Read the entire bill here. (47 pages)
This bill is intended to amend the Federal Food, Drug and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.
IF the bill passed in this format, this is what if would mean for your business:
Who does this bill affect?
Any establishment located in any state that manufactures, packages or distributes cosmetics.
Any foreign establishment that exports cosmetics to the United States without further processing or packaging outside the United States.
How will it affect your business?
Any establishment as defined above will have to register with the Secretary (the FDA) by providing the following information:
- Trade Names
- Description of Activities
- Number of Workers Employed
- Gross receipt of Sales
- Names and Addresses of any suppliers of ingredients
Any changes to the registration will be made within 60 days.
Once the registration is completed the establishment will be assigned a registration number.
The FDA will maintain a list of establishments that are registered and this list will become public information.
Any establishment that fails to provide complete information of fails to register will be removed or suspended.
(Currently the FDA has a Voluntary Cosmetic Registration Program (VCRP) this bill would make registration mandatory and require further information).
A fee schedule will be determined by the FDA. All companies with annual gross receipts of less than $1M will not be assessed a fee.
(Although the fees will not directly affect you, it may affect your suppliers or their suppliers and will have a trickle down affect to the end user).
All products will be labeled with the name of each ingredient in descending order of predominance. A contaminant or trace element is not required to be listed if the contaminant is present at levels below technically feasible detection limits.
All products sold in e-Commerce will now be required to have an ingredient list on the website as well as the product label. This includes the establishment’s website as well as the websites of their distributors.
List of Ingredients
The FDA will keep a list of ingredients that are prohibited or restricted for use in cosmetics and continually update that list. The list will be ingredients that are known to be carcinogenic, mutagenic, or have reproductive and developmental toxicity, based on information from the following:
- The Environmental Protection Agency
- The International Agency for Research on Cancer
- The National Toxicity Program through the National Institutes of Health
- The California Environmental Protection Agency
- Other authoritative international, Federal, and State entities (as determined by the Secretary)
(It will be the responsibility of the manufacturer to keep up with what is on the list and what is added to the list, at this time it is not clear how this list will be maintained and in what format).
Eighteen months after the date of enactment of the Act, each manufacturer shall submit a statement signed by the CEO, based on available information after a good faith inquiry, that -
- The cosmetic and its ingredients meet the safety standard; or
- There is insufficient data to determine whether the cosmetic and its ingredients meet the safety standard.
(This will be done for each product that you sell, it is not clear what is done in the case of a product that has insufficient data).
Registration of Products
Each manufacturer shall submit electronically each cosmetic manufactured in the establishment that is intended to be marketed in the United States a statement containing:
- The registration number of the manufacturing establishment.
- The registration number of the establishment responsible for distributing the cosmetic.
- The brand name and the product name for the cosmetic.
- The applicable use for the cosmetic.
- The ingredient list as it appears on the cosmetic label of insert, including the particle size of any nanoscale cosmetic ingredients.
- Any warnings and directions for use from the cosmetic label or insert; and
- The title and full contact information for the individual responsible for submitting and maintaining such statements.
Any changes will be made in a timely manner and notification will be made to the Secretary.
Each statement will be assigned a cosmetic statement number by the Secretary upon submission.
(This means EVERY product that you manufacture and market to the public which will limit your ability to change and try new products on short notice).
Reporting of Adverse Health Effects
All reports of adverse health effects shall be made within 15 business days of the event.
The content of the report shall include:
- An identifiable patient.
- An identifiable report.
- A suspect cosmetic.
- A serious and unexpected adverse event.
All information submitted to the Secretary shall be deemed public information and nonconfidential with the exception of the concentration of cosmetic ingredients used in a finished cosmetic.
At the 2010 Annual Meeting in Denver, Colorado, the membership passed a legislative advocacy statement:
“The position of The Handcrafted Soapmakers Guild is to act as an advocate in all areas that affect the manufacture, sale and distribution of handcrafted soap as defined by HSMG Policy 2005-04-28 Position Statement. Handcrafted soap under these definitions can be either a soap or a cosmetic depending upon how it’s formulated and labeled.”
The FDA’s website has a page with a very good definition of whether your soap is a soap or a cosmetic. To re-educate yourself click here.
It is the position of the HSMG that H.R. 5786, The Safe Cosmetics Act of 2010
- Is poorly written and confusing.
- Places too much of a financial burden on small business.
- Over regulates an already safe industry.
- Destroys the creativity and flexibility of small handcrafted soap manufacturers.
- Creates further job loss and loss of local revenue in already tough economic times.
Therefore, the HSMG is against H.R. 5786 The Safe Cosmetics Act of 2010 as written.