April 4 (Today) Star Tribune

1. April 4 (Today) Star Tribune • 3 more landfills have 3M chemicals • Mercury emissions goals for state get federal OK • Bush bows to ruling on greenhouse gas, but seeks to attach two conditions • FDA proposes allowing irradiation of some food without labeling it as such

2. Two Important Supreme Court Opinions • Massachusetts v EPA • Slip Opinion of the Supreme Court • Environmental Defense • Environmental Defense v. Duke Energy Corp. • Environmental Defense v. Duke Energy Corp. • Slip Opinion of the Supreme Court

3. Drugs and Cosmetics

4. Food and Drug Act of 1906 • Federal Food, Drug, and Cosmetic Act (June 25, 1938, 52 Stat. 1040; 21 USC 301-399) • Food and Drug Administration Act of 1988 Pub. L. 100-607, title V, Nov. 4, 1988, 102 Stat. 3120 • Food and Drug Administration Modernization Act of 1997 Pub. L. 105-115, Nov. 21, 1997, 111 Stat. 2296 • Food and Drug Administration Revitalization Act Pub. L. 101-635, Nov. 28, 1990, 104 Stat. 4583 • Orphan Drug Act Pub. L. 97-414, Jan. 4, 1983, 96 Stat. 2049 • Orphan Drug Amendments of 1985 Pub. L. 99-91, Aug. 15, 1985, 99 Stat. 387 • Orphan Drug Amendments of 1988 Pub. L. 100-290, Apr. 18, 1988, 102 Stat. 90

5. Law • LexisNexis Congressional • 21 USCS 301 • Federal Food Drug and Cosmetic Act (FDA)

6. Definitions 21 U.S.C. 321 • (f) The term "food" means • articles used for food or drink for man or other animals, • chewing gum, and • articles used for components of any such article

7. (g)(1) The term "drug" means • (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them • (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals • (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals • (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)

8. A food or dietary supplement for which a claim, … is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim • A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement

9. Counterfeit drug • (2) The term … means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor

10. The term "cosmetic" means • articles 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 • articles intended for use as a component of any such articles; except that such term shall not include soap.

11. Drugs • Any substance taken primarily for non-dietary needs • Synthetic or non-synthetic • Usually synthesized outside of an organism • Introduced into an organism to produce some effects or alter some bodily functions • relieving symptoms • curing diseases • preventive medicine • Insulin is a hormone produced by the pancreas but can be introduced into the body as a drug • Eastern philosophy considers food a drug as it affects particular parts of body and cures some diseases • Some substances, such as beers, wines, and some fungi, are sometimes regarded as both foods and drugs – let’s add chocolate!

12. Drug • Defined in the Federal Food, Drug, and Cosmetic Act as • an article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" or an article "(other than food) intended to affect the structure or any function of the body of man or other animals." FDCA 201(g)(1) • List of Drugs (Wikipedia)

13. Medication • Drug taken • to cure and reduce symptom of an illness or medical condition, • as a preventive – having some future benefit but not treating existing or pre-existing diseases or symptoms • Dispensing such drugs is often regulated by the government • over the counter medications available without restriction • generally considered to be safe enough when taken as instructed • behind the counter dispensed by a pharmacist without a doctor's prescription • prescription only medicines must be prescribed by a licensed medical professional, usually a physician

14. Medications • Typically manufactured by pharmaceutical companies • Usually patented to protect the exclusive rights to produce them, • Those not patented, or with expired patents, are called generic drugs since they can be produced by other companies without restrictions or licenses from the patent holder • Can be derived from naturally occurring substance in plants- herbal medicine • Drugs, Supplements and Herbal Information (MedLine)

15. Orphan Drugs • Office of Orphan Products Development (FDA) promotes the development of products demonstrating promise for the diagnosis and/or treatment of rare diseases or conditions • Orphan Drug Act (as amended) (FDA) • 21 CFR 316 Orphan Drugs • Authorized by 21 USC 360aa, 360bb, 360cc,360dd, 371 • Health Care and Intellectual Property: The Orphan Drug Act (Consumer Project on Technology) • The Orphan Drug Act: An Engine of Innovation? At What Cost? (Patricia J. Kenney)

16. Food and Drug Administration • Mission • to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation • to advance the public health by • helping to speed innovations that make medicines and foods more effective, safer, and more affordable • helping the public get the accurate, science-based information they need to use medicines and foods to improve their health

17. Drugs at FDA

18. National institute for Drug Abuse • Mission • to lead the Nation in bringing the power of science to bear on drug abuse and addiction  • to support and conduct research across a broad range of disciplines  • to ensure the rapid and effective dissemination and use of the results of that research to significantly improve prevention, treatment and policy as it relates to drug abuse and addiction 

19. Drug Enforcement Administration • Mission • to enforce the controlled substances statutes and regulations of the United States and to apprehend (and bring to the criminal and civil justice system of the United States) those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States • to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets

20. Bureau of Alcohol, Tobacco, and Firearms • Mission • to prevent terrorism, reduce violent crime, and protect the Nation • to enforce Federal criminal laws and regulate the firearms and explosives industries • to investigate and reduce crime involving firearms and explosives, acts of arson, and illegal trafficking of alcohol and tobacco products • The Homeland Security Act of 2002 created the Department of Homeland Security • Transferred ATF from the Treasury Department to the Justice Department

21. Claims for Drugs • “Miracle” Health Claims; Add a Dose of Skepticism (Federal Trade Commission)

22. Health Claim on Food Labels • Claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition • Manufacturers of oat cereals that oat bran can reduce cholesterol which will lower the chances of developing serious heart conditions • Usually referred to as "qualified health claims" and regulated by the FDA • 21 CFR101.14 • 21 CFR 101 Food Labeling • Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease (64 Federal Register 57699-57733 October 26, 1999) • The current rule requires "significant scientific consensus" before a claim can be made • Characterizes claims using degrees of certainty

23. Health Claim on Food Labels • A: "There is significant scientific agreement for [the claim]" • B: "Although there is some scientific evidence supporting [the claim], the evidence is not conclusive." • C: "Some scientific evidence suggests [the claim]. However, the F.D.A. has determined that this evidence is limited and not conclusive." • D: "Very limited and preliminary scientific research suggests [the claim]. The F.D.A. concludes that there is little scientific evidence supporting this claim." • A Food Labeling Guide – Appendix C (Center for Food Safety and Applied Nutrition) • Looser rules proposed for health claims on food labels (New York Times) • Claims that can be made for conventional foods and dietary supplements (FDA) • Blurred line between food and drugs (News in Science)

24. Dietary Supplements • Overview of dietary supplements (FDA) • "Nutraceuticals": Do They Spell the End of FDA Regulation of Drugs? (Maxwell J. Mehlman, J.D.) • Dietary supplements in the US: pitfalls and safety (Nature.com) • Dietary Supplements: A Rapidly Growing Market (Medscape) • Dietary Supplements and Drugs: Is the Line Blurred? (Regulatory Affairs Professional Society)

25. Cosmetics • Substances used to enhance or protect the appearance or odor of the human body • Skin-care creams, lotions, powders, perfumes, lipsticks, fingernail polishes, eye and facial makeup, permanent waves, hair colors, deodorants, baby products, bath oils, bubble baths • Use is widespread, especially among women in Western countries • A subset of cosmetics is called "make-up", which refers primarily to colored products intended to alter the user’s appearance • Manufacture of cosmetics is currently dominated by a small number of multinational corporations that originated in the early 20th century, but the distribution and sale of cosmetics is spread among a wide range of different businesses.

26. The term "cosmetic" means (1) articles 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 (2) articles intended for use as a component of any such articles; except that such term shall not include soap” FD&C Act, Sec. 201 (i) • This broad definition includes, as well, any material intended for use as a component of a cosmetic product. • Clearing up Cosmetic Confusion (FDA Consumer Magazine) • Cosmetics and Your Health (Department of Health and Human Services) • Lipstick (Chemical and Engineering News)

27. Ingredients derive from a variety of sources • Colors derive from sources ranging from crushed insects to rust • Modern techniques have allowed manufacturers to produce colors synthetically • The ingredients used in cosmetics are highly regulated • Cosmetics (FDA) • Testing of cosmetic products on animals is a subject of some controversy • It is now illegal in the United Kingdom, the Netherlands, and Belgium, and a ban across the European Union is due to come into effect in 2009

28. Legal information for those injured by drugs and medical devices • Current Lawsuits (Prescription Access Network) • Mass Tort Drug Litigation