Abstract
This chapter covers areas of special regulation. The primary topic will be dietary supplements , followed by the seven rules promulgated under the Food Safety Modernization Act. Other topics will include the regulation of seafood, juice , milk, water, and ice. Each of these areas deserves discussion apart from the coverage of general topics under the FD&C because of specific legislation or rules promulgated to address unique enforcement considerations raised by these products. FSMA fits into this discuss both because many of the rules are product specific, but also because as the first substantive change in 75 years coverage of the rules is ill suited for other chapters.
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Notes
- 1.
Peter Barton Hutt, Government Regulation of Health Claims in Food Labeling and Advertising, 41 Food Drug Cosm. L.J., 7 (1986).
- 2.
Peter Barton Hutt, Government Regulation of the Integrity of the Food Supply, 4 Ann. Rev. Nutrition 1, 8–11 (1984).
- 3.
Hutt 1986 at 7.
- 4.
Id.
- 5.
FDA Regulatory Letter to ITT Continental Baking Company (October 1976).
- 6.
21 CFR 105.65;0.67.
- 7.
FDA TC2-A (November 5, 1945).
- 8.
C.W. Crawford, Statement at His Induction as Commissioner of Food and Drugs (June 1951).
- 9.
Hutt 1986 at 55–56.
- 10.
Id.
- 11.
Id. at 56–57.
- 12.
United States v. 119 Cases…“New Dextra Brand Fortified Cane Sugar,” 231 F. Supp. 551 (S.D. Fla. 1963).
- 13.
United States v. 119 Cases…“New Dextra Brand Fortified Cane Sugar,” 334 F.2d 238 (5th Cir. 1964).
- 14.
United State v. An Undetermined Number of Shipping Pacakges…Labeled in Part “Vitasafe Formula M,” 225 F.Supp. 266 (D.N.J. 1964).
- 15.
United States v. Vitasafe Corp., 345 F.2d 864 (3d Cir. 1965).
- 16.
27 Fed. Reg. 5815 (1962).
- 17.
21 CFR 101.14(c).
- 18.
FDA, Guidance for Industry, Distinguishing Liquid Dietary Supplements from Beverages (Jan. 2014) available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm381189.htm.
- 19.
FDA , Structure Function Rule, 65 FR 4 (2000).
- 20.
Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, available at: http://www.business.ftc.gov/documents/bus09-dietary-supplements-advertising-guide-industry.
- 21.
Person v. Shalala, 164 F.3d 650 (D.C. Circ. 1999).
- 22.
Id. at 653.
- 23.
Id. at 653–654.
- 24.
Id. at 654.
- 25.
Id. at 655.
- 26.
Id.
- 27.
Id. at 656–658.
- 28.
Id.
- 29.
Id. at 659.
- 30.
Pearson v. Shalala, 130 F. Supp.2d 105, 108–109 (D.D.C. 2001).
- 31.
Id. at 115.
- 32.
Id. at 119.
- 33.
248 F.Supp.2d 1, 7 (D.D.C. 2002).
- 34.
Id. at 8.
- 35.
Id. at 11.
- 36.
Alliance for Natural Health US v. Sebelius, 714 F. Supp.2d 48, 57 (D.D.C. 2010).
- 37.
Id. at 57–58.
- 38.
Id. at Fn. 16.
- 39.
Id. at 71.
- 40.
Id.
- 41.
Id.
- 42.
Alliance for Natural Health US v. Sebelius, 786 F.Supp2d 1, 24 (D.D.C. 2011).
- 43.
Id.
- 44.
FDA Fast Facts: FDA’s Support of the Hurricane Relief Effort (available at: https://www.fda.gov/NewsEvents/Newsroom/ucm578139.htm) (September 28, 2017).
- 45.
Shane Starling, Nutra Ingredients, “French cranberry medical device status stripped,” (April 2014) available at: http://www.nutraingredients.com/Regulation/French-cranberry-medical-device-status-stripped.
- 46.
Consumer Affairs Agency, Food Labelling Division, Regulatory Systems of Health Claims in Japan (June 2011) available at: http://www.caa.go.jp/en/pdf/syokuhin338.pdf.
References
Consumer Affairs Agency (2011) Food Labelling Division, Regulatory Systems of Health Claims in Japan. Available at: http://www.caa.go.jp/en/pdf/syokuhin338.pdf. Last visited 27 Aug 2014)
Crawford CW (1951) Statement at His Induction as Commissioner of Food and Drugs
FDA TC2-A (November 5, 1945)
FDA Regulatory Letter to ITT Continental Baking Company (1976)
FDA (2014) Guidance for industry, distinguishing liquid dietary supplements from beverages. Available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm381189.htm. Last visited 27 Aug 2014)
Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, available at: http://www.business.ftc.gov/documents/bus09-dietary-supplements-advertising-guide-industry. Last visited 27 Aug 2014)
Hutt PB (1984) Government regulation of the integrity of the food supply, 4 Ann. Rev. Nutrition 1–20
Hutt PB (1986) Government regulation of health claims in food labeling and advertising, 41 Food Drug Cosm. L.J., 3–73
Starling S (2014) Nutra Ingredients, French cranberry medical device status stripped. Available at: http://www.nutraingredients.com/Regulation/French-cranberry-medical-device-status-stripped
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Sanchez, M.C. (2018). Regulation of Dietary Supplements and Other Specialized Categories. In: Food Law and Regulation for Non-Lawyers. Food Science Text Series. Springer, Cham. https://doi.org/10.1007/978-3-319-71703-6_5
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