Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.

Registration in California
In October 2005, California governor Arnold Schwarzenegger signed the Safe Cosmetics Act (SB 484) into law; for a detailed review of this act, read the October 2005 and February 2006 “Regulatory Review” columns.1, 2

On Jan. 1, 2007, as a first part of the California Safe Cosmetics Program, the law required manufacturers of cosmetic products sold in California and subject to FDA regulation to provide the state with a list of products containing ingredients it deems to potentially cause cancer or reproductive toxicity. These ingredients include fragrance chemicals or those given trade secret status by the FDA. In accordance with this state Act, the definition of a manufacturer is the company named on the cosmetic product label; in contrast, ingredients are defined by federal regulation (FDA 21CFR700.3).

The law also declared the National Toxicology Report on Carcinogens, the International Agency for Research in Cancer, the US Environmental Protection Agency, and the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction as the authoritative bodies responsible for classifying chemicals as carcinogens or as toxic to reproductive health. The law did not include the California Office of Environmental Hazard Health Assessment (OEHHA), which promulgates the California Proposition 65 list of chemicals deemed to cause cancer or reproductive toxicity. In addition, this law did not apply to companies whose sales were less than US$1 million, according to their tax returns.

While manufacturers were expected to report their products in 2007, they were unable to comply since they did not have the necessary forms or methods to submit; such means did not become available until June 15, 2009. Now that the forms are available, the deadline to submit is Oct. 15, 2009, and all manufacturers of products launched since Jan. 1, 2007, are expected to comply. Article 1 Section 9 of the US Constitution prohibits this, considering it ex post facto.

After manufacturers were required in 2007 to report their products to the California Division of Environmental and Occupational Disease Control (DEODC), also referred to as the Division, the DEODC could conduct an investigation to review: health effect data and studies; work site health hazard evaluations; epidemiological studies to determine health effects of exposure to chemicals in various subpopulations; and exposure assessments to determine total exposures. The DEODC may require manufacturers to submit relevant health effects and studies, and other information such as concentration in the product, or the amount, volume or weight of the product that comprises the average daily exposure. Within 180 days of receiving the results of this investigation, the DEODC must then develop and present one or more proposed occupational health standards.

The second part of The Safe Cosmetics Act requires the DEODC to investigate cosmetic products that contain unsafe ingredients according to the Cosmetic Ingredient Review (CIR). If these products do not have a warning on their label stating that their safety has not been determined (21CFR700.10), the DEODC must determine if the product’s safety has been adequately substantiated and whether the product contains an unsafe ingredient. The results of this investigation are then reported to the US Attorney General and the FDA for enforcement action.

How to Register
It took nearly two and a half years but California finally issued instructions for manufacturers to report their products and thus comply with this act. Filing for the California Safe Cosmetics Program must be conducted electronically, and complete information, including the forms, may be obtained online.1 The information presented here is the main steps and is intended to serve as an overview.

Who must file: The party responsible for filing is the company whose name and address appears on the label. This task can be delegated to the manufacturer or even a third party (e.g., a consultant). If a third party is utilized, a written agreement should be drawn up outlining all possible costs involved. Companies that do not own the product formulations may want to consider this approach, especially if the owner of the formulation does not wish to disclose detailed information to the customer; third parties can discretely disclose the necessary information to the state.

Requirements: Companies must report whether they sell products in California and if they have realized more than $1 million in global sales for the previous tax year. Products reported should contain one or more ingredients in their list; this excludes trace contaminates and only applies to ingredients included in the product. All the components of purchased mixtures are considered ingredients, including flavors and fragrances (see below). Products submitted must meet the FDA definition of a cosmetic or cosmetic/drug. Products exempted include FDA-exempted soap and drugs that make no cosmetic claims. Private label companies selling the same product to multiple companies may file once on behalf of all parties.

Flavors and fragrances: If a chemical on the ingredient disclosure list is part of a fragrance or flavor, the state requires manufacturers to register it under the law as they would any other chemical on the list. Manufacturers will need confirmation and the amount of each such chemical from the supplier company. The only chemical on the list that can be used in flavors and fragrances is acetaldehyde.

Instructions and definitions: Definitions2 and instructions3 can be found online. Generally, information that should be submitted includes: the name of the company and any other names under which the company conducts business; the corporation name; the company’s Web site; indication of whether the company is public or private; the company’s business address; representation of how the company is labeled on the product; the company’s contact information; the submitter’s information; the name of the product; the brand name; the name of the manufacturer; the product’s intended use; the list of chemicals that require reporting; and the concentration of the chemicals in the finished product. This represents a challenge, especially for ingredients like titanium dioxide. Pure titanium dioxide is never used and is not an item of commerce. Nano-sized (if they exist) and micro-sized pigments typically have stabilizers and occasionally coatings. These stabilizers often are closely guarded trade secrets and nearly impossible to identify. What is the submitter to do in such cases? Lie and report the amount the manufacturer included? Perhaps it is better to overestimate than underestimate.

Chemicals that must be filed: If a manufacturer has used any of the chemicals listed as potentially causing cancer or reproductive toxicity, the products containing them must be reported. This list4 consists of 783 chemicals; however, the most common ingredients found in cosmetics include: butylated hydroxyanisole (BHA), which is on the Prop 65 list but rarely used; black 2 or carbon black, an FDA batch-certified color; cocamide DEA; methyl alcohol, since it is a denaturant in SD alcohol 1, 3-A, 30; retinol and retinyl esters, with the most common being acetate and palmitate; and titanium dioxide. Less common cosmetic ingredients include: acetaldehyde, used in fragrances; 4-amino-2-nitrophenol, used in hair dyes; prycatechol; dibutyl phthalate; ethyl acrylate; glycol, known by its chemical name ethylene glycol; formaldehyde, but only as the anhydrous gas; lead acetate; spironlactone; sulindac; talc that contains asbestiform fibers; and toluene, previously found in nail polishes.

Creating an account: Accounts, user names and passwords can be obtained online.5 After this information is obtained, the account holder may log in and fill out the form. Instructions are provided on Pages 12–27.6

California has finally released the forms needed for manufacturers to comply with the California Safe Cosmetics Program. It also has published the list of chemicals that, if used in cosmetic products, require registration with the state.

In addition, the definition of a cosmetic was changed by California lawmakers to include drugs that make cosmetic claims. This author is now wondering if drugs making cosmetic claims are thus regulated as cosmetics in California. To this end, will these products no longer require FDA OTC monographs, and can they use any UV filter they desire?

Instead of carefully reviewing existing lists of chemicals published by various organizations, California included all of them without considering the fact that the vast majority of these chemicals have never been used in cosmetics and may or may not cause cancer or reproductive toxicity. Those directed to come up with a list of ingredients simply aggregated a large list, which is likely to scare consumers.

In fact, California has relied on a study by the Environmental Working Group stating that 54 cosmetic products contain ingredients that the CIR has deemed as unsafe. This is the same group that gave titanium dioxide its safest rating, when according to the International Agency for Research on Cancer, this ingredient is found to cause cancer. How much money will be wasted to locate these “unsafe” products? California should save its money; these 54 products are not sold in the United States, much less in California.

As an aside, California is in such a poor fiscal position that the office administering this program has mandated closings for three Fridays each month until 2010—yet it is willing to bleed precious dollars on something of zero value. There is nothing in this law that will make cosmetics safe. Cosmetics are already required by federal law to be safe but California is attempting to make them safer than safe, which makes little sense. While the governor should not have signed such a bill, it was also the media’s responsibility to expose the silliness of such legislation.

Electronic-only Drug Registering
Effective June 1, 2009, the FDA no longer accepts drug establishment registrations or drug listing information in paper form unless a waiver is granted. The same forms are required; however, they now are only accepted electronically.

Previously, manufacturers of drugs, including OTC drugs such as sunscreens, were annually required to file FDA form 2656, known as the Registration of Drug Establishment/Labeler Code Assignment. Now online, this form is required to be submitted once per manufacturer. A second form, FDA-2657 or the Drug Product Listing, is required for each drug registered. The FDA-2657 must be filed for each formulation and is also used to file updates in June and December, or at the discretion of the registrant when any change occurs. A third form, FDA-2658 or the Registered Establishments’Report of Private Label Distributors, is required when the drug is not made by the manufacturer.

For those filing FDA-2658, the labeler code from FDA-2656 will be required. Like FDA-2657, this form is also used to file updates in June and December, or at the discretion of the registrant when any change occurs.

Manufacturers outside of the United States wishing to register a drug with FDA-2657 must first submit FDA-2656 and include a signed letter designating their representative US address. This letter designates a US liaison address for communications with the FDA and will provide non-US manufacturers with a labeler code. After this address is established, the FDA will send all notifications, communications and infractions to that address. Non-US manufacturers may use distributors, lawyers or consultatants for this purpose; however, the manufacturer should be aware that sales agents at distribution centers may not be able to answer the FDA’s questions.

Complete information for filing electronically can be found online,5 as well as guidance information and the electronic submission gateway. Those companies filing will need a gateway account and a DUNS number—a nine-digit account number that identifies an organization.

Although the system to electronically register drugs with the FDA sounds easy, it is not. As of press, this author was unaware of anyone able to successfully register due to the system’s convoluted instructions. Since the system currently serves as a roadblock to filing and it is the only filing method accepted, it will likely lead to more noncompliance. This system should have been tested before it was released to the industry.

From what can be understood from this new system, what was once free is now subject to user fees. If anyone has successfully used this system, please share your knowledge. Many in the industry are willing to learn the process.

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Send e-mail to [email protected].
1. DC Steinberg, California Revisited, Cosm Toil 120(10) 52–60 (2005)
2. DC Steinberg, Debunking California’s Law, Cosm Toil 121(2) 32–36 (2006)
3. California Safe Cosmetics Program, available at (accessed Jul 30, 2009)
4. California Safe Cosmetics Program Informational Sheet Definitions, available at (accessed Jul 30, 2009)
5. Instructions for the California Safe Cosmetics Program Reporting System, available at Jul 30, 2009)
6. Chemicals Known or Suspected to Cause Cancer or Reproductive Toxicity, available at (accessed Jul 30, 2009)
7. California Safe Cosmetics Program Reporting System, available at (accessed Jul 30, 2009) 8. Electronic Drug Registration and Listing Instructions, available at (accessed Aug 12, 2009)

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