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I. FDA FTC Shared Authority over OTC Advertising Because consumers must take most efficacy and other advertising claims for OTC drugs on faith, drug manufacturers should follow high standards for substantiating such claims. This philosophy was made clear in an October 1990 speech delivered by the director of the FTC's Bureau of Consumer Protection before the Nonprescription Drug Manufacturers Association "NDMA" ; .17 The FTC recognized that the OTC drug manufacturers have "a special responsibility. It is the obligation to tell the truth, expressly and impliedly, and not to stop at half the truth." The most basic criterion the agency looks to is the amount of consumer injury caused by the questionable advertising such that the degree of the potential risk to the user's health is a critical factor. Press Release, FTC's Cutler Says OTC Drug Manufacturers Must Have High Advertising Standards, at : ftc.gov opa predawn F93 bjc-otc-a1 October 23, 1990 ; . Accordingly, the jurisdictions of the FDA and the FTC do overlap in the area of OTC drug advertising. 48 Food & Drug L.J. 321, 340 1993 ; . The FDA's authority derives from the requirement that any drug sold in the United States must have FDA approval, including preapproval of all drug package labeling. The FTC's authority encompasses the power to regulate any false or deceptive advertising or unfair trade practices, even in the OTC drug industry. Advertising for a drug product sold over the counter must be substantiated by reliable scientific evidence, and, if the ads claim clinical experience, the data must be well controlled to the degree that the FDA would normally demand. 1 FDA2D 15: 12 citing FTC v. Calif. Pac Research, Inc., Civ. N-88-602 D. Nev. Aug. 27, 1991 . To avoid parallel actions and promote uniformity and consistency in actions related to drug advertising, in 1971 the two agencies agreed to a and zoloft, because zithromax and birth control.
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Chapter Notes. 1.This Chapter does not cover : a ; b ; 2.Yeasts heading 21.02 Blood fractions other than blood albumin not prepared for therapeutic or prophylactic uses ; , medicaments or other products of Chapter 30; Enzymatic preparations for pre-tanning heading 32.02 Enzymatic soaking or washing preparations or other products of Chapter 34; Hardened proteins heading 39.13 or Gelatin products of the printing industry Chapter 49.
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