The FDA calculated the cost of Good Manufacturing Practices (GMP) whenever they first drafted the Dietary Supplement Health and exipure diet Education Act (DSHEA). Dietary supplement GMP regulations, located in the Federal Register, cover everything estimated costs, concerning compliance, that a business would incur based on small business size. The FDA estimated that altogether nutritional supplement makers would invest 56,000 hours as an one time burden of creation of written methods. Additionally, 930,000 hours was estimated as the sum total for all business enterprises to carry out adequate record keeping. The FDA then used this data to calculate the economic impact for different sized companies.

Cost per Establishment by Size

Small Establishments (Less than 20 employees with annual revenue below $1M)

Small Establishments

Set up Costs = $26,000

Annual Costs = $46,000

Medium Establishments (twenty - 500 employees with annual earnings of $5M - $10M)

Moderate Establishments

Set up Costs = $20,000

Yearly Costs = $184,000