Talc Kills - We Demand FDA ACT!
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Rosemary Yuhasz Chatham started this petition to United States Food and Drug Administration
Petition To Regulate Talc
Respectfully Submitted To:
President Donald Trump, Vice President Mike Pence, Congress and The United States Food and Drug Administration
FDA's Authority Over Cosmetic Safety
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA.
Under this current Provision, Baby Powders and Personal Care Powders made from Talc are Classified as "Cosmetics" and are completely UNregulated.
We Petition the United States Food and Drug Administration to Regulate Talc immediately. Under this Regulation we Petition that Talc is Banned in Cosmetics under which category all Baby Powders and Personal Care Powders are specified by the FDA.
Talc is Regulated in Cosmetics in the European Union and on Canada's HotList of Banned and Restricted in Cosmetics.
Talc is proven to cause Endometrial Cancer, Ovarian Cancer, Mesothelioma, Other Cancers (Fallopian Tube Cancer, Cervical Cancer) Talcosis, Systemic Inflammatory Response, and Granulomas. It is lethal to IV Drug Abusers who crush pills for injection. Inhalation of talc by babies is a life threatening Emergency causing Severe Respiratory Distress. Talc is highly suspect as a causative agent behind Sarcoidosis. Talc particles travel through the Body and have been found in the Biopsied Ovaries of women who only used Talc while diapering their babies and not on themselves. Talc particles that travel within the Body cause a deadly Foreign Body Response.
Talc itself is mineralogically similar to asbestos.
Talc itself can be Asbestiform.
There is no such thing as Asbestos Free Talc. Asbestos causes carcinogenesis through a Chronic Inflammatory Response. The FDA acknowledged Talc contains asbestos in their "Postponed Indefinitely" that NO manufacturer can label their Talc as "Asbestos Free" per:
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Sec. 73.1550 TALC. -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
• LABELING (of talc): The label states, where applicable, that the substance is suitable for oral or topical administration. The certificate of analysis states the absence of asbestos. It also indicates:
• that Talc is not derived from deposits that are known to contain associated asbestos, and
• (RB 1-Aug-2011) which method specified in the test for Absence of Asbestos was used for analysis.
• (Postponed indefinitely*)•(RB 1-Aug-2011)
* To date this determination continues to be "Postponed indefinitely" because the FDA knows there is no such thing as "Asbestos free" talc.
The FDA continues to ignore repeated requests by Scientists, Medical Doctors, and Researchers to Regulate and Ban Talc.
The Requests by multiple respected Organizations and Agencies to at the very least apply a "Warning Label" on Talc products has been blatantly ignored.
The FDA completely ignored:
NTP Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807-96-6)(Non-Asbestiform) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).
National Toxicology Program, Natl Toxicol Program Tech Rep Ser. 1993.
The FDA totally ignored that at the very least this Report shows:
Inhalation exposure of rats to talc produced a spectrum of inflammatory, reparative, and proliferative processes in the lungs. Granulomatous inflammation occurred in nearly all exposed rats and the severity increased with exposure duration and concentration.
Hyperplasia of the alveolar epithelium and interstitial fibrosis occurred in or near foci of inflammation in many exposed rats, while squamous metaplasia of the alveolar epithelium and squamous cysts were also occasionally seen.
Accumulations of macrophages (histiocytes), most containing talc particles, were found in the peribronchial lymphoid tissue of the lung and in the bronchial and mediastinal Iymph nodes.
In female rats, the incidences of alveolar/bronchiolar adenoma, carcinoma, and adenoma or carcinoma (combined) in the 18 mg/m(8 mg/m(3) group were significantly greater than those of controls.
Adrenal medulla pheochromocytomas [benign, malignant, or complex (combined)] occurred with a significant positive trend in male and female rats, and the incidences in the 18 mg/m(3) groups were significantly greater than those of controls.
We Petition the FDA to comply and act with the utmost diligence, seriousness and urgency to this Petition because Talc in Cosmetics is Scientifically and Medically PROVEN a Life Threatening Emergency when the "Direction For Use", both implied in marketing and advertising or "Direction For Use" encouraged directly on talcum powder containers by the manufacturers as labeled is applied to the Body of babies and/or self.
It has been repeatedly Documented and Proved during multiple Courtroom Talc Litigations against Johnson and Johnson that the FDA based NOT Regulating Talc in Baby Powder and Personal Care Powders and Products manufactured from Talc or containing Talc, that fraudulent Scientific Reports indicating the Safety of Talc, were submitted to the FDA - WITH THE FDA's KNOWLEDGE - specifically to keep Talc, the Talc Industry, and their Talc Products UNregulated.
This Petition is Primary and concerned with Cosmetics further Classified as:
1. Baby Powder - Manufactured primarily from Talc, or contains Talc in ANY portion or part of its ingredients. Baby Powder can be any Name Brand, Store Brand or Generic Label that contains Talc. Baby Powder is labeled to be "sprinkled" on all of babies bottom as a moisture barrier between diaper changes. Baby Powder made from Talc is generally 99.9% crushed Talc plus fragrance.
It is scientifically proven that crushed Talc is very dangerous.
Crushed Talc particles can appear in the form of microscopic "barbed fish hooks" that embed into internal tissue of the Body through inhalation, and travel into the body through talc exposed External Body orifices, and absorbed through the skin.
It takes at least 8 YEARS, if ever, for ONE particle of Talc Powder to be eliminated from the Body.
If not eliminated, the Talc particles embed into internal body tissues and organs where the Body initiates Foreign Body Response of acute, then chronic inflammation. This type of inflammation leads to Cancer.
2. Personal Care Powders (PCP's) that are manufactured primarily from Talc, or contain Talc in ANY portion or part of its ingredients. PCP's can be any Name Brand, Store Brand or Generic Label that contains Talc. More specifically these Powders can be in a "Dusting" type container usually accompanied with a "Powder Puff" which Studies indicate send Talc Particles in deep concentrations into the air where they are inhaled by the duster. This inhalation is KNOWN to cause serious talcosis, inflamed lungs and Mesothelioma. Accidental inhalation of Talc by babies during diapering has killed babies.
Personal Care Powders are either "sprinkled" or "dusted" directly onto the desired area.
Personal Care Powders are best known by the Brand Names of Johnson and Johnson Baby Powder (implied and directly marketed for use by adult women for "personal hygiene"), Shower to Shower, Cashmere Bouquet, Goldbond Medicated (Talc) Powder for men, along with all of the Store and Generic Brands listing a "Compare To" their Name Brand Counterparts.
We Petition The Regulation of Talc by the FDA regarding the use of and addition to, the mineral Talc manufactured in any of its various forms, sizes and states, specifically as an ingredient as legally described by the FDA as a "Cosmetic" for a total Ban of Talc as:
1. "Active" - the base/primary and/or main ingredient
2. "Inactive" - the Secondary or as an additive or filler listed as "Other Ingredients" and,
3. Used as a "Coloring Agent" in Cosmetics
The FDA is under The Executive Branch of The United States Government. The FDA has not been held Accountable to anyone.
Therefore, We Petition The United States Government to set up a "Watchdog" Committee through a Group comprised of Federal Offices to Audit and INSURE a travesty such as the UNregulation of Talc - much to the detriment of American Citizens and Global Citizens through global sales - NEVER happens again. Talc kills.
The United States Government has a Responsibility to its Citizens to thwart corruption in all Government Bodies. When a Government Institution - in this case, the FDA, continues to allow outdated Rules and Regulations to dictate its Policies despite knowing the Citizens it is suppose to be protecting are dying because of it, it is time to Re-evaluate, Audit, Clean it up, and hold it RESPONSIBLE.
The Policy of not testing the Safety of Products BEFORE they are offered for Sale to the General Public MUST be updated and changed. Currently the FDA relies on the Manufacturer of ANY Cosmetic Product to determine the Safety of its own Product. We Submit that BEFORE a Cosmetic is allowed to be released for Sale the manufacturer must at the very least Submit a recipe of all ingredients in the Product including all cross reactions of ingredients, to the FDA for an FDA Approval Committee to study and approve. The process now is, it is left up to the manufacturers to report ANY Safety Issues with a Product to the FDA - AFTER the fact - but are NOT REQUIRED to do so. ONLY when the FDA gets enough complaints about a Product usually from Citizens do they begin an investigation. This gives manufacturers cart blanche to anything they want to concoct and sell to the Public. Obviously this is not working.
Talc in Baby Powder or Personal Care Powders such as Johnson's Baby Powder and Shower to Shower are considered a "Cosmetic" by the United States Food and Drug Administration and the finished products are NOT REGULATED or tested by the FDA before they are sold to the public.
This Petition also requests the United States Food and Drug Administration immediately update the information they issue in any form including their website to inform the public about talc. The FDA must include that it is scientifically and medically proven that talc causes Endometrial/Uterine and Ovarian Cancers and Mesothelioma in women when used for personal hygiene purposes, Warning consumers that this practice be stopped.
Any and all Baby Powder or Personal Care Powders or Products that contain talc must be RECALLED by their manufacturers and forever banned from further manufacture and sale.
There must be an immediate notification from the FDA to Organizations such as the American Cancer Society and major companies licensed by the United States to manufacture and sell Baby Powder and Personal Care Powders, such as Johnson & Johnson, at the manufacturers expense, for the publication of Public Safety Announcements stating:
"Scientific and medical research have proven that talc causes Endometrial/Uterine Cancer, Ovarian Cancer and Mesothelioma in women and it is highly recommended to all, both male and female to immediately discontinue using products made primarily from or containing any talc, for personal hygiene purposes."
This Petition will be properly Served to The United States Food and Drug Administration with Copies Forwarded to The President and Vice President of the United States, all United States Senators and Congress to the end that this travesty is no longer ignored. Women are dying.
What we are asking should have been done long ago. It is well Past Time that talc be pulled off the shelves.
Rosemary Yuhasz Chatham
Petition Published and Electronically Signed at:
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