The N.C. Food, Drug and Cosmetic Act (NCFDCA) prohibits false and misleading advertising for food, drugs, medical devices and cosmetics.[144] The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate advertising for these products as well depending on the agencies’ jurisdiction and regulatory emphasis in these product categories.
Under the NCFDCA, an “advertisement” is defined in the statutes as “all representations disseminated in any manner or by any means, other than by labeling, for the purposes of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, [medical] devices or cosmetics.”[145] Determining whether an advertisement is misleading under the act takes into account a number of factors, including but not limited to “representations made or suggested by statement, word, design, device, sound, or any combination therefore, [and] also the extent to which . . . [the] advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the . . . [product]” as prescribed or as is customary. In other words, the determination takes into account explicit and implicit claims in the advertisement and also omissions of material information.[146]
In addition to generally prohibiting false and misleading advertisements for foods, drugs, medical devices and cosmetics, the NCFDCA specifically states that an advertisement disseminated to the public (direct-to-consumer) is false if it claims that a drug or medical device has “any effect” on a number of designated diseases and conditions including appendicitis, cancer, diabetes, heart and vascular diseases, high blood pressure, pneumonia, prostate gland disorders, sexual impotence and sinus infections.[147] The state Department of Agriculture and Consumer Services may authorize by regulation direct-to-consumer (DTC) advertisements for drugs that have “curative or therapeutic effect” on any of these diseases and conditions when “advance[s] in medical science” establish that “self-medication” for any of the diseases or conditions is “safe.”[148]
The statutes empower North Carolina’s commissioner of agriculture to impose civil penalties up to $2,000 on anyone violating the NCFDCA[149] and to seek either a temporary or permanent injunction from a superior court to prevent violations of these provisions.[150] In addition, violations of the NCFDCA can draw criminal misdemeanor charges.[151] Media outlets – meaning any “publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement” – cannot be held criminally liable for disseminating a false or deceptive food, drug or cosmetic advertisement unless they refuse a request from the commissioner to identify – by name and address – the person or company that placed the advertisement.[152]
At the federal level, under a 1971 working agreement between the FDA and FTC, the FDA takes primary responsibility for regulating prescription drug advertising (and labeling), while the FTC takes primary responsibility for regulating advertising for food, over-the-counter (OTC) drugs, devices and cosmetics (although the FDA takes primary responsibility for the labeling of these products).[153] Detailed discussion of this complex federal statutory and regulatory framework, including relevant court opinions and agency actions, is beyond the scope of this chapter. However, DTC prescription drug advertising is among the most extensively regulated categories of advertising and promotion at the federal level and is monitored specifically by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). For an excellent overview of FDA regulation of direct-to-consumer prescription drug advertising, visit and download Prescription Drug Advertising: Questions and Answers from the official DDMAC website,[154] including downloadable samples of correct and incorrect examples of print-format direct-to-consumer prescription drug advertisements that are either regulated product claim advertisement, reminder advertisement or help-seeking advertisement type.[155]
[144] N.C. Gen. Stat. § 106-122(5); N.C. Gen. Stat. § 106-138(a). The statutes also prohibit advertising any of these products that misbrand the product. N.C. Gen. Stat. § 106-122(1).
[145] N.C. Gen. Stat. § 106-121(1). “Food” is defined as including “[a]rticles used for food or drink for man or other animals” including chewing gum. Id. at (8)a-c. A “drug” is defined as including “[a]rticles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” and “[a]rticles (other than food) intended to affect the structure of any function of the body of man or other animals.” Id. at (6)a-d. A “device” is defined to include “instruments, apparatus and contrivances, including their components, parts and accessories,” that are intended “[f]or the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or “[t]o affect the structure or any function of the body of man or other animals.” Id. at (5)a-b. A “cosmetic” is defined as including “[a]rticles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance;” and “[a]rticles intended for use as a component of any such articles but does not include soap.” Id. at (4).
[146] N.C. Gen. Stat. § 106-121(15).
[147] N.C. Gen. Stat. § 106-138(b). The complete list is as follows: Albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright’s disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis, media, paralysis, pneumonia, poliomyelitis, infantile paralysis, prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia and venereal diseases. Id. This subsection does not apply to advertisements that are directed to “members of the medical, dental, pharmaceutical, or veterinary professions, or appear[] only in the scientific periodicals of these professions.” Id.
[148] Id.
[149] N.C. Gen. Stat. § 106-124.1(a).
[150] N.C. Gen. Stat. § 106-123.
N.C. Gen. Stat. § 106-124(a).
[152] Id. at (c). The media outlet must furnish the “name and post-office address of the manufacturer, packer, distributor, seller or advertising agency residing in the State of North Carolina who caused him to disseminate [the false or misleading] advertisement.” Id.
[153] 1971 Memorandum of Understanding, supra note 6. For an excellent general discussion of the somewhat complex FDA-FTC regulatory scheme published in 2010, see Maher & Fair, supra note 5, at 602-605.
[154] http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htm (page last updated June 23, 2009).
[155] http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm168421.htm (page last updated June 24, 2009).
