National Better Business Bureau on May 29, 1957, setting forth further details about the advertising of Regimen tablets, is attached.

The Post Office Department issued a fraud complaint against the Wonder Drug Corp., and on June 24 the firm signed an affidavit of discontinuance, thereby eliminating mail-order sale of the product. Despite this fact, drugstore sale of the product continues to be vigorously promoted in the name of the Drug Research Corp.

In April, radio advertising was commenced for a product called 7-Day Reducer, with the script reading in part as follows:

Friends: From Government health authorities in Washington, D. C., a new way to reduce without diets, exercise, or dangerous drugs. Now lose up to 7 pounds a week, 15 pounds in 2 weeks, 30 pounds a month, with amazing 7-Day Reducerthe new wonder drug just released for public use by the United States Government. Here, for the first time, is a formula that actually melts away a pound of fat a day, yet is so safe it is used by doctors * * * even given to expectant mothers. It's the first wonder drug of its kind to be awarded official approval by Federal health authorities. Yes; tests by research and Government scientists prove that 7-Day Reducer deadens your appetite *** makes you immune to hunger *** you still eat all the foods you like, but it's just impossible to overeat because your body automatically rejects excess fat-producing calories *** you lose pounds and inches safely, day after day after day. Don't just take our word, or the word of Government scientists who made this wonder drug possible. Prove it yourself on this free trial offer * * *.

In June, the Rhodes Pharmacal Co. began advertising for its product "Trimet" for drugstore sale, with advertising headed as follows: THE MOST EFFECTIVE, SAFE REDUCING TABLET EVER RELEASED FOR PUBLIC SALE

Clinically tested and used for doctors with remarkable results on many patients in treatment of obesity. Works automatically to depress appetite. Lose weight you want to take off-safely, rapidly, more comfortably. Get positive results or money refunded.

The product consists of a 25-milligram tablet of phenylpropanolamine hydrochloride. This advertising also contains a medical proof section reporting 4 case histories of weight losses ranging from 81/2 to 331⁄2 pounds as reported in medical journals. These four case histories represent material which has been extracted and condensed from Dr. Hirsh's 1939 and 1940 articles, with pertinent data omitted. This copy block concludes:

These medical results prove that you, too, can lose weight safely, more easily, thanks to the appetite depressant effectiveness of Trimet tablets, even if all other reducing aids have failed you in the past.

In July, advertising appeared for a product called Curbwate containing "controlene," Nutrition Product Co.'s name for "the wonder ingredient phenylpropanolamine hydrochloride." The advertisement was headed:

New-the most effective safe reducing tablets ever available without prescription. Now lose weight without willpower. United States health authorities release amazing doctor-approved ingredient for sale to public. Take off pounds and pounds as excess fat disappears automatically-or pay nothing.

Another firm has been recently formed to sell a product containing phenylpropanolamine hydrochloride, methylcellulose, and various vitamins and minerals through salesmen on a door-to-door basis. Business opportunity advertising is being submitted to newspapers for distributors to sell the product as a weight reducer. We are currently in the process of developing further information on this enterprise.

We have just learned that still another firm is sending out directmail advertising for a

reducing wonder drug *** just released for sale without prescription by the United States Government. *** You lose up to 29 pounds the first month, up to 43 pounds or more in a reasonable length of time, without going on a diet, without exercise, without giving up the kind of foods you love to eat, without doing a single unpleasant thing.

We are currently attempting to determine the formulation of this product.

There appears to be no end to such promotions. We currently have several new ones under investigation. For example, products called Formula X-42 and Deltron Formula (see exhibit 6, p. 165) are currently being promoted with identical direct-mail fliers, with only the product name and address differing. These fliers are headed:

Lose 20 pounds in 14 days or double your money back-Released for the first time The amazing scientific discovery that melts up to 50 pounds of ugly, deadly fat off men and women.

Again we see the claim that each product—

was proven 100 percent effective in the most dramatic tests in medical history! It will work for you.

It is claimed that Deltron Formula, or Formula X-42, isfoolproof-not one failure has been recorded by the scientists who tested it. You cannot get hungry or feel weak. In fact it actually makes you healthier. On March 1, 1957, the National Better Business Bureau issued a bulletin (see appendix, exhibit 3, p. 150) to advertising mediums and others on phenylpropanolamine hydrochloride, detailing how advertising of the drug as a "no-diet reducing wonder drug" distorts medical research, falsely implies United States Government approval, and exploits the public. The bulletin reported that the drug had been used for the symptomatic control of allegic manifestations of hay fever and bronchial asthma and for many years had been marketed under over-the-counter labeling for this purpose. It was explained that more recently the drug had received some acceptance from medical authorities as an adjunct for controlling appetite in dietary management.

However, the bulletin quoted the 1956 edition of New and Nonofficial Remedies, a publication sponsored by the American Medical Association, as stating:

To depress appetite in obesity, 50 milligrams 2 or 3 times daily before meals for adults.

Thus, it appears that the recommended dosage for depressing the appetite in obesity is a total of 100 to 150 milligrams daily, or 3313 to 100 percent more than the maximum daily dosage permitted by the Food and Drug Administration for over-the-counter sale. The bulletin also explained that the Food and Drug Administration and the American Medical Association were unconvinced of the validity of the claims for appetite depression advanced for the drug in advertising.

The bulletin explained that phenylpropanolamine hydrochloride may not be safe for all persons to take. The Food and Drug Administration requires that any product containing this drug must carry a statement on labeling to the following effect:

Caution. Individuals with high blood pressure, heart disease, diabetes, or thyroid disease should use only as directed by a physician. Do not exceed recommended dosage.

According to medical authorities, these are conditions to which obese persons are especially prone. It cannot be assumed that all persons suffering from such ailments are aware of their condition.

It was explained in this bulletin that, contrary to advertising claims, appropriate dietary restrictions, while maintaining an adequate intake of necessary vitamins and minerals, is the basis of reducing programs generally, with drugs prescribed in selected cases as a "crutch" to aid the user in adhering to a particular dietary program. The bulletin concluded that obesity is recognized as a major health problem and as such its treatment and correction should be accomplished under the guidance of competent medical supervision; that the National Better Business Bureau believes that the dissemination of advertising which deceptively leads overweight persons to believe that they can permanently resolve this problem by taking a "wonder" pill before each meal, with no concern whatever about altering their dietary habits, is false and, therefore, a gross disservice to the public. A copy of the bulletin is furnished.

In connection with our investigation of alleged weight-reducing products containing phenylpropanolamine hydrochloride, the National Better Business Bureau has reviewed a considerable number of published articles concerning the drug; has obtained opinions from certain medical groups as well as opinions of some individual physicians who have published such articles; and has requested each individual advertiser to submit substantiation in the form of competent clinical test evidence that this drug, in the dosage contained in a given product, will depress the appetite of obese users generally to the extent that they will automatically lose weight as is claimed in advertising. We have yet to see any acceptable evidence that the drug, in the dosage permitted for over-the-counter sale, will produce such results as cited previously in this testimony. Even in medically prescribed dosages, the drug is used as an adjunct to dietary measures.

Arthritis preparations: Arthritis is an extremely complicated condition of a serious character. Competent treatment can be prescribed only on the basis of painstaking examination by a properly qualified physician. For this reason, the National Better Business Bureau recommends that no product be advertised to the public for the selftreatment of arthritis. Although there are preparations which afford limited temporary relief from painful symptoms of arthritis in some cases, we believe that any possible benefit offered is far outweighed by the irreparable injury which may be done those who are thus encouraged to forego proper medical atention from the very beginning. The products advertised for the self-treatment of arthritis usually consist of various combinations of analgesic ingredients, the properties

of which have been known to medicine for years. Yet, they are frequently advertised in such a manner as to lead the public to believe that some "new medical discovery" has been made which will be effective in treating their conditions. For example:

A preparation containing sodium gentisate and salicylamide-both having analgesic action similar to aspirin-has been advertised:

*** Announces long-awaited news for all who suffer from arthritis, rheumatism ***The amazing "new wonder drug" hailed on radio by one of America's leading news columnists *** medicine's newest weapon for relief of pain may at long last enable many tortured victims of arthritis, rheumatism, and a host of other painful joint and muscle diseases to return to a comfortable, active, useful life-free of crippling pain and without fear of harmful aftereffects.

A product containing sodium salicylate, acetophenetidin, and caffeine is advertised with the following bold headlines:

Revolutionary new formula acts fast! Take one "golden" tablet tonight and wake up tomorrow morning without arthritis-rheumatism pains *** or pay nothing! Enjoy blessed relief all day *** all night! Famous arthritis doctor discovers new type "golden" tablet. * * * So potent-just two tablets work all day *** all night to relieve arthritis inflammation, stiffness, and crippling disabilities due to pain.

Another product containing sodium salicylate, para-aminobenzoic acid, and vitamin C was offered last winter with advertising headed:

New hope for victims! At last. You may never suffer another pain due to arthritis or rheumatism * * *. Round-the-clock relief now possible * * * medically approved, clinically tested formula prescribed by doctors in thousands of diagnosed cases * ** Now available without prescription at all leading drugstores!

The fact that analgesic products, such as aspirin and similar compounds, afford temporary relief to many sufferers from arthritis is not doubted. What is questioned is the advertising of such products which implies that victims of arthritis and rheumatism generally will be completely freed of pain when such results are not possible.

"Tranquilizing" pills: It appears to us that as a result of the publicity accompanying the development of the new prescription drugs for use in treating emotional disturbances, some proprietary products containing ingredients which have been in common usage for many years, and functioning in a different manner than the new prescription drugs, are now being advertised as "tranquilizing pills." For example:

A product called TR-34 was offered by the North American Stevens Corp. earlier this year in full-page advertisements headed-"Now! A Tranquilizing Pill Without a Doctor's Prescription." The copy further claimed:

Released to you for the first time! An entirely different kind of "calm-down pill" that helps you fight nervousness, fight tension, fight aggravation, headache, and anxiety like nothing you have ever tried before without a doctor's prescription! *** The wonder working ingredients in these pills are being recommended by leading specialists all over America. They are used to fight the terrible, frantic depression caused by constant anxiety! They are given in almost every clinic, hospital, and doctor's office in the world-to men and women of all ages, who need doctor-prescribed help to break the continuous chain of worry, tension, and anxiety that is ruining their lives today!

The advertising also claimed that TR-34 would give the "same kind of blessed relief" as prescription tranquilizers, such as Miltown and Resperine, and that the price of 30 capsules ($2.98) was less than

one-half the cost of prescription tranquilizers. The product was described as

a tiny harmless capsule that you can take anywhere, any time, according to simple directions-and take safely as much as 2 to 4 times a day without the slightest fear of forming a habit!

This product consisted of ordinary triple bromides, phenacetin, and passiflora-passion flower, which has no medically recognized effects. In contrast to the safety claims made in advertising, purchasers of the product found that directions stated:

We do not recommend that you take this product continually over a long period of time.

Directions recommended a specific limited dosage schedule, and contained the following warning statement:

NOTE. Not to be taken by people suffering from kidney disease or mental derangement. Excessive or prolonged use may in some instances lead to skin rash. If nervous symptoms persist, or are unusual, we suggest you consult your physician.

With respect to the claim that the wonder-working ingredients in these pills are given in almost every clinic, hospital, and doctor's office in the world, we were advised by medical authorities that, on the contrary, most physicians, aware of the toxic potentialities of chronic bromide administration, have avoided use of this drug; that passiflora is used almost not at all.

It is not suggested that taking a bromide to relieve an occasional headache will be dangerous. However, this and similar products are advertised to alleviate persistent nervous conditions, which may be complicated. Medical authorities warn that continued use of bromides carries with it the definite possibility of cumulative poisoning. Persons using a bromide-containing preparation may unwittingly continue to take it for the relief of the very symptoms which the bromide itself is producing. Mental disturbance is the most serious consequence of bromism, although other grave effects can occur. Bromides should not be used for unlimited periods, and are definitely more hazardous for persons on a low-salt diet or those with a mental disturbance. For these reasons, it is the opinion of these authorities that unsupervised use by the general public of such a product as TR-34 is potentially dangerous.

As for the claim that the price of $2.98 for 30 capsules was less than one-half the cost of prescription transquilizers, we found that the leading prescription transquilizers were available in quantities of 30 at prices ranging from $3 to $4.

On May 13, the Post Office Department issued a fraud complaint against the North American Stevens Corp., and on the following day the firm signed an affidavit of discontinuance to become effective as of July 15.

During the past 2 years a product called Orbacine-initially marketed under the name of "Cerene"-which contains ammonium bromide, potassium bromide, and niacinamide hydrobromide has been promoted for mail-order sale. Small advertisements in newspapers and magazines refer to the formulation as a new discovery which calms and tranquilizes nerves and is never habit forming, and solicit readers to write for further information.