Earlier this month (March 3, 2010), U.S. Food & Drug Administration Commissioner Margaret Hamburg issued a Press Release announcing a major and broad initiative to increase FDA enforcement against illegal claims on food labeling, including unauthorized Nutrient Content Claims, health claims, and all drug and disease claims. FDA is also committed anew to cracking down on technical violations on both the Front of Package labeling and on Nutrition Facts Panels. FDAImports.com, LLC, a US-based FDA consulting practice owned by Benjamin England, a 17 year FDA veteran with over 20 years of practical FDA labeling compliance experience, believes that this is the beginning of a major effort to stop imported foods, imported beverages, and imported dietary supplements in their tracks before they are able to reach US consumers. “The easiest violation for FDA to find is a labeling violation,” says England at FDAImports.com. “FDA does not have to test the product to find the problem. The inspector just looks at the label,” he continued. Food labeling, beverage labeling and dietary supplement labeling requirements can be highly technical, as several dozen domestic and foreign food and beverage manufacturers learned this month.
FDA recently issued more than 15 “Warning Letters” to major food and beverage manufacturers on February 22, 2010 and an additional, such as Dreyers Grand Ice Cream, Inc., Gorton’s, Inc., Schwan’s Consumer Brands, Beech-nut, Spectrum Organic Products, Inc., Nestle, Inc., Sunsweet Growers, POM Wonderful, Pompeiian, Inc., and Diamond Food, Inc.
FDA seems particularly focused upon food labels that bear false or misleading claims about fat content in foods, which are a type of nutrient content claims. These content claims dominated FDA’s warning letters, including allegations that well known food and beverage makers and distributors were improperly using words such as “light”, "cholesterol free," "plus” and "good source” in food labels without meeting the strict regulatory criteria that apply to such claims. In a bit more nuanced move, FDA attacked “antioxidant” claims for food ingredients and nutrients. FDA’s position is that an “antioxidant” claim amounts to an implied nutrient content claim. Apparently the agency is prepared to back up its position by threatening enforcement action. FDA clearly believes the consumer is influenced by nutrient content claims on food and beverage labels, which is good for food and beverage companies. But, in FDA’s view, with influence comes responsibility.
The agency is also taking issue with improper or missing percentage juice claims, which leave the consumer with a false impression that a juice blend with added flavor is a 100% juice. Not unsurprisingly, FDA found illegal and fraudulent disease and drug claims on a number of food labels and labeling (including product labels and product websites). What might be more surprising is FDA finding these claims in places industry is not used to FDA looking – advertising and internet marketing materials.
Bad Food Claims Bring FDA Import Alerts and Warning Letters
FDA is clearly taking a strict enforcement position with respect to food labels, beverage labels and dietary supplement labels. US law and FDA regulations limit the types of claims which may appear on the labeling of most foods and drinks. The rules also impose complex and specific technical requirements on whether and how nutrient content claims and health claims may be made. Drug (disease) claims which purport a food can treat, prevent, or cure a disease are strictly prohibited on all food labeling (except some medical foods, which have their own unique legal category).
When FDA finds illegal food label claims or nutrition labeling violations on imported foods, FDA may (or may not) give the foreign manufacturer warning before placing the food or the foreign manufacturer on FDA Import Alert. Being placed on an Import Alert creates a significant trade barrier for foreign food, beverage, and dietary supplement manufacturers and exporters. “The worse part of this story is that FDA Warning Letters and FDA Import Alerts for labeling violations can all be avoided by getting the labeling right,” says England of FDAImports.com. England concluded, “With increased focus on nutrition in the US, there comes an increase in FDA enforcement against bad, false or improper label claims and nutrition labeling. It’s the sign of the times, at least during the present governmental cycle. Imported food is just a big fat target because it all has to go through the Customs and FDA bottleneck at the border. As FDA increases its border inspection capacity, the number of FDA detentions and refusals (and import alerts) related to labeling errors is sky rocketing.” England and FDAImports.com represents many foreign food, beverage and dietary supplement manufacturers and marketers as well as US importers who are confronted with FDA and Customs problems.