA has seventy violation codes regarding labeling issues. If a product has one of these label violations, FDA may refuse the product and deem the product “misbranded” under the Food, Drug, and Cosmetic Act, making it a prohibited act to distribute the product in the United States.
Lennarz said FDA can bring a civil or criminal action against a person guilty of committing a prohibited act. Also, once FDA finds one mistake, the agency is more likely to stop the facility’s products at the port of entry in the future. For example, FDA has an import alert specific to nutritional labeling violations. If a product is found to be in violation of certain nutritional labeling regulations, it is noted in FDA’s system. If the same product is found to be in violation again 60 or more days after the initial violation, that product will be added to the import alert and be subject to detention without physical examination (DWPE).
“Some of these companies just load up a container and don’t take the time to review the labels. In Europe, for example, they have a number system for colors. In the US, the name of the color has to be on the label. Something as simple as misidentifying a color can cause an import problem,” Lennarz said.
Registrar Corp. offers a label review service in which companies send in their artwork and a report is generated telling the company how the label must be changed to comply with US laws. Sometimes, that can include advising a company that a product should be reformulated, as in the case of supplement products containing an ingredient that might need to have a New Dietary Ingredient Notification on file.
Lennarz said there is still a significant amount of ignorance among food and dietary supplement companies about the impact of the two FSMA rules that are nearing their final draft. The the two FSMA rules are the Hazard Analysis and Risk-Based Preventive Controls for Human Food and the Foreign Supplier Verification rule.
“When these rules are finalized and get into phase in 2015 and 2016 there will still be a lot of ignorance in the market. A lot of companies operate in countries where they didn’t have to draw up a safety plan that addresses the risks inherent in the food they produce,” Lennarz said.
Consequences of failure
Lennarz said it pays to spend the money upfront to ensure that labels will pass muster. Failure to pass inspection at the border can be time consuming and costly. Firms might have to rebrand on the spot, costing them thousands of dollars to pay a vendor to go into a warehouse, open a container and stick new labels on individual products. Or they might even have to reexport the product to fix a problem, which means their customer will get the shipment late or not at all. But the longest term damage could be to a company’s reputation.
“The other thing to remember is that detentions are public. If I were a buyer for Whole Foods or Walmart or whatever, I might be well advised to avoid doing business with a company that has suffered a detention,” he said.