FDA ISSUES 12/19/2012 SPECIFIC PROMOTIONAL PRODUCTS ISSUES

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Kerry Cobb
6 years ago
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tionaries, i.e. candy, gum, mints, and natural health products DRUGS (What makes a product a drug?

1 FDA ISSUES How To Stay on the Sweet Side of the Law; FDA Issues that affect the Promotional Products Industry SPECIFIC PROMOTIONAL PRODUCTS ISSUES FOOD (including confectionaries, i.e. candy, gum, mints, and natural health products DRUGS (What makes a product a drug?) COSMETICS S (What makes a product a cosmetic?) Can a product be both a drug and a cosmetic? LABELING OF ALL OF THE ABOVE 1

2 FOOD AND FOOD PRODUCTS egulatoryinformation/default.htm Am I a food facility? manufacture, process, pack, or hold food for human consumption in the U.S. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) Every facility must be registered Biennially in even numbered years with the FDA DRUGS ceregulatoryinformation/default.htm Definition Products intended dto treat tor prevent disease, or affect the structure or function of the body. Sunscreen Dandruff Acne Antiperspirants DRUGS, cont. If they are nonprescription (over the counter [OTC]drugs, they must conform to special regulations, called "monographs," for their category. 21 CFR Part 330 Sunscreen monograph is found at 64FR27666, which is here: pprovalprocess/developmentresources/over the CounterOTCDrugs/StatusofOTCRulemakings/ucm pdf (28 Pages) 2

3 COSMETICS plianceregulatoryinformation/default.htm Definition "articles intended dto be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. COSMETICS, cont. Examples products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, p cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. HOW DO I TELL THE DIFFERENCE? Claims (included on label, website, advertising) Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells. 3

4 DIFFERENCE? Cont. Examples Sunscreen (SPF claim) Lip Balm (as opposed to lip moisturizer) Also include SPFclaim? Drugs need approval; cosmetics do not. Approval for Drugs Must Register Site Must obtain Labeler Code DIFFERENCE? Cont. Registration information egulatoryinformation/drugregistrationandlisting/ default.htm Good Luck! LABELING STANDARD Food Rule: oodlabelingnutrition/foodlabelingguide/default.htmexamples Drugs Rule: s/ucm pdf Examples Cosmetics Rule: For free cosmetic samples, companies are only required to list the following information on product labels: (1) the name and place of business of the manufacturer, packer, or distributor (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count (3) statement of identity The identity of the cosmetic sample may be expressed in terms of the common or usual name of the cosmetic, a descriptive name, or when the nature of the cosmetic is obvious, a fanciful name. It may also be expressed in form of an illustration. (letter from FDA dated: 2/24/2012 Examples 4

5 QUESTIONS? Richard D. Massey, JD, MBA, TAS Regulatory Affairs/Compliance Counsel SnugZ USA, Inc S 5070 West Salt Lake City, UT richard@snugzusa.com 5

ASKANESTHETICIAN'S BLOG. What Are Cosmeceuticals? January 17, categories. 1 de 6 02/09/ :00 ABOUT

ASKANESTHETICIAN'S BLOG. What Are Cosmeceuticals? January 17, categories. 1 de 6 02/09/ :00 ABOUT ASKANESTHETICIAN'S ABOUT BLOG An esthetician explores skincare issues and concerns What Are Cosmeceuticals? January 17, 2011 Filed under: Beauty/Cosmetic Products,Skincare products askanesthetician @ 9:55