FDA Regulations

When we pick up a food item, we are usually bombarded with all these claims and facts about the nutrition, provided of course we choose to read the label.  However, the information on something so simple as a Cheerios box can be incredibly overwhelming.

On the front of the box, we see “Nutrition Highlights” and a big red heart with the claim “Can Help Lower Cholesterol*.”  But who gets to determine what gets put into the “Nutrition Highlights” section?  Why is there an asterisk after the claim that it “can help lower cholesterol?”  And that’s just the front of the box.  Turn it over, and you find the intimidating “Nutrition Facts” label.  If you make it down to the ingredients, you can see that there are twelve different ingredients in a box of Honey Nut Cheerios, and that’s not including the “vitamins and minerals” subcategory.  If you include that, there are an additional eleven.  But who decides what can and can go on that box?  If the General Mills got to decide what to put on their cereal box, I doubt they would have chosen to put that asterisk at the end of cholesterol claim.

Fortunately, Rebecca Goldberg, a lawyer who works for the FDA was able to come into our class and clear up a lot of these questions.  While her viewpoints and opinions did not necessarily reflect those of the FDA or the government, she was able to provide the class with valuable information.

The regulation of food is complicated.  First, Congress writes the actual laws, and then the agencies, such as the FDA, enforce the laws through policies and regulations.  In order to introduce the class to some of these policies the class divided into groups and Rebecca Goldberg passed out term cards for us to categorize.These cards all contained different food related phrases, of which some were allowed by the FDA while others were not.  The cards included phrases such as, “Fat-Free Broccoli,” and “Broccoli, A Fat-Free Food.” While “Broccoli, A Fat-Free Food” would be fine to have on a label, “Fat-Free Broccoli” would not be allowed because it is very misleading.  It’s comforting to know that the FDA is concerned with making the labels as non-misleading as possible.  However, this does pose a tremendous challenge as companies have rights too.  Oftentimes, when the FDA tries to ban something, the company will sue on the basis of freedom of speech.  This limits the FDA as they can only really ban something if it is false or inherently misleading.

In order to keep our labels as clear and accurate as possible, there are guidelines that companies must follow when making claims, such as nutrient content claims or health claims.  A nutrient content claim is defined as “[A] claim…made in the label or labeling of [a] food which expressly or by implication characterizes the level of any nutrient which is of the type required by [law] to be in the label or labeling of the food…”  If you found this definition confusing, you wouldn’t be the only one.  Fortunately, Rebecca Goldberg came to the rescue and explained that there is specific language involved in making nutrient content claims which are based on the daily value of a nutrient.  An example of a nutrient claim is, “excellent source of calcium.” Using calcium for example, a product would be an excellent source of calcium, high in calcium, or rich in calcium if it contained 20% or more of the daily value of calcium.  It would be a good source of calcium or considered to contain calcium if it contains 10-19% if the daily value of calcium.  If you look at enough food items, you will probably notice that none of these nutrient claims are used for omega-3 fatty acids (alpha-linolenic acid is pictured below). This is because there is no daily value for omega-3.  There is no daily value as the actual health effects are not yet fully understood.

Another claim you might run into is a health claim.  A health claim is defined as a “claim…made in the label or labeling of [a] food which expressly or by implication characterizes the relationship of any nutrient which is of the type required by [law] to be in the label or labeling of the food to a disease of a health related condition…” Yet again, not the easiest definition to decipher.  Rebecca Goldberg explained that health claims are claim made on a box that related the nutritional contents to diseases or other health related conditions.  Remember that quote on the Cheerios box?   It said “Can help lower cholesterol*.”  The asterisk links the quote to the health claim, “Three grams of soluble fiber daily from whole grain oat foods, like Honey Nut Cheerios cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.  Honey Nut Cheerios cereal provides .75 grams per serving.”  This is a health claim because it relates the fiber in the cereal to heart disease.  Health claims, such as these, must be pre-approved by the FDA.

The regulation of these nutrition and health claims help to provide the consumer with accurate information about their food, but what about drugs?  Naturally, there is another complex definition describing a drug: “The term ‘drug’ means…articles (other than food) intended to affect the structure of any function of the body of man…”  Drug labels can talk about preventing, curing, or mitigating disease.  These claims, though, must be approved by the FDA.  However, since there is so much extra red tape involved in drugs, food companies do not want to have their merchandise classified as a drug.  To avoid being considered a drug, companies will make claims such as “calcium builds strong bones” rather than “calcium helps prevent osteoporosis.” If you claim your product prevents osteoporosis without going through the process of having it tested as a drug, you have just created a non-approved drug.  Of course in order to actually make any of these claims, drug or not, they have to be true. However, the degree of which these claims must be true is somewhat ambiguous.  While the claims cannot be an outright lie, companies do have the right to freedom of speech.  As such, they have a lot of leeway provided the claims are not inherently misleading.  While the companies that make our food and the FDA often clash over what goes into our food labels, it is reassuring to know that the government has agencies in place to ensure the safety and accuracy of our food labels.

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