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Bipartisan bill introduced to expand FDA’s authority over cosmetic products.

  • Although FDA currently has authority to regulate cosmetic products marketed in the United States, regulatory action in this space has been dormant for decades.  Unlike with other product categories, FDA lacks mandatory recall authority for cosmetics and manufacturers are not required to disclose adverse health effects reported by consumers.
  • In April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act, intended to expand FDA’s regulatory authority over cosmetic products.  Cosmetic manufacturers (including ingredient manufacturers) would be subject to a facility registration requirement and would be required to pay a registration fee based on the registrant’s average gross annual sales in the United States.  FDA would have mandatory recall authority over cosmetics where exposure to such products is likely to cause serious adverse health consequences or death.  Under the bill, cosmetic companies also would be required to report “serious” adverse health events (e.g., resulting in death, disfigurement, or hospitalization) reported by consumers within 15 business days.  Cosmetic labels would need to include a domestic phone number or electronic contact information.  The bill also proposes to require FDA to issue regulations on good manufacturing practices (GMPs) for cosmetics and to review the safety of at least five different cosmetic ingredients each year.  The first candidates for a safety review would be:  (1) diazolidinyl urea (formaldehyde-releasing preservative); (2) lead acetate (color additive in men’s hair dye); (3) methylene glycol/methanediol/formaldehyde (formaldehyde-releasing chemical used in hair-straightening treatments); (4) propyl paraben (preservative); and (5) quaternium-15 (formaldehyde-releasing preservative).  Each of these ingredients has been subject to varying degrees of consumer concern and controversy in recent years.
  • The bill is supported by diverse stakeholders including members of the cosmetics industry and the advocacy group, Environmental Working Group (EWG).  Although this bill is not the first attempt to reform FDA’s regulation of cosmetics, it is the most comprehensive.  Particularly considering the support this bill has garnered from both sides of the aisle, as well as industry and consumer advocates, it potentially could be the most promising reform effort to date.

Senators criticize FDA for inadequate pet protections.

  • FDA oversees the safety of animal feed and pet food in the U.S.  Due to some idiosyncrasies in the animal food regulatory framework, FDA shares its pet food oversight responsibilities with state regulatory officials and the Association of American Feed Control Officials (AAFCO).  FDA has been tasked with implementing specific pet protection measures under the Food and Drug Administration Amendments Act of 2007 (FDAAA).  Enacted in response to the largest pet food recall in U.S. history (linked to melamine-contaminated ingredients from China), Title X of the FDAAA required FDA to establish standards for pet food ingredients and processing, to create an early warning and surveillance system to track outbreaks of illness associated with pet food, and to provide for better communications during pet food recalls.  Thus far, FDA has largely failed to implement these requirements.
  • Senators Dianne Feinstein (D-CA) and Richard Durbin (D-IL) recently sent a letter to FDA Commissioner, Margaret Hamburg, criticizing the Agency’s failure to take enforcement action related to recent reports alleging toxicity of a major pet food manufacturer’s product line,  The Senators also criticized FDA’s failure to implement its FDAAA pet protection mandates more generally.
  • The Senators’ letter is dated March 11, 2015.  On March 27, 2015, FDA announced its new strategy to standardize animal food ingredients in accordance with its FDAAA mandate.  Although FDA’s strategy likely has been under development for some time, the timing of the Agency’s announcement relative to the Senators’ letter raises questions about whether political pressure will finally spur FDA to act on its other long-overdue pet protection mandates.

Family sues over caffeine-related death.

  • On March 6, 2015, the family of Logan Stiner, an Ohio teenager who died from cardiac arrhythmia and cardiac arrest after consuming pure powdered caffeine, filed a wrongful death suit under the Ohio Food & Drug Safety Act.  The suit names as defendants Amazon.com, six other companies involved in manufacturing, marketing, distributing and selling the product, and Logan’s high school classmate, who allegedly supplied him with the caffeine powder.  Following Stiner’s death, FDA posted a consumer advisory warning of the dangers of consuming powdered pure caffeine.
  • According to the complaint, the pure caffeine powder was “unsafe and dangerous” and the companies “knew or should have known” that the product at issue was “dangerous, or likely to be dangerous when used in a reasonably foreseeable manner.”  The complaint alleges that the product is a misbranded drug, based on, among other things, the listing of pure caffeine in the U.S. Pharmacopeial Convention (USP) and further alleges that the defendants “have successfully avoided meaningful regulation of [their] product by the U.S. Food and Drug Administration (FDA) by classifying their product as a ‘dietary supplement.'”
  • The case underscores the responsibilities businesses involved in manufacturing, marketing, distributing, or selling products have to ensure their products are safe when used in a reasonable foreseeable manner.  Regulatory and product liability risks are greatest for products that arguably meet the definition of “drug” under Section 201(g)(1) of the Food, Drug, and Cosmetic Act but are marketed as dietary supplements, conventional foods, medical foods, or cosmetics and are therefore not subject to FDA approval.

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