● Its label does not include all required information. (An exemption may apply to cosmetics that are to be processed, labeled, or repacked at an establishment other than where they were originally processed or packed. ● The required information is not adequately prominent and conspicuous. ● "Its container is so made, formed, or filled as to be misleading.” ● It is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and ● "Its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602) Under the FD&C Act, a product also may be misbranded due to failure to provide material facts. This means, for example, any directions for safe use and warning statements needed to ensure a product's safe use. In addition, under the authority of the FPLA, FDA requires a list of ingredients for cosmetics marketed on a retail basis to consumers (Title 21, Code of Federal Regulations (CFR), section 701.3). Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. (FPLA, section 1456) This requirement does not apply to cosmetics distributed Environmental Protection Agency (2022). List A: Antimicrobial Products Registered with the EPA as Sterilizer s. Retrieved April 3,2022 from https://www.epa.gov/pesticide-registration/ list-antimicrobial-products-registered-epa-sterilizers Food and Drug Administration (2022a). FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved but Are FDA-Regulated . Retrieved April 2,2022 from https://www.fda. gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are- not-fda-approved-are-fda-regulated#top Food and Drug Administration (2022b). Hair Dyes. Retrieved on April 5, 2022, from https:// www.fda.gov/cosmetics/cosmetic-products/hair-dyes Occupational Safety and Health Administration. (2017). Worker’s Rights . Retrieved April 4, 2022, from https://www.osha.gov/sites/default/files/publications/osha3021.pdf References ________ means confined to the nonliving cells of the epidermis, specifically the stratum corneum or layer. a. Ablating. b. Non-invasive. c. Excising. d. Lancing. 2. ________ cells must never be altered, cut, or damaged. a. Diseased. b. All. c. Skin. d. Living. 3. ________ means a material that permits fluids, gases, or debris to be absorbed or to pass through. a. Opaque. b. Penetrable.
solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities. FDA can take action against cosmetics on the market that are in violation of these laws, as well as companies and individuals who market such products. On October 30, 2018, the FDA(2022b) published a final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. On April 1, 2019, the final rule was stayed because the agency received objections to its decision and a public hearing was requested within the allowable timeframe. The agency has reviewed the objections and has determined that they did not raise issues of material fact that justify a hearing. Therefore, on January 6, 2022, the final rule was made effective. We intend to exercise enforcement discretion for 12 months following the effective date to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing lead acetate. The FDA often receives questions about the safety and regulation of hair dyes. Most of these products belong to a category called “coal-tar” hair dyes. Color additives, except for coal-tar hair dyes, need FDA approval before they’re permitted for use in cosmetics. Occupational Safety and Health Administration (2021) Health Hazards in Nail Salons . Retrieved April 2, 2022, from https://www.osha.gov/nail-salons. Ohio Cosmetology and Barber Board (2019). Ohio Administrative Code Chapter 4713-1-01 Definitions . https://codes.ohio.gov/ohio-administrative-code/4713. Retrieved April 2, 2022, https://codes.ohio.gov/ohio-administrative-code/rule-4713-1-01 Ohio Cosmetology and Barber Board (2022). Ohio Administrative Code Chapter 4713 . Retrieved April 1, 2022, from https://codes.ohio.gov/ohio-administrative-code/4713 Ohio Department of Public Safety (2021) Governor’s Human Trafficking Task Force Report . Retrieved April 7, 2022, from https://humantrafficking.ohio.gov/links/ OhioHumanTraffickingTaskForceReport1121.pdf Polaris (2021). Human Trafficking: Ohio’s Tragic Reality . Retrieved April 7, 2022, from https:// www.humantrafficking.ohio.gov/links/LaborTraffickingFactSheet.pdf.
ADMINISTRATIVE RULES AND STANDARDS Final Examination Questions Select the best answer for each question and mark your answers on the Final Examination Answer Sheet found on page 26, or complete your test online at EliteLearning.com/Book 1.
4. ________ means a non-invasive, non-medical, and non- healing service, such as aromatherapy or other relaxation services. a. Therapy. b. Treatment. c. Service. d. Procedure. 5. A salon or school of cosmetology provided a copy of the sanitary standards shall post the standards in a ________
place in the salon or school. a. Public and conspicuous. b. Safe and open. c. Obvious. d. Visible.
6. Performing or providing services that are not within the scope of cosmetology, or branch of cosmetology for which the individual is licensed is a ________. a. Felony. b. Criminal act. c. Prohibited act. d. Fatal flaw.
c. Porous. d. Soluble.
Book Code COH0325A
Book Code: COH0325A
Page 7
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