Food dyes are of course toxins to one extent or another with no nutritional value. Oddly enough, for whatever reason, the FDA recently decided to ban one of them- FD&C Red # 3. The FDA banned it under the Delaney Clause, which prohibits approving chemicals that cause cancer. The FDA used carefully-worded language that denied that the method by which FD&C Red #3 caused cancer in rats occurred in humans, but did not confirm or deny that FD&C Red #3 caused cancer in humans by another mechanism, despite banning it under an anti-cancer Clause. The Delaney Clause also allows the FDA to ban chemical additives that cause cancer in animals.
The FDA was first the Bureau of Chemistry of the USDA. The Bureau of Chemistry allowed chemicals to be added to human food, including chemical food dyes. The timeline of the creation of the FDA is an informative history that most people are not aware of. This article will present some original source information in a timeline format, much of it from the FDA.
The FDA was born of the Chemical Industry. Chemotherapy came to replace Medicine. They are not the same. Medicine is a Greek term which means to obtain homeostasis in the body through the use of herbs. By creating and controlling regulator agencies, the Chemical Industry replaced Medicine. Their strategy was to poison mankind, creating the need for regulation. In turn, they used the regulations to create approval processes through the requirement of clinical trials. By controlling and manipulating clinical trials, the Chemical Industry able to gain approval for their poisons while simultaneously blocking any true Medicine from being marketed as such (no approved use).
If I had told you that ten years ago, you would have called me a “conspiracy theorist.” Theory is often right, of course. Now most of my subscribers will readily agree that the FDA approves poisons and denies approval of true Medicine. If you want to know how we got here, go back and research the creation of regulations and the “disasters.”
In my opinion, there is no perfect solution to regulation. Clearly we need some. The problem is who controls the regulatory agencies, and what their objectives are.
Various topics are presented in the timeline. We’ll take a quick journey through some topics that would certainly be great articles to write in themselves.
For one thing, I present some original source information that the Thalidomide disaster of 1961 was an intentional disaster to increase the regulatory authority of the FDA, after legislation to give the FDA more regulatory power had stalled. I could back this up much further, and maybe one day I will. There are a few key sources of information in this article for anyone who wishes to research it themselves.
I also have an inline article I wrote about the “Sulfanalimide Disaster” of 1937, which was similar to the Thalidomide Disaster of 1961.
We’ll also take a look at William Welch, of the Rockefeller Institute, Johns Hopkins University, and later the FDA. Welch was also a key person in the so-called Flexner Report of 1910.
And of course, there is some information on chemical additives to food for coloring.
The regulatory history highlights that not all Acts of Congress have been evil throughout history. The sweep of history shows that Congress didn’t understand how their Acts were triggered and how the regulations would be used against the public. The Delaney Act, or the “Food Additives Amendment of 1958,” was an excellent piece of legislation that has been used by consumer advocacy groups to pressure the FDA to ban some chemical additives to food such as FD&C Red #3. I suggest that Congress should pass legislation to forbid any associations of FDA employees with private industry, and that FDA employees should be required by Law to be public servants and consumer advocates only, as they were intented to be all along.
The agency (current FDA, former Bureau of Chemistry Division of the USDA) grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 15,000 employees and a budget of $4.4 billion in 2014, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others.
He (William Welch) served as president of the board of directors of the Rockefeller Institute for Medical Research from 1901 to 1932. During this time, he was an advisor to John D. Rockefeller, who funded the establishment of the Peking Union Medical College. Welch helped set the goals for this western-style medical school which was devoted to research, premedical teaching, and clinical training. He hoped it would become the "Johns Hopkins in China."
Although he received his appointment to head the new Drug Laboratory in November 1902, Kebler’s responsibilities at Smith Kline and French prevented him from assuming his position in the Bureau of Chemistry until the following March. Prior to the Federal Food and Drugs Act, the Drug Laboratory worked on a variety of topics—not all directly relevant to drugs. One of the first projects that Kebler initiated was a study of the Bureau’s own stock of reagents, primarily because this was a long-standing problem that was obviously relevant to any laboratory that relied on analytical procedures. The Drug Laboratory examined over 700 chemicals within two years. This effort—and the problems Kebler discovered in his survey—led the Association of Official Agricultural Chemists (AOAC) to formalize its own concern about the quality of chemical reagents as an issue of national concern. The AOAC created the Committee on the Testing of Chemical Reagents, with Kebler as head, to investigate the quality of these chemicals.13 A common problem Kebler observed was the labeling of a reagent as chemically pure when it was of medicinal quality, or worse. Eventually, reports of this committee became de facto reports of the quality of reagents at the Bureau of Chemistry, since few if any chemists outside of the Bureau were willing to assist the Committee in its work. In any case, the Drug Laboratory early on assumed a central role in organizing efforts to improve pharmaceutical analysis—in keeping with Wiley’s original vision for the laboratory. Kebler remained in charge of chemical reagent testing for the AOAC until the 1920s.
Another cooperative venture between the Drug Laboratory and the AOAC was more directly related to drugs. In its 1903 report, the APhA (American Pharmacists Association) Committee on Drug Adulterations questioned its ability to promote uniformity in drug standards without greater involvement by chemists. The available assay techniques resulted in significant discrepancies even when experienced chemists analyzed the same drug. So, the Committee looked to the Drug Laboratory for help in developing analytical methods to identify drugs with results consistent among . At the same time, the Committee urged the AOAC to appoint a referee on medicinal plants and chemicals. Later that year, the AOAC appointed Kebler as the referee on this subject. Kebler explained why the involvement of the AOAC at this point would be helpful:
The idea of suggesting a referee in connection with the American Association of Official Agricultural Chemists is, that we take up the work on the same lines along which they have been working for a number of years, and thereby bring about uniformity of methods and results. The object is, to have the co-operation of a number of men throughout the country, . . . to bring the analytical methods that are being used by the port chemists before the public, so that we will know exactly what they are doing and thus obtain an exact guide to ascertain whether they are the best, or whether they can be improved upon.
The American Medical Association (AMA) began to push for federal evaluation of new medical products hoping to make a dent in the patent medicine industry, but it was unsuccessful. In 1905, the AMA formed its own Council on Pharmacy and Chemistry which levied a fee on manufacturers to evaluate their drugs for quality (ingredient testing) and safety. Drugs accepted by the Council could carry the AMA's Seal of Acceptance and only products with the seal had access to the advertising pages of the Journal of the American Medical Association (JAMA). The AMA's Chemical Laboratory tested commercial statements about the composition and purity of drugs in their labs, while the Council on Pharmacy and Chemistry followed up with safety evaluations and rudimentary efficacy evaluations designed to eliminate exaggerated or misleading therapeutic claims. Although the Council eagerly sought evidence that drugs had an effect on the cause or course of a disease, the Seal was awarded to drugs that merely provided symptomatic relief. Although the Council would have liked to rely upon clinical studies to supplement laboratory studies submitted by drug manufacturers, they lacked the necessary funding to support such studies and the AMA did not authorize the Council to require them. Instead of relying on the anecdotal information provided by private practitioners, however, the Council relied heavily on the opinions and recommendations of Council members who were well-respected medical specialists and scientists, a progressive practice for the era. Once their evaluations became a regular feature in the Journal of the American Medical Association (JAMA) the Council began to make inroads against the commercialism that physicians had felt were "debauching" medical journals and "tainting" medical textbooks. The AMA's drug certification program remained in place until 1955.
While the AMA Council on Pharmacy and Chemistry held out a carrot of certification to ethical drug products that met their standards, the first federal food and drug statute, the 1906 Pure Food and Drugs Act, wielded little in the way of a stick. The AMA had been unsuccessful in getting any kind of drug review in the new law and the statute merely provided a legal definition for the terms "adulterated" and "misbranded" as they related to both food and drug products and prescribed legal penalties for each offense. The law did empower the Bureau of Chemistry (forerunner of the U.S. Food and Drug Administration) to seize adulterated and misbranded products that moved in interstate commerce, but it simply adopted the drug standards as published in the U.S. Pharmacopeia and the National Formulary. The law also prohibited "false and misleading" statements on product labels. In the case of drugs, the law listed eleven so-called "dangerous ingredients" including opium (and its derivatives) and alcohol which, if they were present in the product, had to be listed on the drug label. This listing requirement alone inspired many manufacturers to abandon use of many dangerous ingredients following passage of the 1906 Act. But efforts to prohibit false therapeutic claims on drug labels were defeated both by the Supreme Court and the U.S. Congress.
The Pure Food and Drug Act was signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930.
The original Food and Drug Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. The Act outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted.
1907. And now finally we get to the approval of chemical additives to food from the Bureau of Chemistry.
Food and Drugs Act. In 1906, Congress passed the Food and Drugs Act, which prohibited the use of poisonous or deleterious colors in confectionery and the coloring or staining of food to conceal damage or inferiority. The USDA had initial enforcement authority for this act. In 1907, the USDA (Bureau of Chemistry Division) issued Food Inspection Decision (F.I.D.) 76, which contained a list of seven straight colors approved for use in food. Subsequent F.I.D.'s in the early part of the century established a voluntary certification program and listed new colors.
The petroleum-based dye (FD&C Red #3) “chemically known as erythrosine, has been approved for use since 1907 to give candies, drinks and other foods their vibrant red color.”
“We are particularly indebted for constant and generous assistance to Dr. William H. Welch of Johns Hopkins University, Dr. Simon Flexner of the Rockefeller Institute…”
By 1911 the federal government employed fewer than 300 chemists, seventy percent of whom worked in the Department of Agriculture (USDA). It is not surprising then that other agencies would turn to this department—and to the Bureau in particular—for assistance with chemical analyses. The Drug Division, with experienced analysts such as Kebler, Emery, Nelson, and others, carried out much work in association with outsiders. For example, the importance of ties between the AOAC and the division with respect to analytical work has already been mentioned. The division analyzed the composition and any therapeutic effect of many quack pharmaceuticals for the Post Office Department: alleged cures for tuberculosis, cancer, drug addiction, epilepsy, syphilis, and other nostrums.
Soon after the 1906 Act had been enacted, a dispute arose over the meaning and enforcement of the drug labeling provisions of the law. The Supreme Court ruled in U.S. v. Johnson in 1911, that the new law did not prohibit false therapeutic claims – the product involved was labeled Dr. Johnson's Cure for Cancer – it just prohibited "false and misleading" label claims regarding the ingredients or identity of the drug.
This technicality limiting enforcement powers would be solved later when “disasters” occurred which highlighted the limitations of enforcement powers.
In 1912, Congress quickly enacted the Sherley Amendment, a compromise that merely prohibited false therapeutic claims "intended to defraud" the consumer. Proving that a proprietor knew that his drug was worthless in order to demonstrate fraud under the statute, however, could be a daunting task. To cite a single example: an old patent medicine maker created a "cure" for diabetes which he marketed as Banbar. Its active ingredients included milk sugar and equisetum (horsetail). The product was particularly dangerous since diabetics were rejecting insulin injections in favor of Banbar (the hormone insulin had been isolated in 1922 and was a lifesaving therapy for diabetics). FDA seized the product in the mid-1930s, charging the proprietor with fraud under the Sherley Amendment. In his defense, the proprietor submitted testimonial letters written to him thanking him for the product. His lawyer argued that it was obvious, since these sincere people took the trouble to write him and thank him, that he had no idea that the product might not be effective much less dangerous. Government officials selected a representative group of testimonial letters and matched them side-by-side with death certificates from the same individuals indicating that they had died from diabetes. Although the public health threat was obvious, the court ruled that the proprietor had not intended to defraud his customers and the product remained on the market until Congress enacted a new food and drug statute without this so-called "fraud joker" in 1938. Banbar, in particular, gave drug regulators their first direct experience interpreting drug data obtained not from direct clinical trials, but from both uncontrolled trials and "historical" data, one of three types of clinical trial data eventually recognized as acceptable under law in 1970
The Bureau of Chemistry's name changed to the Food, Drug, and Insecticide Administration in July 1927, when the non-regulatory research functions of the bureau were transferred elsewhere in the department. In July 1930 the name was shortened to the present version (omitting “Insecticide” from the Food and Drug Administration (FDA)).
Note: There’s a great deal of information about how the USDA defended the practice of spraying fruits with toxins like Arsenic and DDT. Practices that caused paralysis and death, falsely blamed on a virus (that’s another story). You can read some here:
This is a summary of literature on the truth of Polio. This summary has a lot of “cut and paste” of original sources. It’s my belief that you should read the original sources to learn the truth. A quick summary:
In 1927, responsibility for enforcing the Food and Drugs Act of 1906 was given to the newly established FDA. (The agency was first called the Food, Drug, and Insecticide Administration and was given its current name in 1930.) By 1931, there were 15 straight colors approved for use in food, including six of the seven 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).
The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.
1937-1938. The Sulfanalimide Disaster highlights the limitations of 1906 Pure Food and Drug Act. Only “mislabled” products were regulated.
Most consumers were unaware of Banbar, but in 1937, a broader drug disaster did capture public attention and first drew the federal government into playing a limited, but soon growing role in the evaluation of new drugs, including the conduct of clinical trials for new drugs. In 1937 a drug company developed a liquid preparation of the first "wonder drug" sulfanilamide, used to fight streptococcal infections (i.e. strep throat). The product was not tested in animals or humans prior to marketing. The solvent used to suspend the active drug, diethylene glycol, was a poison (chemically related to anti-freeze). It required the entire field force of the FDA to retrieve all available bottles of Elixir Sulfanilamide when the company's own recall efforts proved inadequate to the task. FDA officials soon discovered that adequate records had not been kept by either physicians or pharmacists documenting prescriptions written and filled for the poisonous product. FDA, however, was only empowered to act against the deadly product because it was misbranded – it contained no alcohol whereas the term "elixir" implied that it did contain alcohol. Congress reacted to the tragedy, which killed over 100 people, by enacting a new federal food and drug statute, the 1938 Food, Drug, and Cosmetic Act. A new provision in the act-- requiring drug sponsors to submit safety data to FDA officials for evaluation prior to marketing -- appeared with relatively little discussion following on the heels of the Elixir Sulfanilamide disaster. "Instead of going to market based on their own assessment of the drug, sponsors had to notify the FDA of their intent to market the drug by submitting an NDA (New Drug Application),”
In June 1938 President Roosevelt signed the Federal Food, Drug and Cosmetic Act into law. Among other things, this law required new drugs to be tested for safety before marketing, and the results submitted to FDA in a new drug application (NDA). The law also required that drugs have adequate labeling for safe use.
You can read more on the “Sulfanalimide Disaster” here. The name given to the disaster disguises the real culprit, Diethylene Glycol.
In 1951 William Welch was appointed director of the (FDA) Division of Antibiotics, where he was responsible for the approval of new drugs. Martí-Ibáñez had a business plan. In 1951, he put it into action. He and Welch joined forces to found a new journal, entitled Antibiotics and Chemotherapy, with an editorial board that included a who’s who of antibiotic research, including Florey, Waksman, and Alexander Fleming. Martí-Ibáñez, as president of MD Publications, would run the business side; Welch would be the editor.
The Food Additives Amendment and the Color Additives Amendments include the Delaney Clause, which prohibits the approval of an additive if it is found to induce cancer when ingested by people or animals, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in people or animals. Any substance found to cause cancer is regulated under the general safety provisions of these laws, as well as by the Delaney Clause include a provision which prohibits the approval of an additive if it is found to cause cancer in humans or animals. This clause is often referred to as the Delaney Clause, named for its Congressional sponsor, Rep. James Delaney (D-N.Y.).
The complete text of the "Food Additives Amendment of 1958" (Delaney Clause) can be read here:
For John Lear, alarm bells sounded. When he interviewed Welch for his February 1959 article and asked him to confirm or deny the rumor that he derived substantial income from the journals, Welch replied, “Where my income comes from is my own business [but] I have no financial interest in MD Publications. . . . My only connection is as editor, for which I receive an honorarium.” It would be some months before the size of that honorarium was fully understood. Antibiotic Medicine and Clinical Therapy paid Henry Welch 7.5 percent of all advertising revenue, and 50 percent of all sales of article reprints. In the four years between the journal’s introduction and John Lear’s exposé in Saturday Review, the two “honoraria” had paid Henry Welch nearly $250,000, about $2.24 million today. Welch, it was later learned, had told a number of colleagues that his FDA salary—$17,500 a year—was barely enough to pay his income tax. They thought he was kidding. ……. As a direct result of John Lear’s articles, Congressman Emanuel Celler of New York insisted that Welch should be fired, and soon enough, Dr. Arthur Flemming, the secretary of the Department of Health, Education, and Welfare, demanded his resignation.
Democratic Senator Estes Kefauver of Tennessee had been investigating pharmaceutical companies — chiefly their pricing practices — since 1959, but he had failed to rally support behind reform. In the aftermath of the revelations from Europe about thalidomide, the senator’s staff dug into the FDA’s deliberations on the drug and unearthed Kelsey’s dealings with Merrell. Spotting the story’s political capital, they leaked it to The Washington Post, which reported it to an unsuspecting nation on July 15, 1962.
The U.S. Senate held hearings in June 1960 to strengthen the drug provisions of the 1938 Act. These hearings, chaired by Senator Estes Kefauver of the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary, resulted in S.3815. This bill aimed to protect the public health by instituting certain manufacturing practices, expanding antibiotic certification to all antibiotics, and by other measures.
1961-1962. The Thalidomide Disaster erodes opposition to increased FDA powers.
A worldwide drug disaster in 1961 resulted in the enactment of the 1962 Drug Amendments, which explicitly stated that the FDA would rely on scientific testing and that new drug approvals would be based not only upon proof of safety, but also on "substantial evidence" of a drug's efficacy [i.e. the impact of a drug in a clinical trial setting]. Increasingly, responsibility for testing standards previously established as voluntary by the American Medical Association's (AMA) Council on Drugs, the U.S. Pharmacopeia and the National Formulary were taken up by the FDA. Since 1962, FDA has overseen substantial refinements to the broad legal requirement that post-1962 new drugs be approved on the basis of "adequate and well controlled" studies.
The total number of people affected by the use of thalidomide during the mother's pregnancy is estimated at more than 10,000, of whom approximately 40 percent died at or shortly after the time of birth.[3][8] Those who survived had limb, eye, urinary tract, and heart defects.[6] Its initial entry into the US market was prevented by Frances Kelsey at the FDA.[4] The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries
As a result of the worldwide thalidomide disaster, countries around the world, including the United States, updated their drug regulatory systems and statutes. "In next to no time," recalled Frances Kelsey, "the fighting over the new drug laws that had been going on for five or six years suddenly melted away, and the 1962 amendments were passed almost immediately and unanimously."
As a result of the narrowly avoided tragedy in the U.S. from thalidomide, Senator Estes Kefauver re-introduced his bill. On October 10, 1962, President John F. Kennedy signed the Drug Amendments of 1962, also known as the Kefauver-Harris Amendments. These Amendments required drug manufacturers to prove to the FDA that their products were both safe and effective prior to marketing.
The Drug Amendments also addressed the use of drugs in clinical trials, including a requirement of informed consent by subjects. FDA had to be provided with full details of the clinical investigations, including drug distribution, and the clinical studies had to be based on previous animal investigations to assure safety.
In the wake of the new law, the Division of New Drugs was restructured in 1962. The Investigational Drug Branch, directed by Dr. Frances Kelsey, evaluated proposed clinical trials for compliance with investigational drug regulations.
I also note that of all the downloads and webpages that I had researched and saved from the FDA, only one was subsequently removed from the FDA website and can now only be accessed through the Internet Archives.
This is an important document that I would be unable to find today if I searched for it without saving the link. The FDA removed it after I clicked on it several times and downloaded it as part of a large research effort on Thalidomide.
The petroleum-based dye, chemically known as erythrosine, has been approved for use since 1907 to give candies, drinks and other foods their vibrant red color. While its cosmetic use was banned in 1990 under the Delaney Clause—a federal rule prohibiting additives that have been found to cause cancer in humans or animals—it has remained in food and ingested drugs.
The FDA is amending its food additive regulations in response to two food additive petitions, to no longer allow for the use of a total of 7 synthetic flavoring substances and flavor enhancers (adjuvants). The FDA determined that the data presented in one of the petitions submitted to the FDA by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids’ Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff show that 6 of these synthetic substances caused cancer in laboratory animals under the conditions of the studies. The seventh synthetic flavor is being de-listed because it is no longer used by industry.
The 6 flavoring substances include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This clause, enacted in 1958, requires that the FDA cannot find as safe; i.e., cannot approve, the use of any food additive that has been found to induce cancer in humans or animals at any dose.
Earlier this month, a popular Easter candy was called out by nonprofit Consumer Reports for containing one such color additive, known as Red Dye No. 3, because high doses of it have been found to cause cancer in animals.
Red Dye No. 3, officially known as erythrosine or FD&C Red No. 3, is a synthetic dye derived mainly from petroleum.
In the U.S., Red 3 has been banned for decades in makeup and topical medicines after being linked to cancer. But it remains approved for use in foods, dietary supplements, and oral drugs – found in popular candies, fruit cocktails and plenty of other foods on grocery store shelves.
Consumer health groups have been calling on the U.S. Food and Drug Administration to ban its use in food for years, citing the risk of cancer and other health problems. This includes Thomas Galligan, a PhD with the Center for Science in the Public Interest (CSPI), a nonprofit group that advocates for safer and healthier foods.
Galligan said the FDA should have banned Red Dye No. 3 in foods, dietary supplements, and oral drugs "more than 30 years ago."
"FDA itself concluded in 1990 that Red 3 is an animal carcinogen, and federal laws explicitly prohibit use of color additives that cause cancer in humans or animals," Galligan told FOX Television Stations. "As a result of that decision, FDA banned use of Red 3 in cosmetics and topical drugs in 1990, but determined it would need to take separate action to ban it in foods, supplements, and oral drugs."
"The agency promised to take steps to do so, but never did," he added.
The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.
