Food Regulation. Neal D. Fortin

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СКАЧАТЬ this health claim, a food must contain at least 6.25 grams of soy protein per serving, the amount that is one‐fourth of the effective level of 25 grams per day.

      Sample Claim: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides ____ grams of soy protein.”

5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols²⁷

      Evidence indicates that plant sterol or plant stanol esters may help to reduce the risk of CHD. Plant sterols are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, and other plant sources. Plant stanols, which occur naturally in even smaller quantities, are obtained from refined plant sources, such as vegetable oils.

       Requirements

      In order to qualify for this health claim, a food must contain at least 0.65 grams of plant sterol esters per serving or at least 1.7 grams of plant stanol esters per serving. The claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods. To qualify, foods must also meet the requirements for low saturated fat and low cholesterol, and must also contain no more than 13 grams of total fat per serving and per 50 grams. However, spreads and salad dressings are not required to meet the limit for total fat per 50 grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content. In addition, except for salad dressing and dietary supplements, the food must contain at least 10% of the RDI or DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol.

      Sample Claim: “Foods containing at least 0.65 grams per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams of plant sterol esters.”

5.5 AUTHORITATIVE STATEMENTS – FDA MODERNIZATION ACT

Before the Food and Drug Administration Modernization Act of 1997 (FDAMA), companies could not use a health claim or nutrient content claim in food labeling unless the FDA published a regulation authorizing such a claim. Two new provisions of FDAMA²⁸ permitted distributors and manufacturers to use claims if based on current, published, authoritative statements from certain federal scientific bodies. The National Academies of Sciences (NAS), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC) are federal government agencies specifically identified as scientific bodies by the FDAMA.

FDAMA’s provisions were intended to expedite the process by which health claims can be established and used. FDA interpreted “authoritative statements” so that they must reflect a consensus within the identified scientific body and be based on a deliberative review by the scientific body of the scientific evidence. In theory, the authoritative‐statement standard is slightly less stringent than FDA’s prior requirement for “significant scientific agreement.” Particularly, FDAMA allows companies to notify FDA of their intent to use a new health claim based on an authoritative statement of only one federal scientific body, rather than show scientific agreement. However, in application, the standards show little difference.

      From a process standpoint, FDAMA does require that FDA expedite review. FDAMA gives FDA 120 days to respond to new health claim proposals based on authoritative statements. If the agency does not act to prohibit or modify the claim within that time, the claim can be used.

      Nevertheless, FDAMA’s provisions to expedite approval did not meet the desires of everyone in the food industry. FDAMA sped up FDA’s review, but review often resulted in denial. Two years after FDAMA, two food marketers sued over such a denial. The result was the landmark case, Pearson v. Shalala, which is discussed later in this chapter.

FDA has prepared a guide on how a firm can make use of authoritative statement‐based health claims.²⁹ FDAMA does not include dietary supplements in the provisions for health claims based on authoritative statements. Consequently, this method of oversight for health claims cannot be used for dietary supplements at this time.

As this was written, three health claims based on authoritative statements were approved³⁰:

       Whole Grain Foods and Risk of Heart Disease and Certain Cancers

       Potassium and the Risk of High Blood Pressure and Stroke

       Whole Grain Foods with moderate fat content and heart disease³¹

5.6 QUALIFIED CLAIMS

      “Qualified” health claims are a category of claims demarcated by FDA based on First Amendment concerns. This category of claim is based on the FDA’s acceptance of a petition for a health claim with less than significant scientific agreement when the claim is qualified with an explanation of the degree of scientific support. More on the specific requirements and claims follows below; however, first, the following cases are essential to understanding this category.

      5.6.1 Restricting Commercial Speech

      Before 1976, commercial speech, such as advertising, found no protection under the First Amendment of the U.S. Constitution. Today, commercial speech is deemed to be under a level of First Amendment protection (but remains a lower level of protection than political speech). The Central Hudson case delineates a four‐part analysis of commercial speech. Commercial communication (1) must be determined to be neither false, misleading, nor related to unlawful activity, (2) the government interest must be substantial, (3) the restriction must directly advance that interest, and (4) the restriction cannot be more extensive than necessary to advance the government interest.

      Note that Central Hudson provides two prongs of protection. However, there are broad exceptions to the First Amendment protections. Commercial speech that is false is not protected, and commercial speech that is more likely to deceive the public than to inform it may be banned. In addition, commercial speech related to illegal activity may also be prohibited.

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       Central Hudson Gas & Electric v. Public Service Commission of New York

       447 U.S. 557 (1980)

      Mr. Justice POWELL delivered the opinion of the Court.

      This case presents the question whether a regulation of the Public Service Commission of the State of New York violates the First and Fourteenth Amendments because it completely bans promotional advertising by an electrical utility….

      Central Hudson Gas & Electric Corp., the appellant in this case, opposed the ban on First Amendment grounds….

      The СКАЧАТЬ