Experts Critical of New FDA Order; Pharmaceutical Companies Irate
Contents in in this issue:
- “Nutritional Experts Critical of New FDA Order,”
- “Pharmaceutical Companies Irate.”
The following is a transcription of the September 1966 issue of Dr. Royal Lee’s Applied Trophology newsletter, originally published by Standard Process Laboratories.
Nutritional Experts Critical of New FDA Order
Here is the label disclaimer statement FDA wants on all bottles of food supplements:
“Vitamins and minerals are supplied in abundant amounts by the foods we eat. The Food and Nutrition Board of the National Research Council recommends that dietary needs be satisfied by foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements.”
Professor Thomas H. Jukes, lecturer in nutrition at the University of California in Berkeley, advised the FDA, “The first sentence is a generalization which does not apply to individual cases. I do not think that any professor of nutrition would give a passing grade to a student who made such a statement.” And in opposition to the last sentence he remarked, “There is a strong scientific basis for recommending routine use of dietary supplements to make sure that overt signs and symptoms do not develop in persons who have unrecognized special medical needs.”
Dr. M.K. Horwitt, of Elgin State Hospital in Elgin, Illinois, pointed out that humans may achieve increased efficiency and resistance to disease as the result of vitamin supplementation, in addition to better growth.
Dr. George M. Owen, pediatrician at Ohio State University Children’s Hospital, said that the first sentence is erroneous in that “it is mistakenly assumed that most people in this country receive a diet adequate in all respects, simply because of an abundant food supply.” He further commented, “It is discouraging to see the government formulate regulations pertaining to matters for which the scientists have not yet provided definite information.”
Dr. Floyd J. Filer Jr., Professor of Pediatrics at Iowa University Medical School, objected to the label statement and criticized the proposed FDA regulations for the reason that “they have little or no working relationship to the broad area of infant feeding.” He further stated, “One cannot legislate ‘good’ nutrition,” and suggested FDA revise the document so that “the complexities of infant nutrition can be managed by the physician and all infants profit in a nutritional sense.”
Dr. Roger J. Williams, Director of Clayton Foundation Biochemical Institute and Professor of Chemistry at the University of Texas, stated, “My entire life’s work in nutritional research will be seriously affected adversely if the order published in the Federal Register of June 18, 1966, pages 8521–7, is made effective without modification. This is stated to be an adequate basis for registering objections. If the public welfare was not also involved, however, I would not be inclined to state my case…On behalf of millions of individuals whose bodily needs may not be met on the basis of calculated averages, I respectfully request a hearing…”
In reading the required statement, one presumes that the National Academy of Science–National Research Council, the private group that advises the Federal Government on scientific and technological matters, had concurred in this statement. However, we find Dr. W.H. Sebrell Jr., Chairman of the Committee on Recommended Dietary Allowances of the National Academy of Science–National Research Council, and a professor of public health nutrition at Columbia University, has termed the statement “objectionable and misleading.” He said there is “No relevance” to the claim of sufficient vitamins and minerals in food for many individuals. He also protested that the list of recommended dietary allowances published by the FDA has assigned “arbitrary figures.”
United States Department of Agriculture Assistant Secretary George L. Mehren wrote the FDA that the most recent nationwide survey reveals 48 percent of American families have diets that do not meet the previously recommended dietary allowances or nutrient levels. He advised the FDA that the proposed label statement, “Vitamins and minerals are supplied in abundant amounts by the foods we eat,” was both inaccurate and misleading.
Dr. LeRoy Voris, executive secretary of the Food and Nutrition Board, recently stated that he doesn’t know where the FDA got the exact phrase that his organization “recommends that dietary needs be satisfied by foods.”
Adelle Davis, the author of many books on nutrition, said: “If the proposed FDA regulations go into effect, they will set nutrition back fifty years.” She also cites an instance of paying a 5,400 percent increase on a prescription purchase compared to the same vitamin purchased over the counter. She concludes, “Far from having money, FDA regulations will make the cost of supplements prohibitive to thousands of people.”
Legality of Said Order
Attorneys for many affected businesses and representative organizations have filed legal briefs challenging the validity of the new regulations and requesting that a hearing be held.
Many issues have been cited as a basis for the hearing, a few of which are herewith stated.
- The lack of scientific evidence supplying any basis on which to dictate to the American people what they can eat.
- Involvement of the First and Fifth Amendments of the Constitution of the United States* and the lack of statutory authority under the Federal Food, Drug and Cosmetic Act, as amended, to issue the said Order, if in effect having the effect of criminal law to dictate the the nutritional requirement of every individual American.
- The Federal Food, Drug, and Cosmetic Act is a punitive Act without proper statutory or judicial safeguards as provided under other Acts, which require that the government prove the guilt of a defendant, who is presumed to be innocent until conviction or sentence, and every appeal has been ex In other serious offenses it is necessary to prove knowledge and intent to commit an alleged crime. It is not so under the said Federal Food, Drug, and Cosmetic Act, or as to matters covered by this Order.
- Adverse effect of the Order because of the strict, unreasonable, and unwarranted limitation of the number of vitamins and minerals an American citizen can buy and consume without unnecessary expense of a prescription, and the added attendant costs of a doctor’s charge.
- Further, the regulations could deny to the American consumer the freedom of choice of his diet by restricting his right to buy and consume nutritional food and food supplements which are not adulterated, dangerous, deleterious, or toxic.
- Said Order would adversely affect the rights and health of individual United States citizens, who best know their special dietary requirements, or who use supplements by reason of an existing physical, physiological, or pathological condition.
- The obvious effect of the Order would be to foster the power of a medical monopoly, increasing prices rather than improving or protecting the health of Americans who need and use foods for special dietary purposes.
*First Amendment relates to Freedom of Speech. Fifth Amendment relates to due process of law.
Dictatorial? These controversial regulations prohibit statements such as:
- Vitamins or minerals can prove helpful to treat or prevent disease.
- A diet of ordinary food may not supply adequate vitamins and minerals.
- “Significant segments” of the population may be suffering a dietary deficiency.
- Poor soil quality can be responsible for lowered food value.
- Storage, processing, transporting, or cooking food can cause loss of various vitamins and minerals.
Apparently, it is desired to give the force of law to what are only opinions, not backed by scientific facts. This “smacks” all too much of the “mythology” in regard to dietary deficiency as long promoted by certain commercial interests and followers of their propaganda, such as Dr. Frederick Stare. In one of his more recent columns, Dr. Stare advised that Dr. James Goddard, Director of the FDA, was his student at Harvard University.
In regard to these regulations, Attorney Kirkpatrick W. Dilling, a lawyer specializing in nutrition and health problems and general counsel of the National Association of Food Supplement Manufacturers and Distributors, stated, “In my opinion, the proposed regulations would establish Commissioner Goddard as a ‘diet czar,’ depriving the food supplement industry and consumers of special dietary foods, of precious and cherished liberties.” Another lawyer specializing in food and drug laws said that the “FDA has gone way beyond its normal area of jurisdiction.”
Congress Too Objects
Congress has become cognizant of this fact, and Rep. David King of Utah has submitted Concurrent Resolution No. 807 in the House of Representatives 89th Congress of the United States, Second Session. The protest resolution reads as follows:
Resolved by the House of Representatives (the Senate concurring) That, because any sweeping changes in regulations relating to labeling and content of diet foods and diet supplements would have a substantial impact on the health and welfare of the people of the United States and are, therefore, a matter of basic national policy that should be determined by the Congress, it is the sense of the Congress that the regulations ordered by the Food and Drug Administration of the Department of Health, Education, and Welfare on June 17, 1966, with respect to the labeling and content of diet foods and diet supplements should not be made effective or enforced until the Congress has by law conferred the authority to make such regulations on the Department of Health, Education, and Welfare.
Concurrent Resolution No. 807 states in effect that Congress is the lawmaking body of our representative government and that it is not abrogating its vested rights to any agency of the government.
As noted, many nutritional scientists, manufacturers, and distributors of food supplements have filed briefs with the FDA protesting this new order in its present form. Also, thousands of consumers have joined in the protest and requested their Senators and Representatives in Congress to protect their basic rights and personal freedom as citizens. We understand many protests have been registered in regard to the possible threat to the health and welfare of our country.
All protestors seem to agree that the FDA has been misinformed regarding the food order as published and that nothing less than a completely new draft of these regulations will be acceptable to the general public. Many state that the constitutionally guaranteed rights and freedom of every citizen must be respected by all government agencies.
For, as Patrick Henry said, “The great and direct end of government is liberty. Secure our liberties and privileges and the end of government is answered. If this is not effectually done government is an evil.”
Pharmaceutical Companies Irate
The crux of the FDA’s position is that a healthy person who eats a normal diet doesn’t need extra vitamins or minerals and that many products containing them merely confuse him and waste his money.
E.R. Squibb & Sons, Inc., said in a statement Friday: “The requirements for specific nutrients vary widely, not only from person to person, but also in the same person from time to time. It isn’t in the interest of the public health to attempt to define them in terms of the average person on an “ordinary diet.” Squibb also argued that “supplemental vitamin therapy is a means of protecting the individual against the development of vitamin deficiency states and is a means of maintaining normal tissue reserves against the demands of unusual stress situations, such as illness, injury, pregnancy, and inadequate nutrition. A regulation which limits the availability of such vitamins isn’t advisable.
—Reported in The Wall Street Journal, June 20, 1966.