How Supplements Are Regulated: DSHEA 1994 vs FDA Drug Approval

The Statutory Framework: DSHEA 1994 Defined

In 1994, the US Congress enacted the Dietary Supplement Health and Education Act (DSHEA), establishing that dietary supplements are regulated under the food safety framework rather than the pre-market pharmaceutical new drug approval (NDA) process.

What 'FDA Registered Facility' Actually Means

While supplements themselves are not 'FDA approved', the facilities that manufacture them must be registered with the FDA and adhere to 21 CFR Part 111 current Good Manufacturing Practice (cGMP) regulations, governing sanitation, identity verification, and heavy metal testing.

Structure/Function Claims vs Disease Claims

Federal law permits supplements to state how ingredients support normal biological structures (e.g., 'supports working memory and cerebral blood flow'). They cannot legally claim to treat or cure clinical diseases (e.g., 'cures dementia or Alzheimer's').

Consumer Protection and Mandatory Disclaimers

The mandatory FDA disclaimer displayed across ecognizil.com is a legal hallmark of compliant, ethical US supplement distribution, assuring buyers of legitimate regulatory adherence.