Almost everyone at one time or another has taken dietary supplements. Some people take them to obtain food nutrients lacking in their diet, others take them to compliment or derive more benefits from their food intake, and many people take them because their doctor recommends it.
What then are dietary supplements? Are they safe and do they really work as advertised? Are there any government regulations over what constitutes dietary supplements?
Definition and Classification of Dietary Supplements
Before defining what dietary supplements are, let us first establish that they go by many names. Some of these names include:
- Dietary supplements
- Nutritional supplements
- Health or food supplements
The U.S. Dietary Supplement Health and Education Act of 1994 (DSHEA) issued an umbrella definition as to what constitutes dietary supplements. To this extent, a dietary supplement is:
- A product that contains dietary ingredients such as vitamins, minerals, amino acids, herbs, or other botanical ingredients
- A product that supplements diets by increasing overall dietary intake
- A product containing concentrates, metabolites, constituents, extracts or combinations of these and ingested in the form of a capsule, powder, softgel, or gelcap and not represented as ‘food replacement’
- A packaged food supplement duly labeled as a “dietary supplement”
Based on the above, it is obvious that dietary supplements contain nutritional ingredients that boost the intake and absorption of food and make them more beneficial to the body.
Since dietary supplement products are not categorized as drugs, their labels must include a disclaimer that the U.S. Food and Drug Administration (FDA) has not evaluated any claims of benefits, and that the product “is not intended to diagnose, treat, cure or prevent any disease.”
History of Dietary Supplements
The actual history of dietary supplements is unclear; however, Catherine Price in her book ‘Vitamania: How Vitamins Revolutionized the Way We Think About Food’ revealed that mention of “vitamins” first appeared in print in June, 1912.
Over time, the scientific community discovered a total of 13 vitamins deemed as necessary for personal health.
Having identified the importance of vitamins for physiological functions and overall health, the general public began to accept their basic importance to well-being. To this extent, medicine manufacturers began to tap into the awareness of vitamins for advertising and marketing purposes.
With time, the popularity and acceptance of vitamins rose among the people and product marketers capitalized on this development by labelling many health products as containing one type of vitamin or the other.
“Vitamins’ amazing ability to prevent devastating deficiencies has also helped to create our modern obsession with isolated dietary chemicals – the assumption being that if food contains vitamins, then it must contain other miraculous chemical compounds as well.” – Catherine Price
Jump forward a few decades, and you have health companies manufacturing whole products allegedly composed of nutritional supplement formulations.
How the Government Began to Regulate the Production and Consumption of Food Supplements
There are now government regulations dictating the production, marketing and consumption of food supplements. The U.S. Food and Drug Administration (FDA) oversees the safety of food, drugs and cosmetics in the United States.
However, the FDA was not the first law to address regulation of food and drug products; that task started with the ‘1906 Pure Food and Drugs Act’. This act later gave way to the ‘1938 Food, Drug and Cosmetic Act’ (FDCA).
When the FDA was born in 1930, FDCA ceded the task of administering food, drugs and cosmetics safety to the FDA.
In 1976, Wisconsin Democrat Senator William Proxmire sponsored the ‘Vitamins and Minerals Amendment’, which limited the powers of the FDA to regulate mineral and vitamin amounts in nutritional products. This amendment was then upturned by the ‘Nutrition Labeling and Education Act of 1990’ (NLEA) and the ‘Dietary Supplement Act of 1992’, which enabled the FDA to influence nutrient potency claims in food supplements.
Enter the ‘Dietary Supplement Health and Education Act of 1994‘, which is still current and which seeks to protect consumers from the dietary claims of supplement manufacturers. This Act provides that consumers have the right to know all dietary information contained in any food supplements before they purchase it, hence the comprehensive and accurate labeling that we see on labels today.
Adverse Reaction Claims That Gave the FDA the Current Impetus to Oversee the Industry
Several negative events compelled the government to increase its regulatory role in overseeing the manufacture, distribution and consumption of dietary supplements. A few of the worst incidents involved thousands of hospitalizations and hundreds of deaths, as well as several thousands complaints resulting from adverse reactions attributed to nutritional supplements.
The FDA dug into these incidents and found that several dietary supplements do not meet the agency’s standards for safety and effectiveness. To break these down, the FDA found in recent years that several food supplements:
- Were fraudulently labeled
- Did not contain active ingredients listed on their labels
- Did contain dangerous levels of harmful compounds
- Did contain exaggerated or unsubstantiated benefit claims
- Were pure scams
These events affected many consumers’ lives, causing the government to increase its surveillance and regulatory roles in the dietary supplements industry.