Advertising & Labeling

IS IT A FOOD, A SUPPLEMENT OR A DRUG?

It’s the Marketing That Counts!

A recent article in The Wall Street Journal discussed how producers of some food products such as cranberry juice, oat meal, walnuts and grass fed beef are taking a page from the pharmaceutical industry and marketing their products directly to doctors to “prescribe” to patients.

This combination of food and medicine brings to mind the fact that the FDA has divided products that can be consumed by the body (orally or intravenously) into three categories: food, dietary supplement and drug. So in 11,708 regulations or less, what’s the difference? What the product contains? How the product is made? How it affects the body? Well, the simplified answer is that in many instances a product’s FDA classification is based on how you advertise it.

If a product is advertised as having a medicinal effect on the body, then it will likely be classified an OTC or a prescription drug. If a product is advertised as affecting the body’s “structure/function,” then it’s likely to be a dietary supplement. If a product is advertised as “good tasting,” “refreshing,” or with other adjectives expressing sensory delight, then it’s likely to be a food. Of course, as far as Mother Nature is concerned, FDA classifications are meaningless. Whether my product XXXX is classified as a food, dietary supplement or as a drug, its physiological effect on the body will be the same.

This simplified analysis leaves out some very significant regulatory distinctions between these classifications such as the fact that (a) the ingredients in food must be GRAS (but not dietary supplements), (b) any products that contain a substance that FDA has classified as a drug must be sold as a drug (c) drugs (but not food or most dietary supplements) need FDA pre-approval before they go to market and (d) both food and dietary supplements can make certain types of FDA approved health claims. Nevertheless, the question of how you will market your product is often as important as what it is.

We often encounter products that are unwittingly being marketed in a manner that is not consistent with FDA restrictions. Zackler & Associates knows all (well almost all) the FDA’s 11,798 regulations and can advise you not only about marketing, but also about product formulation, labeling, nutritional claims, and other issues pertaining to the regulation of your product.

 

FDA Adopts New Trans Fat Labeling

In the most significant change in the nutritional labeling rules since the NLEA rules became effective in 1993, the FDA has mandated that “Nutrition Facts” and “Supplement Facts” panels will have to disclose the amount of trans fatty acids in the product. This declaration is to appear immediately below the declaration for saturated fat. For products having less than 5 grams of trans fat per serving, the amount of trans fat should be rounded off to the nearest 0.5 gram and for products with 5 grams or more of trans fat, the rounding should be to the nearest whole gram. Products that contain less than 0.5 grams of trans fat will not be required to declare trans fat if there are no label claims about fat, fatty acid or cholesterol content. However, the products must state in a footnote that they are not “a significant source” of trans fat. Because trans fat is assumed to have no nutritional value, there will no DRV or DV for it. The new rule will become effective on January 1, 2006.

The new rule also contains a series of conforming amendments that integrate the trans fat declaration into the currently permitted variations of the general nutrient labeling requirements such as the qualifications permitting the use of the simplified labeling format. Also, in order to correct an inadvertent omission in the original FDA regulations, saturated fat will have to be declared whenever any nutrient content claim is made about fatty acids.

Pending further review, the FDA has not approved any on-label nutrient content claims about trans fat such as “trans fat free” nor has the FDA specified any benchmark limits that might be imposed on trans fat containing foods making health claims.

 

Tropicana Agrees to Change Fresh Claim in “Pure Premium Orange Juice” Ad

Tropicana Products, Inc. has agreed to change a television commercial that implied its Pure Premium Orange Juice was the same as fresh squeezed orange juice. Tropicana’s change was prompted by a ruling from the National Advertising Division (“NAD”) criticizing the ad.

The subject ad opened with a woman saying, “I love everything about fresh squeezed orange juice, except the squeezing part - so I pour myself some Tropicana instead.” Tropicana contended that message of the ad was only that Tropicana was a great tasting product and good alternative to squeezing fresh oranges. The competitor challenging the ad before the NAD contended that the commercial implied that Tropicana was identical to fresh squeezed juice. The NAD ruled that text and the images from the commercial would likely confuse consumers into thinking that the Tropicana product was “fresh.” This impression would be false because the pasteurized juice did not meet the FDA’s definition of “fresh” outlined in 21 CFR Section 195.