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  • Regulatory NewsRegulatory News

    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
  • Regulatory NewsRegulatory News

    Cosmetic Companies, Watch Out: FDA Cracking Down on Improper Claims

    In recent years, a handful of cosmetic manufacturers have come under the harsh scrutiny of the US Food and Drug Administration (FDA) over claims their products could do far more than just change the skin’s aesthetics. Now the agency is again going after a marketer of cosmetic products, saying the company’s creams and moisturizers are more like drugs than beauty products. Background Cosmetic products are lightly regulated by US federal regulators. Unlike drugs, which mus...
  • Are Products Used to Whiten Your Teeth Drugs or Cosmetics? FDA Weighs in

    When is a tooth whitener a cosmetic, and when is it a pharmaceutical or medical device product? The question has never had a clear regulatory answer, and despite the efforts of the American Dental Association (ADA) to obtain one, the US Food and Drug Administration (FDA) says it prefers-for now anyway-a case-by-case approach. Background In 2009, the ADA submitted a Citizen Petition to FDA requesting that the agency "review and establish an appropriate regulatory class...
  • Feature ArticlesFeature Articles

    New EU Regulation on Postmarketing Surveillance of Cosmetic Products

    • 05 February 2014
    Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 1999 on cosmetic products 1 (the Cosmetics Regulation ), governing cosmetic products in the EU, came into force on 11 July 2013. A new and important aspect of the regulation concerns postmarketing surveillance to be carried out by manufacturers, importers and distributors. This article highlights the industry's responsibilities for designating a single point of contact, collecting...
  • FDA Cracks Down on Spurious Marketing Claims for Cosmetic Products

    The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding allegedly unfounded claims used to market various products. In an opening salvo, released in the form of an 11 September warning letter , FDA alleged French cosmetic giant L'Oreal's US subsidiary, Lancôme USA, was using a number of improper marketing claims that caused ...
  • Cosmetic Company L'Oreal Hit by Warning Letter for Questionable Claims

    When does a cosmetic product become a drug? When it's marketed as having advanced features that alter the body's cellular state, explained the US Food and Drug Administration (FDA) in a warning letter sent 11 September 2012 to Lancôme USA, a subsidiary of cosmetics manufacturer L'Oreal. The letter references a number of products marketed by Lancôme, many of which claim to promote a more youthful look and go by names like, "Génifique Cream Serum Youth...
  • FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products

    • 20 April 2012
    The US Food and Drug Administration (FDA) has issued new draft guidance pertaining to the inclusion of nanomaterials in cosmetic products. The draft guidance, Safety of Nanomaterials in Cosmetic Products, was released 20 April and discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products. "Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured ...
  • Cosmetic Regulation Under Review in Congress

    The House Energy and Commerce Committee is slated to review the safety and regulation of cosmetics in a hearing scheduled for 27 March. The hearing intends to explore the possibility of establishing national standards for cosmetic ingredients, which the Committee writes "would serve to further public health by ensuring these decisions are made using sound science and ensure that the interstate flow of cosmetic products is not disrupted by differing State standards." "U...
  • Amidst European PIP Scandal, FDA Approves New Breast Implant Product

    The US Food and Drug Administration (FDA) approved Sientra, Inc.'s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US. The approval comes amidst a world-wide scandal about breast augmentation products manufactured by French company Poly Implant Prothese (PIP), which has been under fire for manufacturing implants using industrial grade silicone. PIP's products have also been the subject of concerns of abnorm...
  • British Surgeons Group Calls for Ban on Cosmetic Surgery Advertising

    • 23 January 2012
    A British Surgeons group is calling for the cessation of cosmetic surgery advertising in light of what it sees as "marketing gimmicks" that lead to unsafe and unnecessary surgeries. The President of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah told BBC news that "the many aggressive marketing gimmicks [not] only trivialize surgery but endanger the patient." Fatah further noted that patients are victim to "unrealistic expectations", "cras...