In the Matter of the Complaint Against SCIENTIFIC INTERNATIONAL, INC., P. O. Box 25147 at Houston, TX 77005 and SCIENTIFIC INTERNATIONAL, INC., 5215 Yoakum Blvd. at Houston, TX 77006 P.S. Docket No. 6/82 July 31, 1978 Quentin E. Grant Administrative Law Judge Appearance for Complainant: Daniel S. Greenberg, Esq. Law Department U. S. Postal Service Washington, D.C. 20260 Appearance for Respondent: Katz, Paller & Land by Jack Paller, Esq. 400 Colony Square, Suite 1633 Atlanta, GA 30361
In a complaint filed on March 21, 1978, complainant charged respondent with engaging in the conduct of a scheme or device for obtaining money or property through the mails by means of false representations in violation of 39 U.S.C. 3005.
Specifically, the complaint alleged (paragraph II) that by means of advertisements respondent represents, directly or indirectly, by means of affirmative statement, implication, or omission, in substance and effect:
"(a) That use as directed of 'FORMULA #24' will stop hair loss;
"(b) That the user will experience a significant decrease in hair loss after the first treatment with 'FORMULA #24.'
"(c) That use as directed of 'FORMULA #24' will cause the user to grow new hair;
"(d) That use as directed of 'FORMULA #24' will effect the results enumerated in subparagraphs (a) through (c), supra, even if the hair loss is due to male pattern baldness;
"(e) That use as directed of 'FORMULA #24' will effect the results enumerated in subparagraphs (a) through (c), supra, for both males and females, irrespective of the cause of the user's hair loss;"
and that such representations are materially false in fact.
At respondent's request the hearing location was changed from Washington, D.C. to Houston, Texas. Following continuances resulting from respondent's motion therefor and lack of hotel accommodations in Houston, a hearing was held on May 25, 1978, at which both parties presented evidence. The parties, after additional continuances requested by the parties, have filed proposed findings of fact and conclusions of law all of which I have considered in arriving at my decision.
1. Based on complainant's exhibits CX-1(a) through CX-7, I find that respondent is engaged in a scheme for obtaining money or property through the mails for its product, Formula #24.
2. Respondent makes the representations alleged in paragraph II of the complaint as to the product Formula #24. This is admitted at page 3 of respondent's proposed findings of fact and conclusions of law.
3. Formula #24 (CX-7) is basically a shampoo (Tr. 30) which, according to its label, contains water, ethylenediamine- tetraacetic acid, sorbitol, tar oil, wheat flour, and sodium laureth sulfate. A new formulation of the product (hereinafter called the new product) was received in evidence (RX-2) based on the assertion of respondent's counsel that it is the product sold by respondent starting one week after complainant's test purchase (Tr. 53). According to its label, the new product contains water, sodium citrate, sodium dihydroxy-ethylglycinate sodium di-isobutyl napthalene sulfonate, and disodium monoundecylenamid mea sulfosuccinate. The new product is also, essentially, a shampoo (Tr. 57).
4. Dr. William R. Knowles, a well-qualified doctor of medicine, specializing and board certified in dermatology (Tr. 8-10), testified for complainant. Dr. Knowles testified that the hair shaft is composed of cells which have been converted from living cells into specialized dead cells protruding through the epidermis. Referring to the diagram received in evidence as CX-9 (Tr. 11), he explained that it is the hair bulb, inside the scalp, which is the growing part of the hair. It surrounds the papilla, which is 3/16 inch deep in the scalp, and which is the sole source of nutrition and blood for a given hair follicle (Tr. 12-13).
He testified that average scalp contains approximately 100,000 hair follicles, each of which functions independently of the other. There is a rotational sequence in normal hair growth -- normally 90% of the follicles are in the growing phase, which lasts for a period of 2-6 years; 8-11% are in the resting phase, which lasts for a period of 3-9 months, and 1-2% are in the transitional phase. A loss of approximately 50-100 hairs per day, as the hairs fall out of follicles about to go into the resting phase, is considered normal. An abnormal general loss of hair is usually a reflection of some metabolic disturbance (Tr. 13-14).
5. Dr. Knowles testified that temporary loss of hair can be due to any of several causes, each of which must be individually diagnosed. A relatively common condition called alopecia areata causes temporary hair loss, and corrects itself without treatment in 90-95% of the cases in 6-12 weeks after the cause of hair loss is removed. Although the causes of alopecia areata are unknown, there is a significant correlation between the appearance of this condition and extreme emotional stress such as that brought on by divorce, death in the family, or severe financial reverses. These will often result in development of alopecia within 2-6 weeks after such occurrences. For those cases that don't correct themselves, treatment would include injection of steroids (Tr. 18-19).
6. Dr. Knowles also testified that temporary hair loss can be caused by anything that disturbs the normal metabolism of the body, such as a crash diet; it can also be due to certain skin diseases such as psoriasis and, especially, seborrhea (Tr. 17, 18). He explained that, normally, the sebaceous gland (the mushroom-shaped object approximately 1/3 of the way down the hair shaft on CX-9) secretes at a fixed rate, with the hair shaft acting as a wick, permitting the secretions to flow out of the hair shaft and onto the surface of the scalp. However, nervous tension, stress, and pressure may result in the closing off of the sebaceous gland so that the sebaceous material is not released. When this happens, bacteria will begin to break down the material that is in the gland (Tr. 24, 25). The gland continues to secrete and, if it can build up enough force, sebaceous material will enter the hair shaft, travel up the hair follicle, and become deposited on the scalp, causing the scaling known as seborrhea. When the oil is finally forced up onto the scalp, it is irritating because of the changes caused by the bacteria. The length of time the tension or stress lasts determines to some degree how severe the seborrhea is (Tr. 24, 25).
While the irritation or inflammation of the scalp and the scale and greasy secretion associated with severe seborrhea can cause some hairs to fall out of their follicles, this loss is temporary, in that the hair-growing apparatus itself is not harmed, and the condition does not prevent regrowth (Tr. 25, 26).
Treatment of seborrhea involves alleviation of the stress causing it, if possible. Additionally, ionizing radiation from a Grenz ray may be used to loosen the scale and allow the scalp to heal more quickly. Lastly, depending upon the condition of the scalp, a mild shampoo or a very mildly medicated shampoo might be recommended. The use of the shampoo alone, without other treatment, will relieve the symptoms (i.e., the debris), but not the cause. It will not cut down on the hair loss, inasmuch as it is the basic process of seborrhea which causes hair loss; removal of the debris at the surface does not correct the problem down in the sebaceous gland (Tr. 26, 27).
7. As to permanent hair loss, Dr. Knowles testified that both males and females can inherit a type of hair loss. Male pattern baldness is the most common form of permanent hair loss in men. When one considers all of the varying degrees of baldness, from very mild thinning to overt baldness, he estimated that roughly 30% of balding men suffer from male pattern baldness. Where the front and top of the scalp are bald, and a fringe of hair remains, this appearance is the "hallmark of male pattern baldness" (Tr. 15-16). He explained that in this condition the normal variation between a long growing period and a short resting period is disturbed so that the hair is not rapidly replaced as it falls out. Consequently, over several months to several years, the hairs fail to grow and the hair follicle in that area shrinks, then atrophies, and ultimately cannot even be found when a scalp biopsy is made (Tr. 22). He pointed out that the volume of hair lost is not consistent -- the victim will lose a great deal of hair, the hair loss will taper off, and then start again (Tr. 177).
8. Other causes of permanent hair loss in men and women include repeated use of chemotherapeutic agents; too much tension on hair, use of hot irons; continual plucking of hair; and accidents in which scars affecting the hair follicle are produced (Tr. 20-21).
9. Dr. Knowles stated that a diagnosis of the cause of the hair loss must be made before proper treatment can be commenced. Inasmuch as failure to regrow generally, as opposed to locally, is usually due to a metabolic condition, hair loss is often a symptom of a metabolic disease which must be treated. As to causing hair to regrow, treatment of local, temporary hair loss, such as alopecia areata or that associated with seborrhea, as described by Dr. Knowles, is set forth in Findings of Fact Nos. 5 and 6, supra . Where the hair loss and failure to regrow is caused by scarring, it may not regrow, although it may be possible to transplant hair to that area (Tr. 22, 27-29).
10. Dr. Knowles stated that there is nothing specific in the way of a medication in Formula #24, and that while its use would remove the sebaceous secretions which have collected on the surface of the scalp, such action would have no effect on the loss of hair due to sebaceous secretions.
11. Dr. Knowles testified that the use of Formula #24 will not stop hair loss (subparagraph II(a) of the complaint); that the user will not experience a significant decrease in hair loss after the first treatment (subparagraph II(b) of the complaint); that the use as directed will not cause the user to grow new hair (subparagraph II(c) of the complaint); that the use as directed will not cause a user with male pattern baldness to overcome that problem, and that the answer would be no different if one were to consider male hair loss as opposed to female hair loss (subparagraph II(d) of the complaint). When Dr. Knowles was asked whether the change in ingredients as reflected in R-2 would in any way change the testimony he had given, he testified that it would not. He testified that R-2 is basically a shampoo, as is CX-7 (Tr. 56-57).
12. Dr. Knowles' testimony is in conformity with the consensus of informed medical opinion (Tr. 33).
13. Respondent's principal witness was Refugio Escobedo who has been in the hair dressing profession for over 20 years. His knowledge relating to the scalp and to hair has been derived from information put out by the Redken Company, and from various hair styling experts (Tr. 64-65). Mr. Escobedo was not competent to discuss medical questions. He testified solely as a test administrator (Tr. 67, 72) of a test run on Formula #24 at respondent's request.
14. Although Escobedo had originally planned to use 8 test subjects, and would have preferred to use at least 12, he ultimately used only 3, a photographer, a minister, and a car salesman (Tr. 66, 68-69). The test procedure was basically as follows:
The test subjects shampooed their hair using the "house" shampoo for 3 or 4 days, after which time the "before" pictures (discussed infra ) were taken. In order to establish some basis for comparison, the hair lost during these shampoos was to be taken from the shampoo bowl, counted, and saved during each day of the test. After the three days of shampooing with the house shampoo, the subjects were to come in twice a day, once in the morning to have their hair shampooed, as described above, and once at night to have Formula #24 applied. However, because the amount of hair lost during the shampooing was erratic, it was not counted after "about a week" (Tr. 68-70, 150-51).
15. Escobedo's testimony was confused and confusing principally because he seemed to be unable to distinguish between the actual growth of hair and the appearance or illusion of growth. He admitted that his main concern was to determine whether there was an appearance of greater density of hair at the end of the test than before (Tr. 94, 95). He admitted that he couldn't see the actual growth of hair over the 14-day period (Tr. 116) except on a bald head (Tr. 137). He stated that he was not hired to see if there was any visible evidence of new hair growth based on close examination of each head (Tr. 117, 118). Rather, he had been asked to base his determination as to whether the product had produced a difference by looking at "before" and "after" pictures (Tr. 95). Comparing the "before" and "after" pictures he concluded as to one subject, the car salesman, that there was greater density after use of the product (Tr. 89, 100, 101). By touching and looking at another subject's head (the photographer), he concluded that there was more density and more sturdiness after use of the product (Tr. 132, 137, 159, 160). He found it difficult to evaluate the results of use of the product on the hair of the minister and the car salesman (Tr. 133). They seemed to say, according to Escobedo, that "something was happening" (Tr. 133, 134). As to the minister and the car salesman, Escobedo candidly stated that he could not form an opinion as to whether the hair was growing or not growing in only 14 days (Tr. 145).
16. Respondent's counsel testified that as an accommodation to his client and, as a desperation move, he agreed to use the product on his own scalp in a minimal control study which had continued for a period of about 3 1/2 weeks up to the time of the hearing. For four days prior to use of the product, Mr. Paller counted hair losses during shampoos of not less than 200 hairs. The first day he used the product the count decreased to 87 hairs and never exceeded 50 hairs thereafter. He attributed the substantial lessening in hair loss to his use of Formula #24 (Tr. 163, 164).
17. In rebuttal testimony, Dr. Knowles testified that on the basis of his examination of the before and after photographs of the photographer's scalp he could see no increase in density of the hair, meaning the number of hair shafts per unit area (Tr. 171, 172, 174, 175).
18. As to Mr. Paller's testimony concerning a large decrease in the number of hairs lost in his daily shampoos from the beginning of his use of the product, Dr. Knowles' opinion was that such decrease was consistent with a coincidental loss in volume of hair loss in the normal fluctuations associated with male pattern baldness or with reduced stress and worry concerning hair loss. In Dr. Knowles' opinion, if in fact Mr. Paller and the photographer who participated in respondent's study did experience some increase in hair growth while using the product, this would not constitute scientifically valid proof of the efficacy of the product (Tr. 177-179).
1. Respondent is engaged in the conduct of a scheme for obtaining money or property through the mails by means of representations substantially as characterized in the complaint.
2. Although male pattern baldness is not specifically mentioned in respondent's advertisements as one of the types of hair loss which Formula #24 will stop and reverse, the representations specifically made are sufficiently broad to encompass that type of loss.
3. The testimony of respondent's witness, Escobedo, is so riddled with confusion, inconsistency, and uncertainty as to render it and the photographs introduced through him largely worthless. The testimony of respondent's counsel as to his experience during the use of the product is not, considering Dr. Knowles' expert medical opinion, valid proof of the efficacy thereof.
4. Although the burden was on complainant to prove the allegations contained in the complaint, it was incumbent on respondent to counter such proof following its introduction. In this connection, I cannot fail to note respondent's failure to offer proof concerning the controlled study of the product and substantiating medical documentation mentioned in respondent's motion for continuance of the hearing, dated April 13, 1978.
5. Based on the testimony of the well-qualified Dr. Knowles, which is in conformity with the consensus of informed medical opinion, I conclude that use of Formula #24 will not produce for most users the results represented and, therefore, that such representations are materially false in fact.
6. An order pursuant to 39 U.S.C., 3005, in the form attached should be issued.