What the FDA Won't Tell You About FDS
Page, Joseph A.
What the FDA won’t tell you about FDS by Joseph A. Page When feminists are looking for a good illustration of what’s wrong with American business, they often point to feminine hygiene...
...The Alberto-Culver material described tests performed on animals and humans to determine irritancy, rate of hexachlorophene absorption, and levels of hexachlorophene in the blood (as well as odor evaluations made by trained “sniffers...
...Vaginal deodorant manufacturers have now removed this toxic chemical from their formulas...
...Products which alter bodily function are considered to be drugs...
...Until the summer of 1971, the FDA called the sprays cosmetics and let it go at that...
...Instead of asking for legislation to strengthen its inadequate laws, or using what powers it could to regulate the hazardous, poorly tested sprays, the FDA has continued to cooperate with the industry in delaying reform...
...In other words, the products should be regulated as drugs...
...This drastic proposal must have horrified his superiors, for on the same day, the office of the acting director issued an action memorandum repeating the earlier memo verbatim, but deleting the recall provision and changing the conclusion to find that the sprays “may be hazardous...
...Several letters from gynecologists describing adverse reactions their patients had suffered after using the sprays appeared in medical journals...
...The commercial success entailed certain sacrifices, one of which was adequate safety testing...
...The encounter lasted all of 10 minutes...
...For nearly two years, a combination of weak laws and timid administrators has kept the government from taking the steps necessary to protect the public...
...Charles C. Edwards demanding that Walden be fired and claiming that Alberto-Culver had “voluntarily submitted to the FDA scientific findings which completely refute Walden’s irresponsible state ments...
...The period for comment expired on March 8, and the usual bureau cratic delay settled over the issue...
...Conclusion: No irritation or other abnormality which could be attributed to the use of FDS was observed...
...In any event, the short-term medical record is alarming enough...
...The line between “cosmetics” and “drugs’’ is therefore important, but it is also exceedingly fine...
...Meanwhile, the Bureau of Drugs was also studying the problem and suggesting regulatory approaches...
...It kills bacteria [whose] . . .balance is in fact important to body function...
...The market fell off in 1972, mainly because hexachlorophene, an ingredient in some of the sprays, received widespread publicity as being responsible for the deaths of more than 30 babies in France...
...There was also a prod from elsewhere in the government...
...A Game of Charades At the same time, an article in the October, 1972, issue of Ms...
...Congress, by failing even to hold hearings on the subject, has long demonstrated its indifference to cosmetics regulation...
...in 18 cases investigated by the government, patients required an average of 30 days to recover...
...But a company can challenge these sanctions in court, and the burden is on the agency to prove that the law has been violated...
...Whether the saga of the sprays will ruffle this blanket of neglect remains to be seen...
...This wouM give a reaction rate of just under 25 per cent...
...If it is, then the FDA can require the product to meet the same standards as other drugs, most crucial of which are pre-marketing safety tests...
...Edwards to protest the FDA’s decision...
...Upon careful review of each clinical report form, seven of the 32 patients showed signs of symptoms of irritation or erythema...
...Physicians point out that odors can be a sign of disease, and that by blocking normal warning signs, a too-assiduous use of deodorant could delay needed treatment...
...Then, in a decision that was to vaginal sprays what the 21st Amendment was to brewers, the National Association of Broadcasters decided to reverse its long-standing rule against televised advertisements for “intimate products...
...Edwards and repeat his demand...
...they state that the product “stops odor before it starts,” implying prophylactic benefit...
...The weaknesses in the Food, Drug, and Cosmetic Act forced the agency to take this approach...
...The new order retained the preservative loophole and the 0. l-per cent limit, but, in response to a written comment submitted by the author and one of his students, it also incorporated a requirement that calculations of the hexachlorophene content in aerosol products be made exclusive of the propellant...
...Once inflammation sets in, it can be persistent...
...Though Dr...
...This was sound medical judgment and plain common sense...
...The latest installment in this continuing story came in February, 1973, when the Food and Drug Administration (FDA) failed to issue long-expected regulations for the sprays and gave no clue to its next step...
...Denounced as both useless and hazardous by doctors and promoted through advertising demeaning to women, the sprays are a classic case of adding injury to insult...
...That such an odor exists has long been known, but that it is anything but normal was hardly suspected before 1966, when the first of these deodorants hit the U. S. market...
...The patient that dropped out did so because of irritation on the right inner thigh which became progressively worse, forcing her to drop out of the study after two weeks...
...In late January, 1973, word leaked out that the FDA was on the verge of requiring warnings on spray labels, so that an intelligent consumer would think twice about using a vaginal deodorant...
...At least 30 different brands appeared, some seeking distinction by offering “flavors...
...Let the Sprayer Bewarle Between these less-than-reassuring tests and the growing pile of complaints, the FDA was being pushed to act...
...Experts feel the most serious problems may not be apparent until the sprays have been tested over time...
...as The Medical Letter advised its physicianreaders recently, “It is unlikely that commercial deodorant feminine hygiene sprays are as effective as soap and water in promotion of a hygienic and odor-free genital surface...
...their only function is to guard against “vaginal odor...
...Last spring, one manufacturer offered spray samples for 25 cents to more than a million women in college...
...The information contained in these studies does not contribute anything to our understanding of the injuries reported to US,’’ wrote Dr...
...In fact, some of the sprays without hexachlorophene caused as many complaints as the rest...
...Gynecological Grumldings The Food, Drug, and Cosmetic Act of 1938 provides the legal framework for FDA authority over the sprays...
...While failing to come to grips with the problem of vaginal deodorants, the FDA adopted an elaborate scheme of “voluntary regulations” drawn up by the cosmetics industry to create the impression of adequate self-regulation in order to obscure the need for new legislation...
...The FDA’s response was to meet with industry representatives and ask them to cooperate by voluntarily furnishing the agency with information, including safety-test data...
...Then disturbing signs appeared...
...Schwartz’s description of the same study: Thirty-two human subjects were started on an uncontrolled study in which each patient was examined by a physician and then given a can of FDS to use either two times a day or four times a day depending on her preference...
...One part of the feminine hygiene deodorant story that has not been explained is the federal government’s role...
...In the few years the products have been on the market, there has not been time to determine whether there are any long-term risks...
...Intead, the agency began to move against hexachlorophene because of increasing evidence that the chemical was unsafe...
...they do not have to give directions that would insure that the sprays are not applied with excessive force (or at too close a range) and in such a way that the ingredients will not reach the vaginal orifice...
...In fact, the law does not even oblige cosmetics manufacturers to tell the FDA that they are in business, let alone what products they peddle or what ingredients the products contain...
...Ever ready to pick up the gauntlet, Alberto-Culver President Leonard Lavin immediately sent an angry telegram to HEW Secretary Elliot Richardson and FDA Commissioner Dr...
...Whether they could be classified as drugs under existing law and its interpretation by the FDA and courts was another matter...
...Fifteen doctors from the student health service at the University of California at Santa Barbara wrote to Virginia Knauer, President Nixon’s Adviser on Consumer Affairs, urging that the sprays be withdrawn from the market...
...Edwards refused to budge on the measurement issue, the FDA did modify its final regulation to ban the use of any hexachlorophene in cosmetics which might come in contact with mucous membranes...
...They are intended to be sprayed on and around the perineal area...
...antibacterial (until recently, the nowbanned hexachlorophene), and an aerosol propellant...
...No FDA scientific personnel attended...
...Sometimes, under FDA rules, a cosmetic is not just a cosmetic, but a drug as well...
...There is no medical justification for [hexachlorophene] in feminine hygiene deodorant sprays,” Walden said...
...Each patient was then examined at intervals for signs of irritation or erythema...
...they state that the product(s) have been tested by gynecologist(s)-an implied claim of medical efficacy...
...they state that the product “keeps you fresh all day every day,” implying a change in body function or condition...
...What happened within the Bureau of Foods illustrates how promptly regulatory proposals can be watered down as they pass through the pipeline...
...There was (and still is) no requirement that companies test cosmetics for safety before marketing them...
...But, instead of pursuing this line (which would have acknowledged the Bureau of Foods’jurisdiction over the sprays as cosmetics), the Bureau of Drugs pressed for an agency finding that sprays containing hexachlorophene were drugs...
...When one woman sued for injuries she attributed to FDS, Alberto-Culver’s Gus Kass said in a sworn answer to an interrogatory: To determine whether FDS was irritating under use conditions: 31 women completed the test over a period of five weeks...
...The usual reported adverse-reaction rate for cosmetics is one per million units sold...
...Emphasis ad de d .] This account makes for an interesting comparison with Dr...
...On January 7, 1972, the FDA made its first move, publishing a proposed regulation which, if adopted, would have limited the amount of hexachlorophene in drugs and cosmetics...
...Henry E. Simmons, director of the Bureau of Drugs, spelled this out in more elegant form in an action memorandum dated October 29, 1971: The vulva and vagina represent areas of the body that are in a constant state of change...
...In an “action niemorandum” dated October 19, 19’71, a medical officer in the Bureau argued for a ban on the sprays: I would suggest that products intended to prevent the development of skin odor in the external perineal [genital] area and dispensed from pressurized containers be considered hazardous per se and may not be offered for sale in interstate commerce unless adequate evidence is presented to the FDA that they are safe under reasonable conditions of use...
...The study was conducted under the supervision of a gynecologist...
...The next day Lavin flew to Washington to meet with Dr...
...Complaints from consumers claiming injury from the sprays were arriving at a rate higher than usual for a cosmetic, and there were sustained grumblings from the medical profession...
...Warner-Lambert, however, chose not to let the agency see any data, despite ads claiming that Pristeen “has been developed out of intensive research and tested in leading hospitals under the supervision of gynecologists...
...Sales jumped from $20 million in 1969 to $67 million in 1971...
...The companies can continue to use the word “hygiene” on labels, misleading though it may be...
...Ed wards promised he would have no comments for reporters concerning the status of the sprays...
...Al b er t o-Culver put forward the best face it could, especially when FDS was challenged in court...
...On November 10, 1971, FDA press officer John T. Walden said the agency acted because the chemical was not only potentially harmful but unnecessary...
...A paper Hutt delivered while a partner in a Washington law firm and general counsel to the cosmetics industry’s trade association spelled out the fine distinction the FDA had drawn between a “product that absorbs perspiration or masks its odor, or prevents odor by germicidal or bacteriostatic agents that act upon odor- producing bacteria” (a cosmetic) and a “product designed to reduce perspiration odor by reducing the perspiration itself, through a change in the sweat glands” (a drug...
...The Commis sioner didn’t sack Walden, but that wasn’t Lavin’s real objective...
...On October 20, an advisory committee of obstetricians and gynecologists set up to counsel the FDA voted its opinion that the sprays should be considered drugs and that there is inadequate evidence of their safety and some presumptive evidence that they are unsafe...
...Marked variations occur daily, hourly, and even momentarily under the influence of hormonal stimulation, sexual stimulation, pregnancy, and normal aging...
...When FDA’s medical officials looked over the Alberto-Culver test data, they were not pleased...
...In a September 29, 1971 memo to a medical officer in the Bureau of Drugs, the FDA’s newly appointed legal counsel Peter Barton Hutt gave his opinion of how the law had been construed: “Antibacterial agents [such as hexachlorophene] in deodorants are not intended to affect a bodily function or prevent disease, but only to promote attractiveness...
...Moreover, it led to the inescapable conclusion that vaginal deodorants ought to remain out of the hands of consumers until the manufacturers proved their safety with valid data obtained through sound testing procedures...
...But the company omitted information on how much of the spray normally penetrates to internal areas, which is surprising since millions of women had been using the product for several years...
...A current TV commercial actually seeks to capitalize on this turn of events,by advertising that Warner-Lambert’s Pristeen is now free of hexachlorophene-although the company had previously done virtually no labeling or advertising to inform the consumer that Pristeen did contain the chemical...
...A letter from an FDA medical officer in The New England Journal of Medicine said “evaporation of the propellant may raise the concentration of hexachlorophene to as high as 95 per cent on the skin immediately after application...
...There was no doubt that the companies were using hexachlorophene as an active ingredient in vaginal deodorants...
...The Race to the Market Shelf - ~ ~- ~ The reason for this less-than-thorough testing was Alberto-Culver’s determination to beat the competition to the market shelf...
...As one woman commented after a frustrating round with the FDA, the sprays won’t be regulated until they are found to cause cancer of the mouth...
...Internal FDA memoranda prepared by scientists in the Bureau of Foods and the Bureau of Drugs during October, 197 1 , spelled out the dimensions of the safety problem: four manufacturers admitted receiving 383 complaints, physicians reported approximately 30 injuries, and the FDA received 18 complaints: directly from consumers...
...No smears or cultures were made...
...An August 4, 197 1, memorandum argued that vaginal deodorants were mislabeled and hence subject to recall: The claims made for the product are misleading in that: they imply that one spray will prevent odor all day...
...Slow Down, Don’t Move Too Fast So near the end of 1971 the FDA was stewing busily, but a firm policy decision on the sprays was never reached...
...Since no product presently on the market meets these conditions, they should all be recalled and it would be incumbent on those who propose to market such products to determine the offending ingredient or ingredients and take such corrective measures as might be indicated to make the product safe...
...Interested parties were given 60 days to comment...
...The memo of October 4 spelled out the reasons: 1. The nature of the use...
...The competition has yet to recover...
...One approach the FDA took was to urge manufacturers to remove hexachlorophene from the sprays voluntarily...
...For those who have an odor problem soap can’t solve, the sprays may actually be a danger...
...The most common reactions are itching, burning, and rashes, often leading to conditions technically known as cervicitis, cystitis, urethritis, vulvitis, and vaginitis...
...The FDA never explained the basis for its “preservative” loophole...
...It took the deaths of 30 babies in France from talcum powder containing hexa chlorophene to jar the agency into decisive action...
...But in less than two weeks the regulations had once again been delayed indefinitely...
...On ithe basis of the above figures, the rate for vaginal deodorants was running about 10 times higher...
...The main test seems to be intent: the law states that a cosmetic may be a drug if it is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “is intended to affect the structure or any function of the body...
...Warner-Lambert was actually the first company to test-market a vaginal deodorant, but Alberto-Culver won the race to national distribution, advertised heavily, and established FDS as the market leader...
...The agency responsible, the Food and Drug Administration, has floundered, and the story of its hesitation tells a lot about how government can fail...
...Moreover, in permitting these products to masquerade as cosmetics, we presently allow them to be sold with labeling that is false and misleading, lacking adequate precautionary statements and instructions for use...
...Unlike the FTC, which has legal authority to subpoena information from industry, the FDA must rely on the manufacturers’ good will...
...Since most of the sprays contained hexachlorophene, some officials felt that reducing the amount of the chemical might solve the spray problem...
...The Federal Trade Commission (FTC), responsible for scrutinizing the product’s advertisements, formally asked manufacturers to back up their advertising claims with facts...
...Feminine hygiene sprays are not, as their name might imply, related in any way to health...
...Fr0.m the manufacturer’s point of view, there is only one complication in this permissive arrangement...
...Despite all the internal memos and valiant efforts of medical officers within the agency, the FDA persisted in being soft on the manufacturers...
...One patient dropped out, leaving 31 subjects...
...But evidence is accumulating that vaginal sprays pose serious hazards...
...Cupid’s Quiver, for example, features raspberry, champagne, jasmine, and orange...
...On September 27 the FDA promulgated its final restrictions on the use of hexachlorophene in drugs...
...The product was applied to the pubic-vaginal area either two or four times daily...
...Medical Problems If this were merely a tale about the wilder fringes of the beauty industry, we might dismiss the story as one more example of how the American economy keeps people in jobs...
...The boom began when Alberto-Culver beat its competitors to the market and introduced FDS in 1966...
...It may be a while before a better illustration of this truism comes along...
...The agency seemed to be regaining momentum...
...they do not have to warn users to seek medical help if certain symptoms appear...
...Dr...
...Under the FTC’s admittedly cumbersome procedure, this could be a first step toward issuing complaints about decep tive advertising...
...Some 209,000 of them responded...
...To convince women of the need for a product which didn’t exist before 1966, the four leading manufacturers spent over $8 million on advertising in 197 1. A prime target is the youth market...
...What the FDA won’t tell you about FDS by Joseph A. Page When feminists are looking for a good illustration of what’s wrong with American business, they often point to feminine hygiene sprays...
...Meanwhile, the FDA has begun to receive complaints of adverse reactions to a deodorant tampon, and has met with the manufacturer to ask politely for a list of ingredients and safety-test data...
...Doctors stress that routine cleanliness is the best protection against odor...
...This left the Bureau of Foods committed to the requirement of warning labels which the first October 19 memo had proposed as “a less Draconian approach...
...3. Recent serious challenges to the safety of hexachlorophene...
...From a psychological standpoint, a physical standpoint, a cultural standpoint, and a sexual standpoint it would be an understatement to call this a sensitive area...
...Deodorant sprays left the pages of Mademoiselle and attracted government attention because of their enormous commercial success and the numbers of consumer and doctor complaints that followed...
...4. The possibility of masking the need for medical treatment...
...Comment: The company states they found no irritation or other abnormalities which could be attributed to the use of their product...
...Furthermore, if each clinical report form is read, the bias of the examining nurse becomes very obvious as she belittles every positive fmding-attempting to blame it on anything but the feminine hygiene deodorant spray...
...2. The nature of hexachlorophene...
...When Congress, the FDA, and the spray industry are all run by men, they ask, how can women get a fair shake...
...That afernoon, following a conference with Peter Hutt, a decision was made to accept the industry position-demonstrating that the agency doesn’t always act slowly...
...This was at best a partial solution, since neither the FDA nor the companies had yet discovered which ingredient actually caused the irritation...
...The sprays usually contain alcohol, scent, an Joseph Page teaches law at Georgetown University Law Center and is co-author of the Nader report Bitter Wages...
...In typic.al bureaucratic fashion, its response was to hedge...
...When the first vaginal deodorants reached the market in October, 1966, there was no regulation requiring that the companies notify the government of this historic event...
...Representatives of women’s, labor, and consumer groups met with Dr...
...He added that “a representation that a product contains hexachlorophene may well be sufficient to classify it as a drug claim,” but warned that the threat of such a classification would merely induce manufacturers to stop making the claim...
...Emphasis added.] Recent attempts by public interest advocates to investigate test data sent in by Alberto-Culver and the other companies provoked a flurry of evasive, often contradictory responses at FDA and one unusual result...
...John Gowdy of the FDA’s Bureau of Foods, in a memorandum dated November 24, 1971...
...When reluctant regulators administer toothless laws, the result is a charade at the public’s expense...
...He was out to silence the FDA, and he seemed to succeed, for at the conclusion of the m.eeting, Dr...
...Simmons on Sensitivity A subsequent Bureau of Drugs memo added the point that the terms “hygiene” and “deodorant” are misleading “as they [the sprays] in no way promote hygiene (either cleanliness or health) nor are these products proven or accepted deodorants in this area...
...under this ruling, they could keep on using the toxic chemical in the same amounts as before, calling it a “preservative...
...The use of the chemical in cosmetics could continue only if it served as a “preservative” rather than an active ingredient, at a concentration no higher than 0.1 per cent-and only if manufacturers could not find an alternative preservative...
...The industry, which had already planned to remove hexachlorophene from its sprays, was concerned because the ban would prevent it from selling existing stock...
...Benson C. Schwartz of the agency’s Bureau of Drugs concurred, reporting, “The clinical studies submitted are inadequate and not controlled...
...Patients were not restricted as to other medications and douches...
...And so it goes...
...With these facts in hand, the FDA had to confront the problem of what action to take...
...The medical world is generally skeptical of the sprays...
...told readers that Bureau of Foods chief Robert M. Shaffner had predicted that by the time the article was published, the FDA would have issued a regulation requiring warning labels for the sprays...
...On August 12, 1971, Gus S. Kass, vice president of Alberto-Culver, complied with the FDA’s request, and several other companies sent information on consumer complaints, ingredients and testing...
...Only if a cosmetic is adulterated or misbranded can the agency invoke legal sanctions, the most drastic being seizure of the product...
...F-D-C Reports, a trade publication, has quoted an Alberto-Culver official as insisting that the corner has already been turned and that sales of market leader FDS will soon return to 197 1 levels...
...The government has a responsibility to protect the consumer from hazards like these...
...Some critics point to sexism as an explanation for the government’s failure to take the problem seriously...
...The morning the order was published, industry representatives rushed to the agency and met with FDA compliance officers to argue that the propellant should be included in the hexachlorophene level measurement...
...and quite likely in the vaginal area...
...they imply medical benefit in pathologic vaginal problems which are odiferous and should be treated by a physician...
...Shortly after the first request for disclosure, the Alberto-Culver test data was mysterious1.y and “inadvertently” sent back to the company...
...The risks arise from what the sprays do to the sensitive pubic region...
...In short order other sprays joined it, but the real expansion did not come until 1969...
Vol. 5 • March 1973 • No. 1
