With three cosmetics regulation bills now introduced in the US, here’s how the new Hatch bill stacks up against Feinstein-Collins and Sessions
On 25 October, Senator Orrin Hatch introduced a bill entitled the FDA Cosmetic Safety and Modernization Act.
Senator Hatch’s bill is the third bill introduced in this US Congressional Term that proposes to change the regulation of cosmetics in the US.
The other two bill are the Feinstein/Collins bill (S1113), also introduced into the Senate, and the Sessions bill (HR 575) introduced into the House.
So what does Hatch’s bill stand for and where does it fall short? Sharon Blinkoff, Counsel at Venable LLP and a supporter of the Sessions bill, shares her opinion.
“Senator Hatch was instrumental in creating the multibillion-dollar dietary supplement industry, which was supported by passage of Dietary Supplement Health and Education Act of 1994, a bill that Senator Hatch introduced and championed.
This bill helped advance the dietary supplement industry by limiting the FDA’s authority to regulate supplements as drugs and permitted supplements to make ‘structure function’ claims.
The approach taken by Senator Hatch in his new cosmetics bill is very different than that taken in the supplement legislation.
The new FDA Cosmetics Bill will impose additional requirements on the cosmetic Industry and will provide the FDA with enhanced regulatory authority over cosmetics.
The Hatch bill will require reporting to the FDA of serious adverse events involving use of cosmetic products.
The conditions which constitute serious adverse events are somewhat redundant and confusing, which may complicate reporting decisions, and since these conditions are not consistent with those established for reporting serious adverse events for OTC drug products, dual reporting may be required for combination OTC and cosmetic products.
Cosmetic labelling will, if the bill becomes law, require that product labels include a domestic US address and phone number or an Internet address for the responsible party (the party’s whose name appears on the product).
The bill, if passed, will require the responsible party to register with the FDA directly if the responsible party is the product manufacturer.
If the responsible party is not the manufacturer, the responsible party will be required to register their third-party manufacturers with the FDA.
Requiring responsible party marketers to register their manufacturers will significantly increase the marketer’s regulatory compliance burden especially when their manufacturer is a foreign manufacturer entity.
Beyond the enhanced regulatory compliance obligations, putting the onus on marketers to register their manufacturers will complicate FDA reporting systems, as there can be hundreds or even thousands of registrations for the same manufacturer.
Because the Hatch Bill requires responsible party marketers to maintain certain records, these marketers may also become subject to certain FDA inspections.
The Hatch bill also requires the FDA to adopt Current Good Manufacturing procedures for cosmetics and proposes to significantly increase the safety standards for cosmetics, from not presenting unreasonable risk of harm when used as directed to reasonable certainty that the product will not cause injury under ordinary conditions of use.
This translates into a very low risk tolerance which, in turn, will require much more powerful studies than those that are currently being conducted.
Probably the most troublesome provisions of the Hatch bill are the proposed changes to the enforcement sections of the current Food Drug and Cosmetic Act for that pertain to cosmetics.
The bill proposes to amend Section 601(a) of the act to dramatically reduce what the government has to prove in an enforcement action for adulteration –an enforcement action that carries criminal as well as civil penalties.
The bill also provides a new enforcement right whereby the Commissioner can (without instituting a formal legal proceeding) suspend a cosmetic manufacturing facility registration on two days’ notice if the Commissioner believes that one product manufactured at the facility has a reasonable probability of causing a serious adverse event.
These proposed changes would normally require a regulatory record like that shown for the Food Safety Amendments where thousands of serious adverse events and death were being caused by food carrying food borne illnesses.
Clearly cosmetics have not presented this level of risk. The issues and questions of safety that have arisen and are driving this legislative initiative have either been addressed or have not been yet been proven to have caused the alleged harm.
Cosmetic products have an excellent safety record, which have been supported by the industry through its successful self-regulatory programmes. The safety of the industry has been documented by the FDA’s records on experience reporting.
The other challenge in the US for the cosmetic industry has been the lack of national uniformity. While the EU moved to one national standard through adoption of the cosmetics directive, the US still permits the states to regulate cosmetic ingredient safety and to adopt other requirements for cosmetic products.
In fact, the only national standard for cosmetics are those which cover the mandatory labelling requirements established by the Federal Food Drug and Cosmetics Act and the Fair Packaging and Labeling Act.
The Hatch bill does address this lack of national uniformity in part by providing pre-emption for federal good manufacturing practices, the Federal Registration System and Adverse Event reporting requirements.
What the Hatch bill does not address is pre-emption of ingredient and product safety. In order to obtain national uniformity, there is a required ingredient-by-ingredient review.
Given the number of ingredients in use and the pace at which these can be reviewed, the Hatch bill does not provide a meaningful way to achieve national uniformity on ingredient and product safety.
What is proposed in the bill is permitting third-party reviews of these ingredients by private entities that are accredited by the FDA. This is not a practical solution to this problem from both a technical and legal perspective.
The Feinstein/Collins bill proposes this same ingredient-by-ingredient review, while the Sessions bill recognises the findings of existing scientific bodies and the findings of other FDA programmes on ingredient safety and review for cause if cause is presented.
The Sessions bill is more consistent with the EU approach by creating a National Standard on Passage.”
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