November 16, 2011
Ms. Lisa Archer
Director, Campaign for Safe Cosmetics
c/o Breast Cancer Fund
1388 Sutter Street #400
San Francisco, CA 94109
Dear Ms. Archer,
Our Chairman and CEO, Bill Weldon, asked me to respond to your letter on his behalf, as I am responsible for product stewardship at Johnson & Johnson Consumer Companies. You and I have had several discussions over the past two years, so I think you know that our commitment to ensuring the safety of personal care products, especially those for babies, is at the core of everything we do and who we are as a company. For over 100 years, mothers, fathers and caregivers have relied on us to care for babies and children, and we work every day to maintain that trust. While we would still disagree with the science and conclusions in your letter and report, we want you and those who count on our products every day to understand our commitment to safety, as well as some of the steps we are taking that go beyond considerations of safety alone to respond to changing consumer needs and values.
When we develop a personal care product, our experts including doctors, toxicologists and biologists, carefully review safety data and the most recent scientific literature on the ingredients, and we thoroughly evaluate all our finished formulations for safety. We understand that babies' skin, hair, and eyes are different from adults' and we develop our products with this in mind, consulting with pediatricians, nurses and other professionals to ensure that all our baby products are safe, mild and gentle. In addition to our own high standards, our products always meet -- and often exceed -- the standards of the agencies around the world responsible for the safety of personal care products in the markets where they are sold.
In your letter, you raised a question about repeated exposure to traces or ingredients. I want you to know that our standards assume repeated exposures, which is why we set very conservative limits when formulating our baby products. For example, the level of exposure to formaldehyde, released in tiny amounts by certain preservatives to keep the products safe from contamination by bacteria, is about the same in an entire bottle of baby shampoo as a person would be exposed to by eating an apple or pear, in which it occurs naturally. I also want to point out that our own extensive research and the vast majority of published scientific research indicates that these preservatives are safe and mild, and they have been extensively studied and continue to be supported by regulatory agencies around the world, including the U.S. and European Union. It is disappointing that your report did not provide this kind of perspective, since it probably caused parents undue alarm.
Parents can rest assured that every JOHNSON'S® product they use today is safe. But we understand that the bond of trust we have with the people who use our products often means going beyond safety alone. We listen to consumers, and respond to their needs and values, and their desire for products that are more sustainable and gentle on both people and the environment. We are continually making changes as we seek the next generation of pure, mild and gentle ingredients that parents can continue to use with complete confidence and peace of mind. Over the years, we have gone beyond considerations of safety alone in introducing a number of changes to JOHNSON'S® Baby products that I know you'll be interested in.
For example, last year we completed the removal of phthalates, including phthalates in fragrances, from our baby products. We also have begun providing new formulas with alternatives to formaldehyde-releasing preservatives and expect to finish this process in our hundreds of baby products around the world within about two years, and sooner for our baby shampoos. We also are well along in work with our global suppliers to require them to use state-of-the-art technologies that reliably reduce traces of 1,4-dioxane to <1 to 4ppm, and most now meet this standard. Even as we complete this changeover, we continue to search for new alternatives that do not produce 1,4-dioxane during the manufacturing process, and this is our long-term goal.
In your letter, you also raise the issue of disclosure of fragrance ingredients. We and other companies are engaged in discussions with many stakeholders to better understand different points of view, and we are happy to discuss the issue further with you. Working together with others, we believe we all will be able to find solutions that meet the needs of consumers, and we will continue to work to find those solutions.
We believe that it is important to keep the people who rely on our products informed, which is why we've shared the points in this letter on our JOHNSON'S® Baby website, along with more information about the steps we take to ensure that they can continue to use JOHNSON'S® products with complete confidence in their safety.
Vice President, Product Stewardship & Toxicology
November 1, 2011
A Statement on Ingredients in the News
At JOHNSON'S®, what's most important to us is the bond of trust we have with the parents and others who rely on us to care for their families. Most parents already know that the ingredients in our JOHNSON'S® Baby products meet and often exceed the government safety standards for every country and market in which we operate. In addition, our team of physicians and scientists constantly monitor the best available science to make decisions about the formulations of our products.
So you can be assured that every JOHNSON'S® product is safe. But that's only the beginning. We understand that trust sometimes means going beyond safety alone. That's why we are continually improving our products to contain purer, milder and gentler ingredients that parents can use with complete confidence and peace of mind.
Among the steps we're taking to go beyond just safety alone are:
- We have been phasing out the use of preservatives that release tiny amounts of formaldehyde to guard against bacterial contamination. These preservative technologies, which are used widely in our industry are all safe and approved in the countries where they are sold. Going beyond safety alone, to meet the changing needs and expectations of parents, we are no longer introducing new baby products that contain these types of preservatives. Over the past couple of years, we already have reduced the number of formulations globally with these "formaldehyde releaser" preservatives by 33% and in the U.S. by over 60%. We are completing this reformulation as quickly as we can safely and responsibly do so.
- As part of the manufacturing process, we have extensive monitoring to ensure that the amount of a trace byproduct known as "1,4 dioxane" in any of our products is well below the level that the U.S. Food and Drug Administration and regulatory agencies around the world consider safe. In addition, we already have reformulated approximately 70% of our baby products with new cleansing formulations that further reduce these traces to below reliably detectable levels, and are continuing to reformulate. We also continue to search for new technologies that will eliminate 1,4 dioxane from the manufacturing process altogether.
- We have introduced new product formulations for consumers who prefer natural products, such as JOHNSON'S® NATURAL®, a line that is 98% natural, and contains no formaldehyde releasing preservatives or traces of 1,4 dioxane. JOHNSON'S® NATURAL® is priced considerably below "boutique" natural baby products, and puts an all-natural line within the budget of most consumers.
How We Ensure the Safety of our Baby Products
At the Johnson & Johnson Family of Consumer Companies, we want every baby around the world to have the very best start in life. Our promise is to consistently deliver pure, mild and gentle products that are safe. We value the trust that parents and professionals have placed in us for over 100 years, and work every day to maintain that trust.
OUR STANDARDS: We set and hold ourselves to high quality standards. We have an ongoing commitment to research and development and employ hundreds of scientists around the world. We take a rigorous approach to ingredient selection for all our products. All ingredients and their safety data, as well as data from external scientific authorities, are reviewed by experts (MD's, toxicologists and/or biologists) prior to use in a product, and all final formulations are evaluated for safety prior to launch. Ingredients are also assessed for their environmental impact. All of our products meet or exceed the regulatory standards of the countries in which they are sold. We do extensive safety evaluation and testing. We voluntarily submit all our formulas to the US FDA on an annual basis, and make all our safety information available for inspection by the FDA. We have a Quality Assurance group that audits each and every facility where we manufacture our products to make sure our strict manufacturing and quality requirements are met.
ONGOING EVALUATION OF INGREDIENTS: We only use ingredients with proven safety and performance. We have a global ingredient policy team that regularly reviews emerging data and stakeholder concerns on all the ingredients we use. If new scientific data raises credible questions about the safety of an existing ingredient, we apply a precautionary approach and appropriately restrict or eliminate its use. We also seek to minimize or eliminate the use of ingredients that are of concern to consumers in a way that continues to meet our rigorous standards for safety. For example, we reformulated our baby products worldwide to be free of phthalates. We also have a commitment to innovation which includes a focus on identifying and developing the next generation of ingredients using green chemistry principles.
SCIENCE and PROFESSIONAL PARTNERSHIP: We have strong partnerships with professionals around the world. We work with maternity hospitals, pediatric review boards, outside scientists and experts to help strengthen our scientific understanding of what is best for baby's care. Our regular, ongoing dialogue with pediatric dermatologists, pediatricians, midwives, and nurses helps guide our new product development process.
ENVIRONMENT: We continuously work to reduce our environmental impact. For the past 10 years, we have used a Design for the Environment tool to assess the environmental impact of all our ingredients. As this tool was designed to assure the safety of industrial chemicals, we recognized that it was not discriminating enough for the relatively benign materials used in our products, so we worked with external experts to develop a proprietary advanced screening tool which assures that we are continually using more environmentally benign materials. We are also active in working with industry groups, thought leaders, regulators, and the US EPA on advancing the principles of green chemistry.
For more than 100 years, Johnson & Johnson Family of Consumer Companies have been providing parents with safe and effective products for their babies and young children. Our goal is to go beyond safety alone, to provide parents and their babies with pure, mild, and gentle, products that they can trust and use with confidence.