FDA & USDA Related Articles

McDonald's Round Three

It seems like McDonald’s can’t get itself out of trouble, even among its burger-biting faithful. The fast-food goliath has been repeatedly slapped with lawsuits from “former” McDonald’s consumers and angry attorneys general. From people suing because McDonald’s made them fat, to lawsuits generated from previously undisclosed trans fat amounts, to multi-million dollar settlements spawning from cooking-oil mishaps, McDonald’s consistently seems to be bitten by the people who consume their food the most.

While suing McDonald’s may or may not be part of a brand new diet plan for consumers, the chain found itself in even more trouble following the release of FDA’s new labeling requirements. Following the issuance of FDA’s new rules, including one requiring that the presence of common allergens such as milk, eggs, wheat, fish, or peanuts be reported, McDonald’s quietly disclosed on its website that its fries contained “wheat and milk ingredients.”

While McDonald’s is not bound by FDA’s regulations for packaged foods, it chose to disclose these allergens voluntarily. According to the company, it did so even though “technically there are no allergens in there”, but rather “wheat and dairy derivatives”. Even with this move, McDonald’s has been hit by three lawsuits from angry customers, demanding compensation for what they claim to have been false and misleading marketing practices by McDonald’s.

So what does this mean to your company? Well, you may want to consider the following questions: Are you taking legal risks in marketing your products that you don’t even know about? Are you failing to make all of the FDA sanctioned claims about the nutritional or health benefits of your product (note that McDonald’s did not even have to make a disclosure about the presence of wheat and dairy derivatives but were still sued for not doing so earlier)? Are you using or do you want to use marketing techniques that are in a legal gray area? Zackler & Associates specializes in these areas and can help maximize your marketing campaign and keep you and your company safe. From direct advice for the business decisions you make every day, to more general guidance on business best practices, the Z&A team provides the expertise, experience, and energy that will help your business prosper.


The Whole, Grain, Truth

Americans seem to be becoming more and more conscious of their health and are increasingly making food choices based on that concern. Products made with “whole grains” have become more and more popular, bolstered by recent federal guidelines advising consumers to eat three ounces of whole grains every day. Additionally, the FDA recently released guidelines to tell food companies when they should, and shouldn’t, use the term “whole grain” on packages. The guidance document clarifies what the agency considers “whole grain” and what types of claims are appropriate for such products. FDA’s goal is to minimize consumer confusion when choosing food by establishing consistent and reliable information concerning whole grain content.

So what exactly is “whole grain”?

FDA considers “whole grain” to include cereal grains that consist of the intact, ground, cracked, or flaked fruit of the grains whose principal components—the starchy endosperm, germ, bran—are present in the same relative proportions as they exist in the intact grain. Refined grains lose some of their bran and germ in the refining process, which results in a loss of dietary fiber, vitamins, and minerals.

FDA considers whole grains to include the following: amaranth, barley, buckwheat, bulgur, corn (including popcorn), millet, quinoa, rice, rye, oats, sorghum, teff, triticale, wheat, and wild rice. The draft guidance explains that FDA does not consider products derived from legumes (e.g. soybeans), oilseeds (e.g. sunflower seeds) and roots (e.g. arrowroot) to be “whole grains.”

Good, this makes everything easier…right?

Not exactly. FDA has stated that claims characterizing the amount of whole grains in a food, such as “excellent source” or “good source” are not acceptable. Because this type of language typically is used for nutrient content claims, FDA believes that this terminology is not appropriate to imply a certain level of whole grain because such a level has not been defined. Statements of quantity, however, are acceptable. Manufacturers may make factual statements about the percentage (e.g. “100% whole grain”) or the amount (e.g. “10 grams of whole grains”) of whole grains in foods, provided such statements are not false or misleading and do not imply a particular level of whole grain.

Get Involved

The FDA has opened a two month comment period for citizens and industry to weigh in on the new guidelines. So help mold policy by lobbying the FDA – it’s good for industry, and good for your business!


Locking in on "Lean"

A new FDA proposed rule could expand the current rules governing the usage of the word “lean” on food labels. FDA’s current definition of “lean” includes foods such as seafood, game meat products, and meal-type products, but it does not include individual foods such as “mixed dishes not measurable with a cup” like burritos, egg rolls, enchiladas, pizza, quiches, and sandwiches. These products do not meet the weight criterion for main dish foods because they weigh less than six ounces.

For these “mixed dishes not measurable with a cup”, FDA has proposed “lean” be defined as a product that contain less than 8 grams total fat, 3.5 grams or less saturated fat, and less than 80 milligrams cholesterol per reference amount customarily consumed. Although the comment period for FDA’s proposed rule has ended, it is never too early to begin considering how a change in this rule could affect your company.