In fact, FDA is notably moving forward with enforcement of old and new elements of the Food Safety Modernization Act, which some in the industry speculated incorrectly at the start of the year might be moved to the back burner by the Trump Administration.
For example, just this week the first major compliance date for importers covered by the Foreign Supplier Verification Programs under FSMA went into effect, and according to Claudia Lewis, a lawyer at the Washington, DC, based firm Venable, FDA inspectors are already zeroing in on related requirements.
According to a recent constituent update issued by FDA, the Foreign Supplier Verification Program seeks to ensure that all food consumed in the US meets the same preventive food safety standards regardless of where it was produced. And, as of May 30, all Foreign Supplier Verification Program importers whose foreign suppliers are not subject to the preventive controls or produce safety rules must verify their foreign suppliers meet applicable FDA safety standards.
And even though the deadlines for other covered entities will roll out slowly over the next three years, Lewis said some FDA inspectors are already focusing on the requirements.
“When FDA is inspecting facilities they are focusing on are you getting ingredients abroad? What have you done to ensure you are getting bonafide ingredients? And that they are not contaminated and they are the appropriate types of ingredients to be including in food stuff here in the United States,” said Lewis, adding, “That is a new focus for FDA.”
This is far from the only compliance focal point for FDA. According to Lewis, who regularly reviews warning letters from the agency to industry players to identify areas of concern, FDA also is focused on nutrient content claims and the landmines that the terms “healthy” and “natural” have become.
“The other thing I am seeing in the warning letters … is of course, the claims that are being made for the products,” such as when FDA sent a warning letter to KIND Snacks in March 2015, she said. “We see the agency sort of looking at safety, but also what are you communicating to consumers.”
In the example of KIND, Lewis said that warning letter focused on the use of the term healthy as it relates to nutrient content.
And despite FDA agreeing at KIND’s behest to reevaluate how it defines healthy, ‘this is still an area where the agency is quite active in terms of what types of claims are being made for your product and dare they appropriate under FDA regulations,” Lewis said.
According to Lewis, the KIND warning letter also is illustrative of the type of back and forth industry has with FDA – but not with the plaintiff’s bar. She explained that when KIND pushed back against the agency and petitioned it to update the conditions of use for the term, the agency agreed.
But that didn’t stop plaintiff’s attorneys from moving against KIND and others who use the word healthy and accusing them of misleading consumers.
What is in a name?
Another target for class action false claims suits are fanciful synonyms used to make ingredients sound more appealing or “natural” to consumers, such as the use of evaporated cane juice instead of sugar, said Lewis.
“The class action bar is taking the position that by saying evaporated cane juice, as oppose to sugar, it created a false impression that the product contained less sugar than they actually contained, and we have seen this type of issue and other types of nomenclature used in connection with sugar,” but what it boils down to is if the terms are common and usual names for consumers, Lewis said.
According to Lewis, another emerging area of interest for plaintiff’s attorneys and area of concern for USDA and FTC is organic. This one could surprise some because organic has a clearly defined and enforced set of standards by USDA. But Lewis said it isn’t the standards that are in question, but rather how consumers interpret the term.
“FTC and the USDA had a round table discussion last year in September to talk about organic claims and discuss consumer perceptions in this area,” Lewis said, noting they asked questions such as if consumers perceive organic as something that it doesn’t mean, then does the term need to be further qualified?
FTC remains focused on weight loss, cognition and immunity
Beyond “organic,” Lewis says FTC is sticking with a trilogy of targets in the food and beverage space that it has long taken aim at, including claims related to weight loss, cognition and immunity, according to Lewis.
But, she said, that doesn’t mean companies can never make these claims. Rather, she said, they need to ensure that they have scientific support to back-up their claims in the case of cognition and weight-loss.
Immunity claims, however, are a different debate in that FDA and FTC have cleared defined what is necessary for companies to make these claims, Lewis said.
Ultimately, when it comes to enforcement and trying to avoid running afoul of the laws, Lewis says FDA is not looking for perfection, but rather for companies to have a system of checks and balances, including good manufacturing practices, a food safety modernization plan and consistency in applying the rules to maximize the spirit of the laws.