Dietary Supplement Handbook: Part 8 - Industry Regulation (DSHEA 1994)

DSHEA (1994) is important legislation, passed by the US Congress, to amend the Federal Food, Drug, and Cosmetic Act (1938); further defining supplement industry standards, regulation, and safe manufacture. In 2000, further rulings, for supplements by the Food and Drug Administration (FDA) regulate them solely as food and not drugs for medical use.

Supplements are a Type of Food

DSHEA (1994) creates additional supplement regulation by defining supplements as a type of food that are reportedly used by 57% US adults for supporting, maintaining, and promoting health, wellness, and well-being.

Types of Supplements

Dietary supplements are defined any combination of the following dietary substances:

• Vitamins
• Minerals
• Herbs
• Botanicals
• Amino Acids
• Concentrates, Metabolites, or Extracts from foods.

Supplements are Added to the Diet

The DSHEA (1994) states that supplements are foods added to the diet and taken with meals.

Supplements exclude intoxicants, recreational drugs, and pharmaceutical drugs.

Supplements Use Generalized Educational Health

Supplement regulation promotes and sells supplements by educating the buyer in how they support health and well-being through documented scientific research and study. Supplements have a generalized non-medical, non-disease, and non-health-condition benefit in supporting health. Current scientific ways for understanding and selling dietary supplements include:

General health and wellness: A supplement with generalized non-medical health and wellness benefits, which is shown by historical use (e.g. tradition and herbalism) and/or with reliable scientific research and biology study (e.g. biochemistry, nutrient science, and herbal medicine). 

Examples: Ginger concentrate has traditionally been used medicinally for promoting digestion; Skullcap has been used in herbalism and studied in herbal medicine as a calming and relaxing medicinal remedy.

Nutrient content: Show specific nutrients are present within a supplement (e.g. vitamins, minerals, & amino acids). Books and scientific literature provide reliable and valid information and scientific analysis for the nutrient content of supplements. 

Examples: Goji berry extracts contain beta-carotene which is good for the eyes; Amla berry contains vitamin c which is good for the immune system.

Structure/Function: Scientific literature shows how any nutrient or constituent of a supplement works within the metabolic activity and processes of a structure and/or function of the body. In other words, a supplement has structure and/or function benefits when it is scientifically shown to be concentrated and/or metabolized within a system, organ, gland, fluid, and/or tissue. 

Examples: Calcium is concentrated in bones and promotes bone health; Omega-3 fatty acids are metabolized within the heart and maintain heart health; Salt (both sodium and chloride) is used by the cells within the stomach to promote stomach acid for digestion.

Importantly, medical studies may be used because they use the scientific method of hypothetical deduction, including animal or human studies, observational studies, and/or clinical trials. Find information about the structure and/or function benefits of supplements when using a medical study instead of using it to try and confirm through inductive inference a specific outcome of a drug-like mechanism of intervention in disease and health-condition causes; thereby excluding the irrelevant disease or unrelated health-condition claims and conclusions.

Manufactures Use Health Education in Supplement Promotion

The DSHEA (1994) prevents individual manufactures from making specific exclusive claims about the effectiveness of their own branded supplements. Instead manufactures use general health education (i.e., traditional uses, health education, & scientific methods) of the health benefits of the types of supplements that they manufacture.

The Food and Drug Administration (FDA) Regulation Limitations for Disease Related Health Claims

Note that final rulings in 2000 from the FDA have greatly limited the scope of the US Congress' passage of DSHEA (1994) and vastly reduced the FDA's own ability to approve and promote foods and supplements with intended medical use in the treatment, prevention, and management of diseases and health-conditions; by disallowing all unapproved disease and health-condition claims for foods and supplements. Approved disease and health-condition claims are sometimes confusingly known as health claims within agency documentation.

Non-Deceptive Supplement Promotion

The DSHEA (1994) requires any published health supporting and promoting information used with dietary supplements be presented as truthful, and not misleading, according to accepted non-medical understanding, including traditional uses, health education, and scientific methods of research.

Under FDA agency ruling in January (2000), regulation was established that all information for dietary supplements cannot suggest disease and health-conditions related prevention, treatment, and management effects, unless they are agency approved as a qualified health claim.

 

The Federal Trade Commission (FTC) works with the FDA to offer guidance in avoidance of deceptive advertising for supplements.

DSHEA (1994) for Safe Manufacture of Supplements

The DSHEA (1994) authorizes US government and the FDA agency regulatory oversight to set the requirements for safe supplement manufacture, which is known as Current Good Manufacturing Practice (CGMP); based on food processing and procedures, including sanitation, packaging, and labeling.

DSHEA (1994) for a Thriving Supplement Industry

Ultimately, the DSHEA (1994) is regulation passed by the US Congress to encourage the supplement industry to promote health education with the sale of dietary supplements without medical quackery and without interference or corruption from the pharmaceutical industry. 

Combined, the DSHEA (1994) legislation and FDA rulings regulate the FDA by prohibiting the FDA from approving foods and supplements as drugs, while also prohibiting anyone from promoting, selling, and using foods and supplements wrongly as drugs and medical treatments for the prevention, management, and cure of diseases and health-conditions.