As you ponder the countless multitude of nutritional supplements on the market, it would be wise to consider their safety and efficacy.

The Pure Food and Drug Act, passed by Congress in 1906, was initially concerned with making sure ingestible products were labeled correctly, but the labeling requirement evolved to outlawing certain products that were not safe, followed by outlawing products that were safe but not efficacious.

The act paved the way for the eventual creation of the Food and Drug Administration, but was repealed and replaced by the much more comprehensive Food, Drug, and Cosmetic (FD&C) Act of 1938.

The FD&C Act defined and divided consumer products into different categories including food, drugs, medical devices, food additives and dietary supplements. Since 1962 drugs and food additives have required approval.

Foods have never required approval. You could sell food on the basis of the foregone conclusion that it was good for you. But in the 1980s food companies started making health claims, which raised the question of the distinction between food and drug.

What followed was a debate on food labeling as the public began asking for government help to sort out which claims were true and which were not. This led to the passage of the Nutrition Labeling Education Act in 1990, which stated that foods could make health claims but the claims had to be approved by the FDA.

Unable to decide whether dietary supplements should require approval, Congress said in the Nutrition Labeling Education Act that the FDA should decide: Should foods and dietary supplements have the same standards, or should dietary supplements be treated differently? The FDA made the decision that foods and dietary supplements should be treated similarly.

That decision set off an intense lobbying campaign by supplement manufacturers. Congress likewise got tons of mail expressing anger and fear that FDA was going to require prescriptions for vitamins and other supplements. A similar scare rippled through the country again in 2007.

As a result, in 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA) that restricts the FDA's authority over supplements, as long as companies are careful not to claim that their products treat, prevent or cure disease. They can, however, make claims that supplements affect the structure or function of the body, for example to say that glucosamine “;promotes joint health.”;

If this appears to have solved the problem, many people think that it only muddled the issue and weakened the power of the FDA to approve and regulate nutritional supplements. Under DSHEA most supplements get less scrutiny from the FDA than a pack of cough drops, placing as it does the responsibility on the supplement manufacturer to ensure the safety of its products.

A study done in 2001 found broad public support for greater governmental regulation of dietary supplements than is permitted by DSHEA. The researchers found that a majority of Americans supported pre-marketing approval by the FDA, increased oversight of harmful supplements and greater scrutiny of the truthfulness of supplement label claims.

Yet most Americans believe that supplements must be approved by a government agency before they can be marketed, that supplements must list potential side effects on their labels and that supplement labels cannot make claims of safety without scientific evidence. None of that is true.