Food Regulation. Neal D. Fortin

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СКАЧАТЬ result in its becoming a component or otherwise affecting the characteristics of any food. Paper food‐packaging when containing polychlorinated biphenyls (PCBs), for example, is an adulterated food because the PCBs may migrate from the package to the food and thereby become a component of it. Yet the statutory definition of “food” also includes in Section 321(f)(1) the common‐sense definition of food. When the statute defines “food” as “articles used for food,” it means that the statutory definition of “food” includes articles used by people in the ordinary way most people use food—primarily for taste, aroma, or nutritive value. To hold as did the district court that articles used as food are articles used solely for taste, aroma or nutritive value is unduly restrictive since some products such as coffee or prune juice are undoubtedly food but may be consumed on occasion for reasons other than taste, aroma, or nutritive value….

This double use of the word “food” in Section 321(f) makes it difficult to interpret the parenthetical “other than food” exclusion in the Section 321(g)(1)(C) drug definition. As shown by that exclusion, Congress obviously meant a drug to be something “other than food,” but was it referring to “food” as a term of art in the statutory sense or to foods in their ordinary meaning? Because all such foods are “intended to affect the structure or any function of the body of man or other animals” and would thus come within the part C drug definition, presumably Congress meant to exclude common‐sense foods. Fortunately, it is not necessary to decide this question here because starch blockers are not food in either sense. The tablets and pills at issue are not consumed primarily for taste, aroma, or nutritive value under Section 321(f)(1); in fact, as noted earlier, they are taken for their ability to block the digestion of food and aid in weight loss. In addition, starch blockers are not chewing gum under Section 321(f)(2) and are not components of food under Section 321(f)(3). To qualify as a drug under Section 321(g)(1)(C), the articles must not only be articles “other than food,” but must also be “intended to affect the structure or any function of the body of man or other animals.” Starch blockers indisputably satisfy this requirement for they are intended to affect digestion in the people who take them. Therefore, starch blockers are drugs under Section 321(g)(1)(C) of the Food, Drug, and Cosmetic Act.

      Affirmed.

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2.3 THE CENTRAL ROLE OF INTENDED USE

      In the Nutrilab starch blockers case, the manufacturer’s intent was clear. As was the fact that the product was not consumed for its taste, aroma, or nutritive value. Thus, starch blockers were deemed other than a conventional food.

      The Nutrilab case provides one of the best rules for determining whether a product is a food or a drug. First ask, is the product a common‐sense food? If not, is it consumed primarily for taste, aroma, or nutrition? If the answer is no to both these questions, then the product may not be a food. There can be other factors, but this common‐sense rule still provides excellent guidance.

      Other products, however, might not present such clear distinctions. This subject is discussed in more depth in future chapters, but it is important to understand that the intended use of a product may determine whether it is a conventional food, a dietary supplement, or a drug. A generation ago, any health claim for a food or supplement moved the regulation of the product to “drug” status. Food–drug distinctions are less clear today because health claims no longer automatically move a food or dietary supplement over to regulation as a drug. FDA‐approved health claims are permitted, for instance, without triggering drug status. In addition, structure–function claims are a category of health‐related claims that are not regulated as health claims (for example, “calcium helps build strong bones”).

Foods can make structure–function claims without automatically being regulated as drugs. On the other hand, non‐food products that bear a structure–function claim fall into the drug category.⁹ This is why the food/non‐food determination is pivotal when examining structure–function claims on products.

      The law is straightforward on simple claims. This organization becomes murky at times because it can be difficult to draw distinctions between structure–function claims that may imply a drug claim. Chapter 5 returns to this topic in detail. For now, just be sure to understand two straightforward ways a product may be regulated as a drug, subparagraphs (B) and (C), in the drug definition:

       Non‐food that is intended to affect the structure or any function of the body.

       Intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

      2.3.1 Products Ordinarily Considered Foods

      A claim indicating an intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease is a drug claim. There have been a number of cases where products—ordinarily considered foods—were classified as drugs because of the product’s therapeutic claims:

       Honey¹⁰

       Vinegar and honey¹¹

       Tea¹²

       Water¹³

       Blue‐green algae¹⁴

       Mussels¹⁵

      2.3.2 Evidence of Intended Use

In determining whether a product is a “drug” because of intended use, the FDA is not bound by a manufacturer’s subjective claims of intent.¹⁶ Actual therapeutic intent may be found on the basis of any objective evidence. Such evidence may be inferred from “labeling, promotional material, advertising, and any other relevant source.”¹⁷

      Unlike the definition of “drug,” the FD&C Act definition of “food” lacks any reference to intent. Nonetheless, a court may consider the intended use of the product in considering whether it is a food. However, a manufacturer’s subjective intent that a product should not be consumed will not allow the product to avoid the reach of the FD&C Act if the product looks like food and smells like food.

2.4 OTHER CONSIDERATIONS

      2.4.1 Products Intended to Be Processed into Food

A number of articles have been deemed to be “food” within the meaning of the FD&C Act definition because they are intended to be processed into a food or a component of food.

       Green coffee beans—It makes no difference if the beans require further roasting and processing before they would be ready for consumption.¹⁸

       Live beef cattle—The СКАЧАТЬ