Neal D. Fortin

Food Regulation


Скачать книгу

complete milking of one or more healthy cows… .”65 While the definition is clear that plant‐based products are not “milk,” the issue of qualified names, such as “soymilk,” remains unresolved. Since the 1980 Central Hudson decision, the government needs a substantial interest to restrict commercial speech, and the restriction cannot be more extensive than necessary.66 A complete ban on use of the term “milk” on plant‐based alternatives is likely to be seen as more restrictive than necessary to advance the government’s interest. In short, it is doubtful the FDA has the authority to restrict terms like “soymilk” unless the use is false or misleading.

      Nonetheless, debate continues over whether soymilk and similar products fail to disclose material facts about their comparative nutritional composition. However, such comparisons are complicated. Cow’s milk is an excellent source of protein, calcium, vitamin A, and vitamin D. On the other hand, soymilk contains more fiber than cow’s milk and reduces cholesterol instead of increasing it. Moreover, the Nutrition Facts provide consumers comparison information.

      You Say Meat, I Say ‘Schmeat

      Similar debate lines have drawn up over the naming of meat substitutes. Should cell‐cultured meat be allowed to be called “meat”? Should plant‐based patties be allowed to use the word “burger”? The U.S. Cattlemen’s Association filed a petition with FSIS requesting the agency officially limit the labeling of “beef” to “cattle born, raised, and harvested in the traditional manner, and that products that are labeled as meat” should be limited to those that are derived from the tissue or flesh of an animal harvested in the traditional manner. A number of states have passed laws prohibiting use of meat descriptions or terms on plant‐based or cell‐cultured products.

      FD&C Act section 403(d) states that a food is misbranded “if its container is so made, formed, or filled as to be misleading.” FDA has rarely taken enforcement action against misleading packaging under this section.

      As the following case illustrates, courts have been reluctant to find violations of this provision. Part of the reason some courts have been reluctant to find deceptive packaging is because the net contents of the package is declared on the label. In addition, a certain level of slack filling is required for machine filling. Because the packages clearly do not have to be packed tightly, courts have been reluctant to find that packages should have been packed tighter.

      In the following case, the court additionally held that deceptive packaging may be allowable if necessary for protection of the product from the condition handling and shipping. Therefore, to prevail, FDA would have to demonstrate not only misleading fill, but that the amount of slack fill (or padding) was unnecessary for protection of the contents or that nonmisleading yet protective alternative packaging was available.

       United States v. 174 Cases Delson Thin Mints

       287 F.2d 246 (1961)

      Before BIGGS, Chief Judge, and GOODRICH and FORMAN, Circuit Judges.

      Opinion by: BIGGS.

      Under Section 403(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 343(d), food must be held to be misbranded “if its container is so made, formed, or filled as to be misleading.” The standard set up by Judge Wyzanski is “whether the container would be likely to mislead the ordinary purchaser of this type of merchandise … “We think this standard is the correct one”.

      The opinion of the court below … sums up the evidence of the United States that the containers were so slack‐filled as to be misleading and that their structure rendered them no more effective but perhaps less effective in safeguarding their contents than less misleading forms and also the claimant’s evidence that its containers were a more efficacious safeguard for its product than other less deceptive containers would have been.

      There are two ways in which a trial court may hold for the claimant in cases such as that at bar. First, the court can find as a fact that the accused package is not made, formed, or filled in such a way that it would deceive the ordinary purchaser as to the quantity of its contents. Alternatively, the court may find as a fact that even though the form or filling of the package deceives the ordinary purchaser into thinking that it contains more food than it actually does, the form and filling of the package is justified by considerations of safety and is reasonable in the light of available alternative safety features.

      Did the district court in the present case make either of these findings? We conclude that it did not do so.

      First, the court below did not find that the Delson package did not deceive the ordinary purchaser by making him think that it contained more than it actually did contain. The court stated in respect to this issue: “The case is, in my opinion, lacking in adequate proof that the average adult, of normal intelligence, would be induced by the exterior appearance of the accused containers to buy a box of Delson mints with the expectation that it would contain any particular number of individual candies.” This statement is beside the point. The question was not whether the ordinary purchaser would expect to find a particular number of individual candies in the box but whether such a purchaser would expect to find more of the Delson box filled. For example, the purchaser of a crate of apples opens the crate and finds it half filled. To determine whether he was deceived we do not ask whether he expected to find a particular number of individual apples in the crate. We do ask whether he expected to find more of the crate filled. This is the pertinent question. People do not think in terms of the number of individual mints when buying them in containers.

      As