112TH CONGRESS, 1ST SESSION, H. R. 2359

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.

Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Ms. BALDWIN, Mr. MORAN, Ms. WOOLSEY, Mr. BLUMENAUER, Ms. CHU, Mr. GUTIERREZ, Ms. LEE of California, Mr. FRANK of Massachusetts, and Ms. WASSERMAN SCHULTZ) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

If this bill were to pass, small businesses would be unable to comply with even a fraction of what is required, because its overall impact, even with the exemptions, would cost them far more than any fee or registration requirement.  And I haven%u2019t even started discussing the adverse impact this bill would have on the consumers who have benefited so much from being able to choose handmade soap and cosmetics products made by American small and independent businesses.

Universal Flaws of SCA that Impact the Entire Cosmetic Industry

• Label Confusion:  There is no exemption for contaminants that occur in nature and appear in botanicals.  In addition, the process of writing a descending order label with all components and contaminants of every ingredient will require percentages of each to be known and merged like a Rubik%u2019s cube.  It will take a math whiz to accurately produce a correct label. 
  

• International Confusion: American made cosmetics will be completely out of step with the rest of the world and simply confused consumers.  
  

• Aromatherapy: All essential oils will be required to list constituents and contaminants making it impossible to recognize the essential oil used and wrongly alarming consumers. 
  

• Authoritative Source:  The Secretary and resources for safety information are less qualified to address the safety of cosmetic ingredients than the current CIR Panel.  This will cause confusion and the listing of ingredients never used in cosmetics and information unrelated to the topical use of ingredients.
  

• Duplication of Registration: In Sec 619 of the bill the manufacturer and distributor of a cosmetic are both required to have a registration number.  This would force even more layers of red-tape and expenses into the cost of cosmetics for consumers. 
  

• New wild, wild West:  Small businesses, and big, would all be at risk of the new wild, wild West created by this bill.  According to Sec. 620 ANY %u201Cresponsible party%u201D that has ANY %u201Creason to believe that a cosmetic%u201D is adulterated or misbranded by the definitions of this new legislation and has ANY reason to %u201Cpresent a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health effects or death to humans%u201D has the right to turn your into the Secretary. It will be your duty to defend yourself against ANY and ALL inaccurate %u201Cprobability%u201D that someone has that your product will cause %u201Cadverse health effects or death to humans%u201D despite the fact that no cosmetics EVER have.
  

• Adverse Health Effects:  The term adverse health effect is not clearly defined in the bill, despite being peppered throughout the language of the bill.  In reality an adverse health effect could be an allergic reaction, which given the range of allergies in the world would be impossible to avoid in one in a million people.

Impact of The Safe Cosmetics Act on Small Businesses {to name a few}

• Small businesses are exempt from registration and fees, but the costs of complying with the rest of the requirements of the bill will far outweigh theses costs.
  

• All small businesses, soapers and crafters would fall under %u201Cprofessional use%u201D and %u201Cvulnerable populations%u201D sections of the bill.
  

• Consumers would get the impression that the products of big businesses are safer than those from small businesses due to the difference in regulation.
  

• All businesses will be required to disclose their supply sources to the government rather than simply INCI names or CAS # of an ingredient.
  

• All finished cosmetics, whether from a big or small business, will require pre-market testing in order to comply with the parts per billion contaminant ingredient listing and MSDS creation.  The costs of pre-market testing for contaminants from ingredients, the combination of ingredients and packaging would be a barrier to entry for small businesses and put the majority of them out of business with the enactment of this bill.  In addition, all MSDS will be required to be available in any language and small businesses will bear the cost of producing those in all translations. 
  

• The bill requires that the Secretary send %u201Cnotification of failure%u201D to %u201Ceach known customer%u201D if the Secretary fails to act in time to a cosmetic or ingredient.  This would require small businesses to track their customers, even if they sell at a craft or farmers market.