Tuesday, April 3, 2012
HR 4262: The Cosmetics Safety Enhancement Act of 2012
Not much has been said about this new bill, possibly for two reasons: the Campaign for Safe Cosmetics is apparently not behind it, and because the language of the bill is so hard to understand that it seems to require a lawyer to interpret. This bill also is not exactly a new bill but rather an amendment to the current Federal Food, Drug, and Cosmetic Act. You can read the entire bill here: http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.4262:
Here are some of the highlights of the bill and my commentary.
Registration and Fees
HR 4262 requires all manufacturers (facilities) to be registered with the FDA. I do support registration. It is an important means for communication between the FDA and businesses so that the latest information on safe ingredients and processes can be brought to businesses. However, this bill also requires registration of every product that is manufactured and all the ingredients used as well as their sources. The paperwork involved here would be devastating for small, individually owned businesses that typically do not have employees. The registration process also requires a registration fee of $500 minimum, annually, making starting a small business more difficult.
Good Manufacturing Practices
Currently the FDA has a published guide to good manufacturing practices. You can find these here: http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/goodmanufacturingpracticegmpguidelinesinspectionchecklist/default.htm
While I do of course support good manufacturing practices that would ensure safe cosmetics, many of the current recommendations are not friendly to small businesses. For instance “Weighing and measuring of raw materials is checked by a second person.” Most small businesses do not have a second person available to double check their work so one person businesses would not be allowed. And some statements are quite vague and cannot be interpreted such as “Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.” Any rewriting and enforcement of GMP needs to take small business practices into account, many of which are making product in their kitchens.
Serious Adverse Effect Reporting
Having a way to report serious, adverse events that occur with the use of cosmetics is a must. In this new bill a business must report to the FDA any information received concerning serious adverse events. These are defined as death, life-threatening experience, inpatient hospitalization, disability, disfigurement or incapacity, congenital anomaly or birth defect, or an event requiring medical or surgical treatment.
Section 605 of this bill says: “(2) demonstrate that such cosmetic product is safe”. Without giving any detail as to what kind of information the FDA would be looking for to demonstrate safety leaves this section completely open to interpretation. The question is, who would interpret it? This concerns me the most and is much different from previous forms of this bill where the responsibility to prove safety was placed on ingredient manufacturers rather than on the individual who makes the cosmetic product. Safety information might include:
- bacterial or animal testing to show mutagenicity
- animal studies on carcinogenicity
- Draize test for eye sensitivity
- analytical testing for trace minerals (lead, arsenic,mercury)
- skin patch testing for sensitivity
- testing for estrogenic activity/ fish toxicity testing
- microbiology testing for contamination
As a small business, are you prepared to do any of these tests? I’d like to see some specifics here as to what information is required to substantiate safety of a finished product.
Mandatory Recall Authority
Section 608 gives the FDA the authority to recall a cosmetic product that is deemed adulterated if its use would cause serious adverse health consequences. Authority to recall a product to prevent death is always good and the FDA does have this authority with food. Currently companies voluntarily recall any cosmetics products that have been found adulterated such as those that have been found to have high concentrations of potentially harmful bacteria or fungus. This volunteer method has worked well, but there is no harm that I see in making it mandatory.
Unlike previous proposals, this bill does not address safety of individual ingredients but rather just requires that the final cosmetic product be proven safe. Not knowing what would be required here would most likely put more pressure on the small business owner. It also does not ask for full disclosure of ingredients. Important oversights in this bill are allowances for small business and a preemption to prevent states from individually requiring stricter cosmetic laws. If each state has different laws that govern cosmetics, commerce would be stifled.
The Personal Care Products Council (PCPC) has suggested in the past that they would introduce legislation, but as far as I know they have not done so. Through its experts, the Council has offered the following specific provisions for Congress to consider when drafting legislation which would bolster FDA’s oversight:
1. Enacting into law the existing FDA voluntary programs for registration of manufacturing establishments and listing of cosmetic products and their ingredients.
2. Requiring submission of reports on adverse reactions that are serious and unexpected.
3. Mandating FDA regulations establishing Good Manufacturing Practices (GMPs) for cosmetics.
4. Establishing programs to require FDA to review and determine the safety of cosmetic ingredients and constituents along with strong FDA enforcement.
5. Requiring FDA review of all CIR determinations on cosmetic ingredient safety and either accept or reject those determinations.
6. FDA establishment of a national cosmetic regulatory databank for use by other state authorities and the public.
7. An unambiguous Congressional determination that, as modernized, the revised statute will apply uniformly across the country.
“Our industry supports these important reforms and encourages Congress to act on them,” said Lezlee Westine, Council President and CEO. “We are requesting comprehensive, mandatory regulation and our rationale for that is simple: it is in the best interest of regulators, manufacturers and consumers – all of whom will greatly benefit for years to come.” You can read more about that here: http://www.personalcarecouncil.org/newsroom/20120327
Unfortunately, the PCPC also does not ask for accommodations for small businesses.
Read more commentary on this bill here:
Donna Marie of Indie Business:
Forbes article by Amy Westervelt:
Lela Barker of Bella Lucce:
If you’ve read this legislation, what do you think?