{"id":152,"date":"2019-07-31T20:32:13","date_gmt":"2019-07-31T20:32:13","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-support\/?p=152"},"modified":"2019-07-31T20:32:13","modified_gmt":"2019-07-31T20:32:13","slug":"cosmetics-vs-drugs","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-support\/2019\/07\/31\/cosmetics-vs-drugs\/","title":{"rendered":"Cosmetics vs Drugs"},"content":{"rendered":"\n

Cosmetics<\/a> are defined by FD&C Act as articles intended to 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. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.<\/p>\n\n\n\n

Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.<\/p>\n\n\n\n

Some products meet the definition of both cosmetic and\ndrugs. For example, a cleansing shampoo is a cosmetic as its intended use is to\ncleanse the hair. An antidandruff treatment is a drug as its intended use is to\ntreat dandruff. As a result, an antidandruff shampoo would fall under both\ncosmetic as well as drug. Another example is that of a toothpaste with\nfluoride, anti-perspirant deodorants, moisturizer with sun protection claims.<\/p>\n\n\n\n

A product\u2019s intended use is determined based on either the\nclaims made on the label, advertisements, company website, general perception\nabout the product in consumers mind or by the ingredients present in the\nproduct.<\/p>\n\n\n\n

The FDA requirements of cosmetics and drugs are different.\nBelow is an outline of the key differences:<\/p>\n\n\n\n

  1. FDA approval \u2013 FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA\u2019s OTC monograph. <\/li>
  2. GMP \u2013 FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with. <\/li>
  3. FDA registration<\/a> \u2013 Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.<\/li>
  4. Labels \u2013 Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.<\/li>
  5. NDC number<\/a>: Drug products are required to have a labeller code while cosmetics are exempt from the requirement<\/li><\/ol>\n\n\n\n

    Liberty Management Group Ltd provides assistance with FDA\nRegistration for Drugs and Cosmetic Establishments, Label compliance, US Agent\nservice and many more FDA regulations. <\/p>\n\n\n\n

    Namrata<\/em><\/p>\n\n\n\n

    FDA Regulatory Consultant<\/em><\/p>\n\n\n\n

    support@libertymanagement.us<\/em><\/p>\n\n\n\n

    http:\/\/www.fdahelp.us<\/a><\/p>\n\n\n\n

    Published on: July 31, 2019<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Cosmetics are defined by FD&C Act as articles intended to 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. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc. Drugs, on the other hand, … Continue reading “Cosmetics vs Drugs”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,38],"tags":[2,54],"class_list":["post-152","post","type-post","status-publish","format-standard","hentry","category-cosmetics-regulations","category-us-fda-registration","tag-fda-registration","tag-ndc-number"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/152","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/comments?post=152"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/152\/revisions"}],"predecessor-version":[{"id":153,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/152\/revisions\/153"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/media?parent=152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/categories?post=152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/tags?post=152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}