Salon Allergy Specialist

Salon Allergy Specialist

Sunday, August 18, 2013

The FDA has no authority over PPD in hair color, a timeline history

I read on boards, and get e-mails, where people blame the FDA for not regulating PPD better. Congress has removed the FDA's ability to control, change, or even adjust hair color. They can monitor, and collect cases of people who have had an allergic reaction. If you have had one (or several...) please go to this link and fill out the paper work.

This is a brief timeline of sorts compiled from several articles I have collected over the past 10 years of studying this allergy. It might help to explain some of the futility of it all.

1845 - August Wilhelm Hoffman had started to work with compounds such as indigo and coal tar in the 1840's. He names them aniline dyes. Anil, from the Arabic word for indigo.  He prepares this aromatic amino compound in two steps from the coal tar hydrocarbon benzene.  There were other other coal tar hydrocarbons, such as toluene, naphthalene and anthracene.

1856- William Henry Perkins discovers the first completely synthetic aniline dye. It was to replace Madder Root, which imparts different shades of red.

1862- The London World Exhibition has an exhibitor with a "slab" of aniline. It had been produced from 2,000 tons of coal tar, was 20 inches high, and 9 inches wide.

1881 - U.S.Department of Agriculture (U.S.D.A.) authorizes artificial coloring in cheese and butter. The Chemistry department begins research on colorants.

1900 - Coloring agents are used to hide inferior or defective food.

1902 - American Pharmaceutical Association (A.Ph.A.)  requests more standardization for medicine. Percentage of potency in most drugs was well below what was labeled.

1906 - The 1906 Food and Drug Act - Prohibits the use of poisonous or deleterious colors in confectionery, and the coloring and staining of food to conceal damage or inferiority.

1907 - The U.S.D.A. issues the Food Inspection Decision (FID)

1910 - Gaston Boudou produced the first commercially available PPD hair dye in France. It is called, "Inecto"

1912 - Harvey Wiley leaves the U.S.D.A. after 29 years. (1883-1912) He shockingly goes to work for "Good House Keeping Magazine" as the Director of the Bureau of Foods. He chooses this move as a statement about the way that the government is ignoring the issues of purity and safety of food, drugs, and cosmetics. It was also a statement towards the rising power of women's groups, and women as consumers in the marketplace.

1927 - The United States Food and Drug Administration is formed. (F.D.A.) It was called the "Food Drug and Insecticide Administration" at the time, the current name was given in 1930.

1931 -  15 straight colors were approved for use in food. Here are 6 of the seven still in use today :

FD&C Blue No. 1 (Brilliant Blue FCF), 
FD&C Blue No. 2 (Indigotine),
FD&C Green No. 3 (Fast Green FCF),
FD&C Red No. 3 (Erythrosine),
FD&C Yellow No. 5 (Tartrazine), and
FD&C Yellow No. 6 (Sunset Yellow)

1933 -  Lash Lure, a permanent mascara containing Para-phenylene Diamine, has been on the shelves. The FDA is unable to have it removed from the market despite attempts. More than a dozen women had been blinded, and one had died. This was recounted in a 1936 book by Ruth DeForest-Lamb, "The Chamber of Horrors". There were no rules for testing new cosmetics at this time. There were many other cosmetics that had problems in this era, such as Radithor, a radium laced water that was said to restore one's virility, and mercury based skin lighteners.

1937 - Elixir sulfanilamide. This  was an antibiotic that was used in tablet and powder form for several years to treat streptococcal infections successfully. The S.E. Massengill Co. had a chemist who found that the powder would dissolve in Diethylene Glycol, or anti-freeze. The chemist did not know it would be deadly. No testing had been done for toxicity, only for taste, fragrance, and appearance. 107 people died, most of them children. The name given to this mixture, "Elixir", gives the mixture an alcohol based category. This allowed the FDA to seize all products. If the product had been given the proper name, "Solution", no violations would have been made, and the FDA would have been powerless to remove the drug from the shelves. The S.E. Massengill Co. was charged with misbranding.  Dr. Samual Evans Massengill, the firm's owner, said: "My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." The chemist had committed suicide before the trial, so he must not have shared his feelings.

1938 - The Federal Food, Drug, and Cosmetic Act of 1938 - This act further increased government oversight of food and drugs, and for the first time, CONGRESS passed legislation for the regulation of cosmetics and medical devices. For color additives, the 1938 FD&C Act mandated the listing of those coal-tar colors (other than coal-tar hair dyes) that were "harmless and suitable" for use in foods, drugs, and cosmetics; required the listing of new colors; and made mandatory the previously voluntary certification program for batches of listed colors, with associated fees.  Mr. Charlie Crawford, who was head of the FDA, was instrumental in rushing to get this 1938 law passed through congress. There had been a lot of arguing, and no one could agree as to what should be on it, or what should be left out. Once the sulfanilamide deaths had occured, Mr. Crawford had made sure this law was expedited before something else happened, and he was sick with emphysema.

Congress, in 1938, passed a law that said the FDA has no authority over hair dyes. This has not been changed. Until we go to Congress, and plead our case, it will remain the same.

1953 - In upstate NY, Mr. Weilerstein, an FDA worker, makes out a report on a farm that is cutting down old tough beets, and canning them, and selling them as baby beets. The company contacts their congressman, and the result is that they had the first R.I.F, or a Reduction In Force. Some of the  Civil Servants didn't have their permanent jobs yet. The reasoning was that Mr. Weilerstein had nothing better to do than harass the company.

1954 - Mr. G. Larrick becomes commissioner. He builds up the FDA again. He was also responsible for tracking down all of the sulfanilamide in 1937. He was head during it's greatest growth, which had expanded tenfold, according to his leader history on the FDA web sight. Larrick was also known for his ability to get along with Congress, and many investigations came to fruition during his time as commissioner. He resigned in 1965.

1955 -  Division of Biologics Control becomes an independent entity within the National Institutes of Health, after a polio vaccine  is thought to have been inactivated, and  is associated with about 260 cases of polio.

1958 - Food Additives Amendment is enacted, which required manufacturers of new food additives to establish safety. The Delaney proviso prohibited the approval of any food additive shown to induce cancer in humans or animals.

1959 -  Aminotriazole, a weedkiller found to cause cancer in lab animals is found on the U.S. Cranberry crop 4 days before Thanksgiving. Cleared berries were allowed labels showing that they had been tested and cleared; the only such endorsement ever allowed by FDA on a food product before. 

1960 - In the fall of 1960, many children became ill from eating orange Halloween candy containing 1-2% FD&C Orange No.1 a color additive approved for use in food. The FDA re-evaluated all of the listed color additives. They found that there were many that needed to be removed from the list. It also had become clear that coal was no longer the primary raw material source for the manufacture of color additives. This prompted the Color Additive Amendment.

Color Additive Amendment  was enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney Clause prohibits the approval of any color additive shown to induce cancer in humans or animals. 

Federal Hazardous Substances Labeling Act, enforced by FDA, requires prominent label warnings on bottles of Thalidomide, and hazardous household chemical products.

1962 - Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.

This was the "Drug Industry Act of 1962", that the FDA was trying to pass. (it does not) What was passed was the Kefauver-Harris Drug Amendments to ensure drug efficacy and greater drug safety.

This is a partial excerpt from a court hearing for the Drug Industry Act of 1962:

"At a hearing before the Food and Drug Administration held in Washington on  January 6 1956, Dr. Adolph Rostenberg, a consultant for the Food and Drug Administration testified to the effect that the patch test was prescribed by the present Food Drug and Cosmetic law was a highly accurate means of discovering whether or not a prospective user of coal-tar hair dyes was allergic to the product.

Dr. Louis Schwartz, former medical director of the U.S. Public Health Service, testified at the same hearing to the effect that the incidence of allergy to para- phcnylenediamine hair colorings (paraphenylenediamine is a chemical commonly used in the permanent type of hair dyes) was low; that he had examined thousands for incidence of allergy to such dyes and it was nil. His testimony further showed that of millions of bottles of a well known permanent type of coal-tar hair dye sold, a ratio of less than 0.00001 percent complained of alleged allergic reactions. 

No one has ever claimed that hair dyes were toxic or poisonous. The incidence of Injury due to allergic reaction is much too small to justify the proscription (or removal) of these widely used products. There are over 150,000 beauty shops in the United States. Over 800,000 persons are employed In the beauty shop industry. Gross income received by beauty shops total’s over $2.500 million a year. Hair coloring is estimated to constitute over 40 percent of the business of these beauty shops. Without hair coloring
business, few of the 150,000 beauty shops could survive, and hundreds of thousands of idled hairdressers and other employees would greatly expand the already large body of unemployed. Drug and department stores sell milllions of dollars worth of hair dyes yearly. Should section 103 be adopted, these stores would lose an important segment of their business.

Despite the economic disaster which would follow the outlawing of hair colorings. We would not urge it as an excuse for permitting the sale of coal-tar hair dyes if such sale were not amply justified. However, from all of the facts available it must be clear to any impartial observer that there is no justification whatsoever for prohibiting the sale and use of these materials. Millions of women today color their own hair or have It colored in beauty shops. They will not willlngly abandon the use of hair colorings for the enhancement of their personal appearance."
{This is a partial court statement before Honorable Oren Harris, by Ralph L. Evans, Ph. D. (from a well known hair product company, that the name was withheld) H.R. 11582, section 103 be denied.}

Other letters written to the court were found online, you can click on the link and read them for your self.

1965 - Drug Abuse Control Amendments are enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens.

1966 - FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.

1968 - Reorganization of federal health programs places FDA in the Public Health Service

1970 - FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits

The rest of the information does not contribute to the PPD information that is my passion. You can click on the link below and read the rest of the history. There is also a link provided for where much of the information came from for this post.

I chose to post this information so people will know that congress passed a law in 1938 that the FDA has their hands tied for hair color.

Links : (weilerstein) (crawford) (larrick)