SAFETY INFORMATION SUMMARY PROGRAM GUIDELINE
The Program:
The purpose of the program is to provide a means for the U.S. Food and Drug Administration (FDA) to access proprietary information on cosmetic, toiletry, and fragrance formulations. In order to assure the availability of necessary information, companies should compile the following information on each individual formulation they market in the U.S. (except that formulations that change only by color may have a single compilation for all), and should make those compilations (Safety Information Summaries) available to FDA for inspection when requested as described below.
Safety Information Summary Contents:
- An identification code for each product using the formulation so that individual products can be related to the relevant formulation.
- The semi-quantitative formula for the formulation, using INCI nomenclature to identify the raw materials and providing their concentrations in ranges of >50%, 50 to >25%, 25 to >10%, 10 to >5%, 5 to >1%, 1 to >0.1%, and 0.1% or less.
- Raw material specifications, particularly considering limitations for possible impurities such as microbial flora, heavy metals, etc., and reference to the methods used to determine the specifications (or general discussions of the methods if they are not published).
- Finished product specifications, including limitations on microbial content, and reference to the methods used to determine the specifications (or general discussions of the methods if they are not published).
- A summary of the manufacturing process, which may be represented by a simple flow chart.
- A statement that the product has been manufactured under the good manufacturing principles as outlined in the Personal Care Products Council's (the Council) Quality Assurance Guidelines.
- A statement that the product's safety has been substantiated in accordance with the principles of the Council's Safety Testing Guidelines, and a summary of the elements that are the basis of the safety assessment, with appropriate citations.
- A computation of the incidence of adverse health effects in the United States (e.g., number per 100,000 or million units distributed) that have been medically confirmed as caused by the product in question. Minor, transient health effects need not be included in this computation.
Safety Information Summary Availability:
All of a company's relevant safety information summaries may be kept in one central location, in multiple locations, or may be a part of a database or databases from which a safety information summary can be readily assembled. Request for a particular safety information summary should be made by written request by the FDA District Director stating the basis for the request. The request should be made to the CEO, General Counsel or other official designated by the company to receive such requests. The request should specify the information the FDA is relying on to question the safety of the product, and must be based on a legitimate and specific safety concern or question related to a product, or ingredient in a product, manufactured by that company. The company should provide the safety information summary for inspection at a mutually agreed location within a reasonable time after receiving the request.
QUESTIONS AND ANSWERS - CONSUMER COMMITMENT CODE
1) What is the purpose of developing a Consumer Commitment Code?
The Code, which will reinforce existing company practices and introduce some new
practices, will go beyond the requirements of the law and highlight the proactive and
responsible approach to product safety supported by cosmetic companies. The Personal Care Products Council Board of Directors
unanimously approved the development of the Consumer Commitment Code to provide consumers, regulators and other
interested parties with a clear outline of the specific commitments by cosmetic companies to ensure the continued
safety of all cosmetic products.
2) Why is the industry adopting this new Consumer Commitment Code?
The safety of our products is the top priority of the cosmetic industry, and that priority is
reflected in our industry's long history of safe products. The Code will provide an even
greater degree of assurance of safety for consumers and transparency for government
regulators. It will reflect the safety practices many cosmetic companies have followed
for decades, and add new practices such as the Safety Information Summary Program.
3) Why did the industry decide to adopt a code at this point in time?
The industry decided to adopt this Code in the course of our constant review
of safety practices. We listened to the views of consumers, policymakers, and experts in our
industry as we developed the core elements of the Code.
4) Isn't product safety the responsibility of the U.S. Food and Drug Administration (FDA)?
Under current law and FDA's regulations, it is the industry's responsibility
to ensure that products and ingredients are safe before they are marketed. Toward that end,
the Council has supported a broad range of programs-many in cooperation with FDA-to ensure safety.
Cosmetic safety is regulated by the Federal Food, Drug and Cosmetic Act, and the FDA
is charged with enforcing that law. The FDA's Office of Cosmetics and Colors enforces
the law and establishes safety standards for cosmetics. In the unlikely event that an
unsafe product reaches the market, the law gives FDA the authority to ban or restrict
ingredients, to seek product recalls, to seize unsafe or misbranded products, to mandate
warning labels, and to prosecute violators.
5) Who will be asked to adhere to the Code?
Companies that manufacture or market cosmetic products or ingredients are encouraged
to acknowledge their support of the Code in writing beginning January 1, 2007.
6) What are the key elements of the Code?
- A company should use only ingredients that are substantiated for safety, either by findings of the Cosmetic Ingredient Review (CIR) Expert Panel and/or by data and information in the company's files that are available for inspection by FDA upon request;
- A company should provide FDA with the information on manufacturing establishments and ingredient usage called for by the Voluntary Cosmetic Reporting Program;
- A company should immediately inform the FDA of any serious and unexpected adverse experience from the use of a product marketed in the U. S.; and
- A company should maintain a Safety Information Summary related to product and ingredient safety that is available for inspection by FDA under specified circumstances.
7) Isn't this just an agreement to comply with existing law?
No. The Code goes beyond existing law by recommending (1) the reporting of serious
and unexpected adverse consumer experiences with cosmetic products, a current
requirement for prescription medicines; (2) the maintenance of a Safety Information
Summary on product and ingredient safety for products marketed in the US.; and (3) that
certain safety information be made available for inspection by the FDA.
8) When will the Code take effect?
The Personal Care Products Council members will be asked to provide written acknowledgment of the Code beginning
January 1, 2007. The Council has undertaken a broad educational program in 2006 and
continues to assist companies with understanding the substance of the Code. Because
we believe it is in the interest of every cosmetic company--the Council's member or not--to
ensure the safest possible products, we will reach out beyond our membership to other
companies in the industry and urge them to support the Code.
9) Does the Code offer legal advice?
No. The Code is not intended to be, nor should it be, construed as legal advice.
Companies have an independent obligation to ascertain that their marketing of cosmetic
products or ingredients complies with all current laws and regulations.
10) How will the Code be implemented?
Successful implementation of the Code is a top priority of the Council. Toward that end,
beginning January 1, 2007, when a company joins the Council or renews its membership, it
will provide a written statement acknowledging its recognition and support of the Code.
We will provide education and assistance programs to urge and assist everyone, whether
or not a Council member, to support this industry code.
The core elements of the Consumer Commitment Code were developed with the full
support of the industry. The Council's Board of Directors, whose companies represent the
majority of the cosmetic and personal care market in the U.S., unanimously approved
them in March 2006. Member companies already undertake many of the activities
required by the Code.
11) Will you terminate the Council's membership of a non-compliant member company?
We will not terminate the Council's membership for noncompliance. Rather than push
companies outside this system by terminating their membership, we will aggressively
work with them to encourage compliance. Industry leadership is committed to the Code,
and we believe every company will understand it is in their interest to support it. If they
need help doing so, we will provide it.
12) What does the new Safety Information Summary requirement of the Code entail?
A company should maintain information about its formulas, product testing, and adverse
consumer experiences with its cosmetic products for inspection by FDA officials under
specified circumstances when FDA has a specific concern about the safety of that
company's products. Maintenance of a safety information summary will provide FDA
with faster and easier access to this information, should a safety concern arise with a
company's product.
If the FDA determines a product is unsafe, it has extensive authority to take corrective
action, including seeking a recall, banning or restricting ingredients, seizing unsafe or
misbranded products, inspecting manufacturing facilities and even prosecuting violators.
13) How will cosmetic products manufactured outside the United States but sold in the U.S. be affected under the Code? Who will keep the safety information summaries in the U.S. for foreign manufacturers?
Companies that market their products in the United States should adhere to the principles
of the Code. Companies that operate in the U.S. will be asked to maintain safety
information summaries that will be available whenever requested by FDA officials.
14) In compiling a safety information summary, is a company expected to conduct new research on each product and ingredient?
Not necessarily. While there are situations in which additional scientific research may be
necessary, companies may resolve safety issues using appropriate existing scientific data,
data available for similar ingredients, toxicity profiles of the products and ingredients,
and the larger body of relevant scientific literature.
15) What other self-regulatory programs does the industry have in place to ensure cosmetic safety?
The industry has, since 1976, supported the existence of an independent scientific body
called the Cosmetic Ingredient Review (CIR) Expert Panel. CIR reviews the safety of
cosmetic ingredients in a public process that prioritizes ingredients for review based on
several factors, including how widely they are used and their potential to pose a risk to
consumers. CIR's Expert Panel is made up of world class scientific experts who meet the
same conflict of interest standards as do members of FDA advisory committees.
Representatives of the FDA, the Consumer Federation of America and the industry sit as
liaison members of CIR's Expert Panel. CIR's ongoing review has evaluated 1,285
ingredients to date, and its integrity and effectiveness have been praised by several FDA
Commissioners over the three decades of its existence.
