What FDA fortification guidance means for manufacturers
More and more companies are trying to balance the nutrient supply in the global food chain and capitalize on the growth of health-conscious consumers. However, the FDA and health experts have concerns about how quickly the fortification movement is expanding and whether fortification is always the right decision.
New FDA fortification guidance
In November, the FDA released new guidance entitled "Questions and Answers on FDA’s Fortification Policy," which "is intended to clarify the existing policy, especially those matters we received questions on, and to remind manufacturers of this policy," Noah Bartolucci, FDA health communications specialist, told Food Dive.
The existing fortification guidelines were published in January 1980 and had since generated questions from the food industry, other federal agencies, academia, and others, Bartolucci said. He said the new guidance "addresses the most commonly asked questions, such as what foods are not appropriate to fortify, what nutrients are covered under fortification, how some nutrient content claims on the label impact fortification policy, or addition of folic acid to foods that are prohibited under our food additive regulations."
Why fortify?
Foods have been fortified for decades, as far back as the early 1900s, when authorities in the South ordered that grits be fortified with niacin to eradicate pellagra, a degenerative brain and skin disease. In 1924, iodine was added to salt in Michigan to help alleviate the impact of goiter, which had spread to 47% of the state. The rest of the country voluntarily followed, and similar fortification efforts spread, such as the fortification of milk with vitamin D in the early 1930s and of bread with niacin, thiamin, riboflavin, and iron in 1943. Fortification of grains with folic acid became mandatory in 1998, per the FDA.
In today’s food industry, many companies have approached fortification by keeping in mind the use of nutrients to battle common diseases through diet.
Companies, such as Kellogg, may "use population research from around the world to determine nutrient needs in different regions" in addition to local regulations, dietary guidance, and considerations about who will eat the product and how much they will eat, Lisa Sanders, director of global nutrition and scientific affairs at Kellogg Co., said in an email.
"Food fortification is a potential PR story for a food brand even if that company doesn't plaster reference to the added mineral or vitamin [on] all of its packaging," Charles Banks, co-founder of the global food trends agency The Food People, told Independent in 2012. "It's the same reason we're seeing a growing number of manufactured food products enhanced with added grams of certain natural ingredients, such as fruit – so a product can be sold as 'providing one of your five a day'."
Is fortification always the best choice for manufacturers?
"Processing destroys nutrients, and the more processing there is, the more destruction you get," Marion Nestle, author and professor of nutrition, food studies and public health at New York University, told The Wall Street Journal in 2009. "Fortification adds back some nutrients, so overall you're better off with a processed fortified food than a processed unfortified one. But a whole food is always going to be superior."
When fortifying foods with additional vitamins and minerals, companies can send mixed messages to consumers if the product contains other ingredients that consumers find unhealthy, such as sugar or sodium.
"Just adding a few vitamins and minerals, we don’t see that as a viable sales approach to try and appeal to someone because they see extra antioxidants or vitamins or something. That’s not typically been our approach," said Dr. Tim Morck, vice president of scientific and regulatory affairs at Nestle.
When fortification has its limits
The FDA feels that "indiscriminate fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply," Bartolucci said. Over- or under-fortification of nutrients can lead to health complications for consumers.
"While consumer research has shown us that most of our consumers view fortification as positive, we also have some consumers who do not desire fortified foods," Sanders said of Kellogg.
The key for manufacturers has been a balance of fortified and non-fortified foods to reach a wider range of consumers. But consumers want foods that are made from fresh, "real" ingredients that inherently contain these nutrients rather than a product fortified with nutrients because it doesn't contain them already.
"The majority of our products are not fortified, and we have such a range of products that a lot of them are based on real foods, our prepared and frozen foods business for example," said Nestle’s Dr. Morck. "We just use regular foods, and we think that providing a balance of foods the way they normally come is an advantage to people in this population."