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Topic: Federal Food, Drug, and Cosmetic Act

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	FDA act
		Federal Food and Drug Act of 1906—prohibited adulterated or misbranded drugs from interstate commerce.
		In the case of a prescription drug or a restricted device, advertisements that fail to include the generic or established name of the drug and a brief statement in summary form of the side effects, warnings, contraindications, effectiveness, and quantitative formula would be considered misbranding of the advertised product.
		A new use for a drug is claimed even though the drug is not new when used in the treatment of another disease, that is, as addition to the listed indications for drug use.
	www.jcjc.cc.ms.us /DEPTS/pharmacy/FDA_act.html (2292 words)

	FDA Consumer - The Story Of The Laws Behind The Labels: Part II, 1938--The Federal Food, Drug, and Cosmetic Act (Site not responding. Last check: 2007-10-09)
		The six-page Wiley law prohibited the manufacture and interstate shipment of "adulterated" and "misbranded" foods and drugs.
		By 1913, food manufacturers, alarmed by growing variety of State weight and measure laws, sought uniformity through the Gould Amendment to the Federal law -- requiring net contents to be declared, with tolerances for reasonable variations.
		Food adulteration continued to flourish because judges could find no specific authority in the law for the standards of purity and content which FDA had set up.
	vm.cfsan.fda.gov /~lrd/histor1a.html (1219 words)

	MLM Law - Lawyer Grimes & Reese PLLC - Attorney Specializing in Multilevel Marketing - FDA/CFSAN Cosmetics 21 CFR 700 ...
		Any cosmetic product containing chloroform in residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient, is not, for the purpose of this section, considered to contain chloroform as an ingredient.
		Because most cosmetic liquid oral hygiene products and vaginal products are not now packaged in tamper-resistant retail packages, there is the opportunity for the malicious adulteration of those cosmetic products with health risks to individuals who unknowingly purchase adulterated products and with loss of consumer confidence in the security of cosmetic product packages.
		Such a cosmetic product for retail sale that is not packaged in a tamper- resistant package or that is not properly labeled under this section is adulterated under section 601 of the act or misbranded under section 602 of the act, or both.
	www.mlmlaw.com /library/statutes/federal/cfr700b.html (2627 words)

	EPA: Federal Register: Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide ...
		Under FFDCA, EPA has the authority to set tolerances or establish an exemption from the requirement of a tolerance for pesticide residues in or on raw agricultural commodities and to establish food additive regulations for pesticide residues in or on processed foods.
		For plant-pesticides derived from a food plant that is not sexually compatible with the recipient food plant, there is experience with exposure because both plants have contributed to the food supply.
		Such a crop cannot be sold or distributed for use as food or feed unless a tolerance or exemption from the requirement of a tolerance has been obtained for the plant- pesticide in that crop and the plant-pesticide residues fall within the tolerance limits.
	www.epa.gov /fedrgstr/EPA-PEST/1994/November/Day-23/pr-52.html (16562 words)

	FD&C Act Chapters I and II
		A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), 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.
		The amendments made to this Act by the Drug Amendments of 1962 included amendments establishing the requirement that new drugs be effective.
	www.fda.gov /opacom/laws/fdcact/fdcact1.htm (2965 words)

	Office Of Consumer Litigation
		In general, the FDCA requires that drugs and devices be safe and effective for their intended uses, and that food, drugs, and devices be accurately labeled and handled in ways that prevent them from becoming contaminated.
		Actions seeking the condemnation of food, drugs, or devices that are adulterated or misbranded, are handled similarly within FDA to the cases described above.
		Foods, drugs, or devices which are misbranded or adulterated, or which have not received required FDA approval, may be condemned pursuant to 21 U.S.C. For example, the United States filed a seizure complaint against approximately 15,000,000 pounds of cocoa beans that were stored in unsanitary conditions in warehouses in Norfolk, Virginia.
	www.usdoj.gov /civil/ocl/monograph/fdca.htm (3299 words)

	Purina.ca
		Pet foods are subject to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act, voluntary USDA inspection and regulations promulgated by the U.S. FDA, USDA and state agencies.
		Food is defined by the Federal Food, Drug and Cosmetic Act to mean articles used for food or drink for man or other animals and articles used for components of any such article.
		The Food, Drug and Cosmetic Act is a rather comprehensive act which prohibits, among other things, the shipment of adulterated or misbranded pet foods, provides for proper clearances of drugs and food additives and provides for manufacturing plant inspections.
	www.purina.ca /fr/cats/nutrition.asp?article=2 (1465 words)

	Federal Food, Drug, and Cosmetic Act - Valid Prescription - 21 USC Sec. 353 (Site not responding. Last check: 2007-10-09)
		Federal Food, Drug, and Cosmetic Act - Valid Prescription - 21 USC Sec.
		The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
		The FDCA prohibits the manufacture and distribution of misbranded and adulterated drugs, mandates labeling standards, and requires that drugs be handled in a manner that will prevent contamination or misuse.
	www.anorectic-drugs.com /drugs/21usc353_valid_prescription.html (310 words)

	Federal Food, Drug, and Cosmetic ACT
		The Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) direct the Environmental Protection Agency to consider a number of new factors in determining safe levels of pesticide residues on food.
		The Food Quality Protection Act (FQPA) requires that tolerances be "safe", defined as "a reasonable certainty that no harm will result from aggregate exposure", including all exposure through the diet and other non-occupational exposures, including drinking water, for which there is reliable information.
		This had paradoxical effects in terms of food safety, since alternative pesticides could pose higher (non-cancer) risks and EPA allowed the same pesticide in other foods based on a determination that the risk was negligible.
	npic.orst.edu /fqpa/ffdca.htm (1648 words)

	Simmons, Cameron and Simmons, Melissa, Drugs and Dietary Supplements: Ramifications of the Food Drug and Cosmetic Act ... (Site not responding. Last check: 2007-10-09)
		The Federal Food, Drug, and Cosmetic Act was passed in 1938 in response to a tragedy involving elixir of sulfanilamide, which reportedly killed nearly one hundred people.
		Federal Food, Drug, and Cosmetic Act of 1938, § 201(h), Pub.
		The recommended daily allowance ("RDA") published by the Food and Nutrition Board of the NAS/NRC was between 4,500 and 5,000 IU of Vitamin A for older children and adults, 6,000 IU during pregnancy and 8,000 IU during lactation.
	www.wvu.edu /~law/wvjolt/Arch/Simm1/Simm1.htm (3852 words)

	Genetically Engineered Food Safety Act
		(8) The food additive process gives the Food and Drug Administration discretion in applying the safety factors that are generally recognized as appropriate to evaluate the safety of food and food ingredients.
		Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
		(2) USER FEES- With respect to a genetic food additive described in paragraph (1), such paragraph does not waive the applicability of section 409A of the Federal Food, Drug, and Cosmetic Act to a petition under section 409(b)(1) of such Act that is filed before the expiration of the two-year period described in such paragraph.
	www.theorator.com /bills108/hr2917.html (3482 words)

	The Federal Food, Drug, and Cosmetic Act (Site not responding. Last check: 2007-10-09)
		The Federal Food, Drug, and Cosmetic Act requires that all new animal drugs be approved by the FDA.
		The use of an approved animal drug based on labeled directions (type of animal, medical conditions, route of administration, withdrawal, milk discard time, etc.) ensures that food from those treated animals will not contain illegal drug residues.
		Therefore, persons involved in raising, handling, transporting, and marketing food producing animals are to establish systems to ensure that animal drugs are used properly and to prevent illegal drug residues.
	www.ext.vt.edu /news/periodicals/dairy/1996-01/fed-fdc-act.html (286 words)

	MLM Law - Lawyer Grimes & Reese PLLC - Attorney Specializing in Multilevel Marketing - FDA/CFSAN Cosmetics 21 CFR 2
		(3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.
		A suitable color for this use is one that is in sufficient contrast to the natural color of the food seed as to make admixture of treated, denatured seeds with good food easily apparent, and is so applied that it is not readily removed.
		This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipments of vegetables, other edible food, or animal feed in used crates, bags, or other containers that may render the contents injurious to health.
	www.mlmlaw.com /library/statutes/federal/cfr2.html (2147 words)

	Federal Food, Drug, and Cosmetic Act - Wikipedia, the free encyclopedia
		The United States Federal Food, Drug, and Cosmetic Act (FDandC) is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
		The definition of "food additive" is "any substance, the intended use of which results directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food".
		These regulations apply to foods produced by genetic engineering and if the protein added to the food by the genetic engineering process is not "generally recognized as safe" then genetically modified food is regarded as containing a "food additive" and is subject to pre-market approval by the FDA
	en.wikipedia.org /wiki/Federal_Food,_Drug,_and_Cosmetic_Act (943 words)

	CHAPTER 418* UNIFORM FOOD, DRUG AND COSMETIC ACT
		In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the commissioner and director, acting jointly, shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label.
		To the extent that compliance with the requirements of clause (A) (ii) or clause (B) is impracticable, exemptions shall be established by regulations promulgated by the commissioner and director, acting jointly, or by regulations issued under the federal act.
		For the purpose of this subsection, "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution, and the chemically synthesized equivalent of any such substance.
	www.cga.ct.gov /2005/pub/Chap418.htm (4402 words)

	Legal Definition: Nicotine Is a Drug and Cigarettes a Drug-Delivery Mechanism According to Independent Analysis
		In August 1995, the federal Food and Drug Administration (FDA), proposed a rule to give it the power to regulate certain tobacco products containing nicotine on the basis that they meet the legal definition of drugs under the federal Food, Drug, and Cosmetic Act.
		An independent analysis of this issue from a public health perspective, conducted by researchers at St. Peter's Medical Center under this grant, concluded that nicotine is a drug and that cigarettes qualify as drug-delivery devices under the definition of current food and drug laws.
		The study concluded that nicotine is a drug and that cigarettes qualify as drug-delivery devices under the definition of current food and drug laws.
	www.rwjf.org /reports/grr/026766.htm (659 words)

	FOOD AND DRUG LAW
		A Legislative history of the federal food, drug and cosmetic act and its amendments.
		Food and Drug Administration Modernization Act of 1997: FDAMA report on FDA plan for statutory compliance.
		Food safety: federal efforts to ensure the safety of imported foods are inconsistent and unreliable: report to the Chairman, Permanent Subcommittee on Investigations, Committee on Governmental Affairs, U.S. Senate.
	www.dsl.psu.edu /library/lrr/guides/fooddrug/fdbib.html (1688 words)

	EPA: Federal Register: Updated List of Pesticides and Uses Potentially Affected by the Delaney Clause of the Federal ...
		Under section 409 of FFDCA, EPA sets food additive tolerances for pesticide residues that concentrate in processed foods above raw food tolerances, or are the result of pesticide application during or after food processing.
		EPA has also added to List II pesticides used for direct treatment of processed food, food handling equipment, and other uses which are likely to result in residues in the processed food.
		Consistent with the directive contained in Public Law 103 124, the appropriations act including EPA funding for FY94, on December 23, 1993, the Agency issued a notice to registrants informing them that dried hops are reclassified as a raw agricultural commodity (RAC).
	www.epa.gov /fedrgstr/EPA-PEST/1996/March/Day-22/updated.html (1941 words)

	Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act -- Wax 122 (6): 456 -- Annals of ...
		Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act
		Pioneer statute: the pure food and drugs act of 1906.
		The food, drug, and cosmetic act of 1938: its legislative history and its substantive provisions.
	www.annals.org /cgi/content/full/122/6/456 (3469 words)

	Federal Food, Drug, and Cosmetic Act Table of Contents
		Federal Food, Drug, and Cosmetic Act Table of Contents
		Section 108 of Animal Drug Amendments of 1968
		Cross-reference of FD&C Act and U.S. Code section numbers
	www.fda.gov /opacom/laws/fdcact/fdctoc.htm (58 words)

	FEDERAL FOOD, DRUG, AND COSMETIC ACT, sec 321
		FEDERAL FOOD, DRUG, AND COSMETIC ACT, sec 321
		(f) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any other such article.
		(aa) The term "infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
	www.uvm.edu /nusc/nusc237/201.html (915 words)

	The Delaney dilemma - the Delaney clause of the Federal Food, Drug, and Cosmetic Act - Safety First: Protecting ... (Site not responding. Last check: 2007-10-09)
		One legal scholar has called it "the most famous federal health statute." Earlier this year a federal appeals court, with what it termed "some reluctance," ordered FDA to follow that statute to the letter, adding that Congress had taken an "extraordinarily rigid" position in framing the legislative language.
		But Congress, responding to strong demands from consumers, health professionals, and the food industry, adopted legislation that allows saccharin to stay on the market and requires labeling to warn that it is an animal carcinogen.
		Thus, the Delaney clause continues to prohibit the use of carcinogenic dyes in food and drugs.
	www.findarticles.com /p/articles/mi_m1370/is_n7_v22/ai_6760702 (665 words)

	Food and Drug Administration Safety Act of 2005
		This Act may be cited as the `Food and Drug Administration Safety Act of 2005'.
		`(a) Establishment of the Center for Postmarket Drug Evaluation and Research- There is established within the Food and Drug Administration a Center for Postmarket Drug Evaluation and Research (referred to in the section as the `Center').
		The Center for Postmarket Drug Evaluation and Research shall be a separate entity within the Food and Drug Administration and shall not be an administrative office of the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research.
	www.theorator.com /bills109/s930.html (2590 words)

	Progressive Convergence: Revised Mercury-free Drugs Act 2005
		The Mercury-Free Drugs Act 2005 herein, is being proposed to various Congressmen and women in the 109th Congress.
		To amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through drugs and for other purposes.
		Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the Commissioner of Food and Drugs shall submit a report to the Congress annually on the progress of the Commissioner in removing mercury from vaccines.
	www.progressiveconvergence.com /revised-mercury-free-drugs-act2005.htm (1836 words)

	Bill: HR 2763 IH, Internet Pharmacy Consumer Protection Act, 8/5/99.
		To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale of prescription drugs through the Internet.
		This Act may be cited as the `Internet Pharmacy Consumer Protection Act'.
		The preceding sentence may not be construed as affecting the authority of such Secretary to promulgate such a final rule.
	www.techlawjournal.com /cong106/drugs/hr2763ih.htm (876 words)

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