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Sweetener is deemed to be dangerous

By an order of the U.S. Food and Drug Administration, cyclamates were ordered removed from the GRAS (generally recognized as safe) list of food substances. However, a later order noted that the Medical Advisory Group on Cyclamates, established by the Assistant Secretary for Health and Scientific Affairs, had reviewed all available data on cyclamates and unanimously agreed that under appropriate medical management of diabetics and patients, whose health depended on weight reduction and control, ‘Cyclamates provide medical benefits which outweigh their hazards.’ The report recommended that cyclamates be made available for such patients on medical advice and on a non-prescription, drug-labeled basis.

On August 24, 1970, an order signed by the Commissioner of Food and Drugs and published in the Federal Register revoked drug-labeling for cyclamates, based on a new report by the Medical Advisory Group, which concluded that ‘in the absence of adequate evidence of safety and effectiveness, continued sale of cyclamate-containing products with drug labeling cannot be permitted.

It is not within the court’s competence to decide whether the Food and Drug Administration order resulted from intense lobbying by sugar interests as charged by the Defendant or came about only after public pressure and because of the Food and Drug Administration’s procrastinations and prevarications and because of evidence that cyclamates caused bladder cancer, birth defects and mutations in test animals. Suffice it to say that the decision to ban cyclamates was taken in full accordance with the authority vested in the Food and Drug Administration.

At the hearing before the Court, the Executive Vice President of the Packing Corporation testified that the Defendant doctor wrote him if he could make available for many patients who because of their desperate medical problems of diabetes and low blood sugar cannot function without a palatable artificial sweetener the old cyclamate sweetener that use to be called ‘Par-Ev’ providing the patients would go to his facilities in person.

The Defendant doctor went on to authorize the use of his name on the labeling so that an interested observer can know that it is done for medical reasons. He considers this a service to his patients and he is in no way interested in any form of financial remuneration.
The Packing Corporation pleaded guilty to the same violations charged against the Defendant doctor and was fined $5,000.00.

At the hearing, the obese patient testified that when he became a patient of the Defendant doctor, he was diagnosed as a diabetic and told him to use a sweetener containing cyclamate. The patient asked the Defendant doctor whether the sweetener was bad and the Defendant doctor replied that it’s good for his digestion.

He received a price list for the Defendant doctor’s sugar substitute, containing instructions to make a check payable to the Packing Corporation, and promising delivery of mail orders within three weeks. At the end of the price list appear the name of the Defendant doctor and the Packing Corporation’s name and address. The obese patient received the recipes previously mentioned and when he inquired about more recipes, the Defendant doctor suggested that he buy his book.

The Health Sanitarians testified that the Executive Vice-President of the Packing Corporation led him to a room in the plant where the Defendant doctor’s Artificial Sweetener was stored in 5-lb. bags. He embargoed a little less than 500 lbs. of the substance on February 21, 1973, and destroyed the embargoed sweetener on May 22nd. There is no evidence that the Defendant doctor shared in the proceeds of the sales by the Packing Corporation.

The Defendant doctor moved to dismiss on the grounds that he did not pack, possess, sell or offer to sell the forbidden sweetener.

His attorney stated at the end of the hearing his client is a prescribing by a doctor and that is not a violation. The doctor has a right to prescribe. Perhaps there may be a question as to the ethics of a doctor to prescribe that which has been banned as dangerous food additive or drug by the F.D.A. But ethics does not play a part on the case. The question is whether he violated the Health Code, and more particularly, those sections set forth in the summons, and that evidence does not exist.

In his Memorandum of Law, the Defendant asserts that the prosecution addressed itself to the question of whether the Defendant doctor offered to sell the cyclamates. But the prosecution asserts, the Defendant made no offer to sell but merely suggested, recommended and prescribed. It was the Packing Corporation which offered the cyclamate for sale. The Packing Corporation was the seller and the patient was the buyer.

The only act of which the Defendant can be found guilty is the impropriety of recommending to his patients an artificial sweetener containing cyclamates, which had been banned by an order of the Food and Drug Administration.

The defense position is as deficient in substance as cyclamate is lacking in nutritional value, for there is sufficient evidence that the Defendant acted in an accessorial capacity.

In his book, the Defendant published a recipe and one of the ingredients of which is artificial sweetener containing cyclamates, equal to 30 teaspoons of sugar. A footnote, connected by an asterisk to the title of the recipe for the delicacy, reads: ‘For those of you who have been foresighted or fortunate enough to have kept a supply of cyclamate sweetener on hand we are including the recipe which throughout the years has been our most successful.’

The Defendant’s conduct is not merely incidental to the offense of the Packing Corporation’s sale of the sweetener but forms the nexus between the Defendant’s patients and the purveyor of the substance. He fathered the plan, arranged with the Packing Corporation to service his patients and distributed price lists and permitted use of his name on the label.

The Defendant relies on a related case to sustain his contention that willfulness was a necessary ingredient of the information and of the proof required at the hearing. He asserts that Public Health Law prescribes imprisonment for one year or a fine not exceeding $2,000.00 or both for a person who willfully violates any regulation established by a public office or board where no other punishment is prescribed.

In sustaining a jury verdict for the Complainant, the Court of Appeals held that the jury was justified in concluding that the Defendant had no reasonable cause for believing in the truth of the charge he made in the criminal law violation proceeding.

Although the Court finds adequate evidence of willfulness to warrant the Defendant being held for trial, the Defendant would be answerable even if the evidence of willfulness were absent. For, although Public Health Law provides punishment by way of a maximum fine of $2,000.00, or imprisonment for one year, for a person willfully violating any regulation established by a public office or board under authority of the health laws, where punishment for a violation is not otherwise prescribed. The New York City Charter provides that any violation of the sanitary code shall be treated and punished as a misdemeanor.

The court finds that the Defendant doctor must be held for trial on charges of violating the New York City Health Code.

Medical professionals should be the person to make sure that every food and drug that people put in their mouth are safe and healthy. If your doctor prescribed something that could benefit his bank account but give risk to your well being, consult the NYC Criminal Lawyer or the NY Drug Attorney from Stephen Bilkis and Associates.

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