The FDA calculated the cost of Good Manufacturing Practices (GMP) whenever they 1st drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary supplement GMP regulations, located in the Federal Register, keto diet pill; visit the up coming document, encompass all estimated costs, associated with compliance, that a business would incur depending on small business size. The FDA estimated that altogether dietary supplement companies would spend 56,000 hours as a one-time burden of creation of written procedures. Furthermore, 930,000 hours was estimated as the sum total for those businesses to conduct adequate record keeping. The FDA then used this data to calculate the economic impact for different sized companies.

Cost per Establishment by Size

Little Establishments (Less than 20 employees with annual revenue under $1M)

Little Establishments

Set up Costs = $26,000

Yearly Costs = $46,000

Moderate Establishments (twenty — 500 staff with annual earnings of $5M — $10M)

Medium Establishments

Set up Costs = $20,000

Annual Costs = $184,000