Nutritional Supplements Much More Safe Than Medication

Nutritional supplement safety is very high compared to prescription drugs. The number of people who die each year due to nutritional supplements (vitamins and minerals only) is a fraction of the people who die due to medication.

Nutritional Supplement Safety Stats

Deaths Due To:	1999	00	01	02	03	04	05	06	07	08
Alcohol (beverage)	89	82	93	120	98	97	120	10	5	20
Tylenol *	85	99	120	119	147	150	138	110	74	91
Antihistamines	28	30	44	71	64	55	77	16	14	3
Aspirin *	45	52	52	60	59	54	58	14	0	24
Herbal Supplements	12	15	12	4	13	10	13	3	1	0
Gastro-Intestinal (OTC)	1	13	10	16	24	21	29	2	0	1
Vitamins	2	0	0	2	4	3	1	1	1	0
Minerals K=Due to Potassium Fe=Due to Iron Na=Due to Sodium	2	5 K-3	7 K-5	5 Fe-4	8 K-3 Fe-2 Na-2	9 K-7	13 K-4 Fe-3 Na-2	3 Na-2	1 Mg	3 Na-3
Lightning	46	51	44	51	43	32	38	47	45	27

Source: Poison Control Centers Annual Reports
Lightning Statistics (.gov)
* (w+w/o drugs)

During a 1999 Congressional hearing of the Committee on Government Reform, “As for the safety of supplements, an interesting comparison was published last year; 106,000 people die a year from prescription drugs; 42,000 a year from automobile accidents. It is more likely you will be struck by lightning and die in this country than it is that you will die from using a dietary supplement, with just 16 deaths reported last year. We wish to continue to work with the FDA to assure that these numbers do not increase. Research to learn more about drug interactions will help, as well as a better reporting system.”

Government Reform Hearing (search “as for”)

Nutritional supplements are not herbal supplements. Unfortunately, nutritional supplements and herbal supplements are often referred to as one as “dietary supplements”. In the quote above, it was in 1998 that dietary supplements caused 16 deaths, of the 16 herbal supplements caused 12 and nutritional supplements caused 4 of the deaths.

FDA on Nutritional Supplements (.gov)
Nutritional Supplements (.gov)

Each year, an average of 7,000 people lose their lives to pharmaceutical drug side effects. It is well documented that on average 100,000 people a year lose their life to mistakes by doctors and hospitals.

  100,000 Each Year

The Important Difference Between Nutritional Supplements and Dietary Supplements

Dietary supplements can be a supplement of nutrients, a supplement of herbs, or a supplement of both nutrients and herbs. Nutrients are necessary components in body chemistry; over 20 nutrients are necessary to stay alive. The government requires vitamins A and D added to milk and B vitamins added to flour. Herbs are not necessary for body chemistry, are not required to be added to any foods by the government.

When taken in proper amounts nutritional supplements nourish the body. The only real problem with nutritional supplements are iron and potassium supplements. Children find their parents’ iron supplement and either overdose on iron or suffer lethal digestive problems. Why the government just doesn’t require a large warning label or child proof caps on iron supplements is a mystery. Potassium supplements by law can only be sold in 99mg doses to prevent overdosing on potassium, but some people still manage to cause themselves a heart attack from taking too much potassium.

Other than the relatively small amount of nutrients in herbs, herbs contain numerous biochemicals foreign to the human body that interfere with body chemistry and generally are not used by the body at all. Some of these biochemicals interfere with biochemical reactions in a helpful way, but at the same time interfere with other biochemical reactions, causing side affects. For some the side affects are deadly. Like many prescription drugs, herbal supplements are used for symptoms caused by nutritional deficiencies.

The problem with calling nutritional supplements dietary supplements is that herbal supplements cause many more problems and deaths than nutritional supplements. The pharmaceutical industry is constantly begging the government to remove dietary supplements for problems caused by herbal supplements in order to remove both herbal supplements and nutritional supplements – despite the fact that their own products regularly cause several thousands of deaths each year. Why? To increase profits by selling their drugs to people who were helping themselves with nutritional supplements and others with herbal supplements.

The number of deaths caused by herbal supplements could lead to removal of both nutritional and herbal supplement from store shelves when it’s herbal supplements that cause so many more deaths and serious injuries and headlines than nutritional supplements.

Please spend a few minutes informing your Congressman / Congresswoman and Senator you don’t want nutritional supplements removed from store shelves by the FDA, FTC, and the pharmaceutical industry.

Write Your Congressman/Congresswoman
Write Your U.S. Senator
Write Your State (choose “Legislators” at right)

Codex Alimentarius

Government’s Response To Codex Concerns? (.gov)
What Is Codex Alimentari?

Health Claims On Supplement Labels

The FDA doesn’t allow manufacturers to claim a nutritional supplement prevents, treats, or cures any disease, other than deficiency disease, such as pellagra, beriberi, rickets, goiter, and spina bifida. This is because a disease caused by a nutritional deficiency is a deficiency disease. Once it’s proven a deficiency of a nutrient causes a disease, then the disease is a deficiency disease.

Factually, nutrients are necessary for almost all structures and functions of the body to work normally. Factually, most structures and functions require more than one nutrient to operate normally. The idea that long term deficiency of a collection of nutrients does not cause disease is absurd. No doubt many different diseases are caused by different long-term collections of nutrient deficiencies. There’s no money to be made in determining any of these collections, but there is a whole lot of money for the government and taxpayers to save if nutrition was taken more seriously by the government. The medical industry would rather have you believe that illnesses are spontaneous. There is no such thing as spontaneous illness.

Nutritional Product Requirements

For claims about a nutritional product to be legal, they have to comply with the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Code of Federal Regulations (21CFR101.93), and the Federal Food, Drug, and Cosmetic Act (403 (r)(6)).

The Dietary Supplement Health and Education Act of 1994 (DSHEA)

DSHEA was passed unanimously by Congress, largely because in the months before DSHEA was proposed, Congress received more letters about dietary supplement regulation than during the entire Vietnam war.

Here’s a list of opening statements of fact by the government on nutrition:

“Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government

The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies.

There is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis.

Clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods

Healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty

Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures

Promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures.

Reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country

There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health

Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements.

National surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition

Studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs.”

DSHEA (.gov)

Code Of Federal Regulations – 21CFR101.93

21CFR 101.93 is one of many laws on labeling of food, food products, and supplements. It says that within 30 days after marketing a product using a claim about the product, the manufacturer must notify the FDA’s Office of Nutritional Products. In the notification, the manufacturer must certify (sign to it) that its claim about the product is substantiated (significant credible evidence), truthful, and not misleading. It also requires the manufacturer to state along with the claim, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The law (21 CFR 101.93) states that claims about supplements can only be structure/function statements. According to the law, structure/function statements are

“…statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims.”

The law defines disease as,

“Damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”

The law states the, “FDA will find that a statement about a product claims to diagnose, mitigate, treat, cure, or prevent disease if it meets one or more of the [following] criteria,

(i) Has an effect on a specific disease or class of diseases

(ii) Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology

(iii) Has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm

(iv) Has an effect on a disease or diseases through one or more of the following factors:

(A) The name of the product

(B) A statement about the formulation of the product, including a claim that the product contains an ingredient (other than an ingredient that is an article included in the definition of “dietary supplement” under 21 USC 321(ff)(3)) that has been regulated by FDA as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease;

(C) Citation of a publication or reference, if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease, e.g., through placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product’s express claims;

(D) Use of the term “disease” or “diseased,” except in general statements about disease prevention that do not refer explicitly or implicitly to a specific disease or class of diseases or to a specific product or ingredient; or

(E) Use of pictures, vignettes, symbols, or other means;

(v) Belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease;

(vi) Is a substitute for a product that is a therapy for a disease

(vii) Augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases;


(viii) Has a role in the body’s response to a disease or to a vector of disease;

(ix) Treats, prevents, or mitigates adverse events associated with a therapy for a disease, if the adverse events constitute diseases; or

(x) Otherwise suggests an effect on a disease or diseases.”

21CFR 101.93(.gov)
Code Of Federal Regulations (.gov)

Federal Food, Drug, and Cosmetic Act Section 403 (FD&C Act 403(r)(6) – “misbranded food”)

This law states, “…a statement for a dietary supplement may be made if :

(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,

(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and

(C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.

A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.” (Section six of the DSHEA is a reiteration of 403(r)(6).)

Food, Drug, and Cosmetic Act Section 403
Nutrient Content Claims Definitions
Questions and Answers on FD&C 403(r)(6)