Dietary supplements are products designed to supplement your diet with additional vitamins, minerals, herbs or other substances – and are not subject to FDA oversight in the same way that medicines are.
Be wary of supplements with exaggerated claims. Avoid products which claim to cure diseases, boost energy or burn fat.
They are not regulated by the FDA
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements are considered food rather than medicine, so they can be sold without proof of effectiveness or safety. Instead, manufacturers are responsible for overseeing this aspect and making sure labels list accurate ingredient listings.
DSHEA also permits supplements to make claims that “maintain and promote normal structure and function” within the body, while mandating that manufacturers submit New Drug Information Nos (NDINs) before selling their product to FDA.
Consumers face risks from this legal loophole if the manufacturer makes false or misleading claims about the product, leading to risks in terms of health or financial implications. To mitigate such risks, doctors must engage their patients in discussions regarding supplement use; encouraging them to seek information from reliable sources like National Institutes of Health as well as acknowledge that supplements cannot replace a balanced diet.
They are not regulated by the Food and Drug Administration
Dietary supplements in the United States do not need premarket approval by the FDA; however, according to the 1994 Dietary Supplement Health and Education Act manufacturers must provide evidence that their products are safe before selling them to customers. By contrast, drugs must go through rigorous testing before being approved for sale on the market.
Many people take dietary supplements because they believe the nutrients found within them are necessary to maintaining good health. Some may require supplements during specific times in life – like pregnancy when folic acid can prevent birth defects – while others may lack essential vitamins and minerals due to deficiency, or have trouble digesting food that contains these essential components.
Unfortunately, the FDA’s limited ability to protect consumers from unsafe supplements can be traced back to an outdated law which permits companies to make unsubstantiated claims about their products. Other high-income countries possess more extensive regulatory systems for dietary supplements; Australia requires companies selling supplements to submit details on all ingredients prior to selling.
They are not regulated by the Department of Agriculture
The Food and Drug Administration has divided substances it regulates as food into several categories, such as foods, food additives and added substances (man-made substances not intended to enter food but nevertheless end up there). Each category is subject to different standards set by the FDA; accordingly legislation has granted this agency various tools with which it may address violations of these standards.
Dietary Supplement Health and Education Act (DSHEA) defines dietary supplements as any product containing “dietary ingredients” with the intent to enhance diet. This can include vitamins, minerals, botanicals, amino acids and any concentrations or combinations thereof that aim to provide additional nutritive value in our daily lives.
Although DSHEA requires manufacturers to guarantee the quality, safety, and effectiveness of their products, regulations for over-the-counter drugs and pharmaceuticals are more stringent in this respect. For example, while Good Manufacturing Practice rules (cGMP) mandate quality control testing during manufacturing processes; with regard to dietary supplements this does not occur as regularly; Sarma Giancaspro Venema (2016) reported on an issue where raw ingredients that may already contain contamination could still be used as raw ingredients by manufacturers.
They are not regulated by the Department of Health and Human Services
Dietary supplements are products consumed to add extra nutrients to our daily diets. Dietary supplements come in many forms – pills, tablets, capsules, gel caps, gummies, softgels powders and liquids can all provide extra vitamins or minerals. Dietary supplements may contain vitamins or minerals; herbs or botanicals; amino acids or live microbials; concentrates, metabolites constituents or extracts thereof – as well as concentrates, metabolites constituents or extracts thereof. Dietary supplements may help people who require high amounts of certain nutrients such as iron and Vitamin D during pregnancy or people suffering malabsorption disorders.
The FDA regulates supplement products through DSHEA, which limits their ability to oversee them and has led to widespread contamination with toxic and heavy metal contaminants, and wide variations between what was promised on label and actual contents of product. As a response to these problems, they have requested mandatory product listing with clear recall authority in order to address this situation.
