Supplement Safety & Regulation

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Dietary Supplement Health & Education Act of 1994 (DSHEA)

Contrary to some of the information you’ll find, the dietary supplement industry is well regulated thanks to the passage of the Dietary Supplement Health & Education Act, or DSHEA as it’s commonly referred to.

DSHEA is the federal statute passed in 1994 that defines what dietary supplements are and how they should be sold and regulated.

Under DSHEA, a dietary supplement is defined as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any ingredient noted in clause A, B, C, D or E.”

Some of the findings from Congress that made this law possible include (keep in mind these findings are from 1994):

  • The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies
  • Promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditure
  • There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health
  • 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

Source: National Institutes of Health Office of Dietary Supplements webpage

Like foods, drugs, and other commercial goods intended for human consumption, dietary supplements are regulated by the federal government. Since 1994 this regulatory framework has kept Americans safe and ensured that responsible manufacturers have safety and quality benchmarks to adhere to, leading to standardization and reproducibility in manufacturing.

In the event of an issue with a dietary supplement, there is a robust reporting system in place called Adverse Event Reporting (AER) that allows consumers, health care providers and others to quickly report a complaint, concern or problem related to dietary supplements to the FDA.

In addition, responsible manufacturers have the ability to initiate a voluntary recall if they feel there may be an issue with a product they produce after it’s been released into the marketplace.

Between NOW’s robust manufacturing and testing processes, and federal regulations for the manufacture of dietary supplements, you can rest easy knowing that NOW® supplements are safe for their intended use when taken as directed.