U.S. Food and Drug Administration

U.S. Food and Drug Administration

U.S. Food and Drug AdministrationThe  U.S.  Food  and  Drug Administration (FDA)  is  a  scientific  and  regulatory agency of the federal  government charged with protecting public  health through overseeing the  safety of consumer products. The  FDA  has  various  departments that serve to regulate the beauty  industry: Office of Cosmetics and Colors, Plastic and Reconstructive Surgery  Devices Branch, and Center for Drug Evaluation and Research. The primary laws pertaining to cosmetics marketed in the United States are the Federal  Food,  Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

Federal Food, Drug, And Cosmetic Act

The  FD&C Act  defines  products by  their  intended uses,  including cosmetics, drugs, and medical  devices. The  FDA defines cosmetics as products applied  to the human body  for cleansing, beautifying, or altering appearance, without affecting the  body’s  structure or  function. These include hair  care  products, skin  care products, makeup, and perfume. The  FDA defines  drugs  as products intended for the  diagnosis, cure,  treatment, or prevention of disease  by affecting  the  structure or function of the  body. According to the  FDA, medical  devices  such  as surgical implants are products that  are intended to affect bodily structure or function but do not  achieve  this through the chemical action of a drug.

A product’s intended use as a drug, cosmetic, or medical device is established by claims made in its product labeling, and advertisements. Some products marketed as cosmetics may be considered drugs  if claims establish their  intended use to affect the structure or functions of the human body. For example, hair products that claim to restore hair or prevent hair loss, which may seem to be cosmetic goals, are considered drugs  because of the  mechanism they  use  to invigorate hair  growth. Other products marketed as cosmetics that  are considered drugs  include those that  eliminate cellulite or reduce varicose  veins, acne  medicine, sunscreen, and products designed to treat  hair and skin ailments.

When a product has two intended uses, it must comply  with the requirements for both cosmetics and  drugs. For example,  an antidandruff shampoo is considered both a cosmetic and a drug: it is used  to treat  dandruff (and alter the structure  of the  hair  follicle) and  clean  hair.  Other examples of products with  both cosmetic and  drug  applications are fluoride toothpastes, antiperspirant deodorants,  and moisturizers or makeup that  include sunscreen.

Each  type of product is subject to different laws and  regulations. Drug companies  must register  with  the  FDA  and  list  their  various  drug  products,  while cosmetics companies may choose to register  under the FDA’s Voluntary Cosmetic Registration Program (VCRP). While  the  FDA  reviews  and  approves drugs  and medical  devices  before  they  enter  the  consumer market, cosmetic products and their  ingredients are not  reviewed  before  they are publicly  available.

Soap is a special  category  under the FD&C Act. Soap products are considered neither cosmetics nor  drugs  and  are exempt  from  the  FD&C Act. The  FDA assigns  the  term  soap to a product only  when  it is labeled  and  sold  exclusively  as soap  and  consists primarily  of alkali  salt of fatty acids.  Cleansing products that include detergents and  are intended for cosmetic or health uses  are regulated as cosmetics or drugs, respectively.

Fair Packaging And Labeling Act

The  Fair  Packaging and  Labeling Act (FPLA) is designed to protect consumers from  potential health hazards that  may result  from  cosmetics and  also to guard against  deceptive practices by ensuring accurate labeling  that  can  help  consumers  make  informed decisions about their  cosmetics and  drug  purchases.  Every label  must include an  identity statement indicating the  nature and  use  of the product, an accurate statement of the  contents, and  any applicable safety warnings. Misbranding occurs when  a label is false or misleading or fails to properly give required information. Products with  two intended uses,  such  as drugs  that have  cosmetic purposes, must comply  with  label  regulations for both drug  and cosmetic ingredient labels.

Cosmetic Alterations

The  FDA reviews products implanted into  the body that  could  have health consequences. These include surgical  and  nonsurgical cosmetic alterations. Surgical alterations are categorized as medical  devices. The  FDA regulates the  use  of silicon  implants for breast  augmentation; surgical  procedures such  as stomach flattening, or  tummy tucks;  and  facial cosmetic surgery. The  FDA  also  regulates  products that  affect the  structure of the  face and  could  have  such  health consequences. For example, soft tissue  fillers such  as Restylane  (hyaluronic acid) are approved by the  FDA  to treat  facial wrinkles. The  regulation of such  treatments typically falls under the FDA’s regulation of a drug. For example, Tretinoin (retinoic acid) is not  banned from use in cosmetics, but  when  applied  to the skin to  treat  acne,  sun  damage, and  other skin  conditions, it  alters  the  skin’s  cellular  makeup by increasing collagen, and  thus  the  FDA  regulates it as a drug. When evaluating such  cosmetic treatments, the FDA uses a benefit-to-risk ratio. The  FDA may allow greater  risk from products intended to treat  medical  conditions  than from  those  that  are approved for cosmetic purposes. While  cosmetic products regulated by the  FDA  are  supposed to  be  extraordinarily safe, some consumer groups criticize the regulation of products as too lenient: for example, since fragrance formulas are considered trade secrets, companies are not required to  reveal  fragrance ingredients on  the  label. The  FDA  bans  10 chemicals from use  in cosmetics, but  many  of the  thousand ingredients used  in cosmetics are considered toxic. A recent study  by the Campaign for Safe Cosmetics found that 15 of 33 popular lipsticks  had  detectable traces  of lead. The  FDA claims  that  it does not tolerate high risk for a drug  with a primary use as a cosmetic; nevertheless, what  is safe and  the degree  to which  beauty  products are taken  as seriously as other commodities is continually debated.

FDA Globalization Act

The  FDA  Globalization Act  of 2008  is intended to  provide  the  FDA  with  the authority to regulate food, cosmetics, drugs, and medical  devices in a global marketplace. Under the  act,  companies must register  all cosmetic facilities  serving American consumers, and  these  facilities  must report adverse  events  resulting from  the  use  of their  products. Such  companies must comply  with  American manufacturing practices, and the FDA may monitor foreign  facilities producing food, drugs, devices, and cosmetics for American consumers.




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