Butler, Jennie C
From: MAILER-DAEMON@fw.fda.gov
Sent: Friday, May 14, 1999 9:28 AM
To: JBUTLER1@test.oc.fda.gov
Subject: Comments for 99N-0386

Submitter Information
Title - Mrs.
First Name - Betty
Last Name - Bridges
Organization Name - Fragranced Product Information Network
...

Stakeholder Responses to Questions

Question 1 - Utilize available technologies to take a more assertive role in ensuring the safety of products.

At present, in the area of cosmetics, the FDA takes somewhat of a passive role. Only when complaints or problems are brought to their attention in sufficient numbers is any action considered. At present the cosmetic industry, especially in the area of fragrances is self-regulated. Due to widespread use of fragranced products (and use of many of the same substances as flavors) there is considerable exposure via skin, ingestion, and inhalation. Utilizing available technologies the FDA needs to take a more assertive role in ensuring the safety of these products. Routine random analysis by gas chromatography would provide basic data on the composition of these products. This would better enable the FDA to monitor the safety and contents of such products, ensuring existing laws and safety standards are in compliance. Analyzed products should be evaluated for proper labeling, use of banned substances, compliance with good manufacturing practices, and compliance with safety standards of the industry.

Utilizing solid scientific technologies such as gas chromatography will enable the FDA to take an active role in ensuring the safety of products that are used on a daily basis. Analyzing as few as 10-15 products a year would provide scientific data to that could be used to work with industry to address health concerns and safety issues. It would put the FDA in a better position to ensure the safety products that are used on a daily basis. It would enable the FDA to make decisions based on scientific data.

Question 2 - Evaluate the long-term safety and health concerns of products.

The focus of safety testing of fragranced products has been effects on the skin such as allergy, irritancy, and photosensitivity. The skin is a route of entry into the body. In addition inhalation provides entry points for fragrance materials via both the lungs and olfactory pathways to the brain.

Fragrance materials accumulate in body tissues. Synthetic musk compounds are found in human fat tissue and breast milk. Fragrances are known triggers for asthma and upper respiratory problems such as sinusitis. Materials used in the past were found to serious neurological effects. Acetyl ethyl tetramethyl tetralin (AETT) was found to be severely neurotoxic and cause the internal organs of mice to turn blue. Musk ambrette was also found to be neurotoxic.

The life of a cosmetic can no longer be considered short term. The life of a fragrance is the lifetime of the user and beyond. The possible effects to the fetus and nursing child cannot be ignored.

Dr. Peter Spencer sums it up quite well in his testimony to Congress in 1986 on NEUROTOXINS: AT HOME AND THE WORKPLACE (Report 99-827)

NEUROTOXINS: AT HOME AND THE WORKPLACE

"Musk AETT(23) and Musk ambrette, two tested raw materials of the hundreds of untested chemicals used in fragrances and flavors have demonstrated potent neurotoxic effects and the capacity to induce the breakdown of nerve cells and myelin sheath in the brain, spinal cord, and peripheral nerves.(24) Countless other substances applied daily to the skin of consumers in the form of soaps, perfumes, aftershaves, and detergents have yet to be tested for their chronic neurotoxic effects."

"I would also add, because of my experience with regard to fragrance raw materials, that I would strongly suspect the American public would like to know what is applied to their skin voluntarily, and I suspect that they would be very troubled to learn that for 50 and 30 years respectively agents have been applied to skin voluntarily, often under the guise that they are in fact improving skin quality, but are able to penetrate the skin, and a recent experiments with animals caused devastating changes in the pervious system. I would like to add fragrances raw materials, some of which are food additives as well, to that list that Dr. Weiss offered"

Question 3 - Develop a comprehensive program for education, implement the program, and access its effectiveness. Modify the program as needed.

Points to be covered in program:

1. Ways of having input into the FDA
2. Provide information on all view points so the public will know the issues involved
3. Procedures and processes involved
4. Authority and limitations of authority of the FDA

Means to accomplish objectives:

1. Public service announcements
2. Utilize public education system to educate through the schools
3. Coordinate with industry, consumer groups, etc

Question 4 - Develop programs, which focus on long term effects of products used on a daily basis.

Products used on a daily basis provide the most exposure to the most people and have the most potential for long term effects. Since adverse effects are often not immediate, they are often overlooked or discounted. Additives to foods and cosmetic ingredients affect literally everyone, while they rarely get widespread publicity. The long term effects need to be determined

Question 5 - Further utilize the Internet to enhance communication

The Internet has provided a means of immediately sharing information. The FDA already utilizes this. The formats used in publicizing information and allowing input into the implementing the FDA Modernization Act should be expanded.

Many adverse reactions to foods, drugs, and cosmetics are never reported. Input via the Internet provides an easier way of reporting problems. Many people never report problems, as they may think the adverse affect is unique to them. Being able to view others comments will increase awareness. This will be especially useful in gathering data on adverse cosmetic and drug reactions.

Develop more "Fact Sheets" that provide concise information on topics that are of interest to the consumer.

Information and updates should be posted in a timely manner.

Question 6 -
By law the FDA's authority is limited in some areas. However, there are existing laws that are not fully utilized. Labeling laws for cosmetics is once such area. Though many ingredients in cosmetics and fragrances have not fully been tested for safety, there is no warning label on the products as required by law. Taking action utilizing the laws on labeling will ensure that the industry more fully tests their products or either correctly labels them. Consumers wrongly assume that products have been tested and are safe for use.

Proving a case of mislabeling takes much less resources than proving a product is damaging to health. Utilizing such existing laws will have the desired effect of making industry more accountable at less cost. The FDA must use innovative ways of making the best use of their limited resources in order to effectively protect public health. [Emphasis added. -- barb]

FDAMA 406(b) Objectives Selected

Fragranced Products Information Network (FPIN)
For information on health effects of fragrances, visit:
http://www.ameliaww.com/fpin/fpin.htm

Also see other comments by Ms. Bridges to the FDA:

• Stakeholders Meeting - Washington, DC - January 22, 1999
  http://www.cfsan.fda.gov/~dms/cos0199.html