Instant GMP Compliance for Dietary Supplements — What’s the cost of Compliance?

The FDA calculated the cost of Good Manufacturing Practices (GMP) whenever they 1st drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary product GMP regulations, located in the ice hack for weight loss (https://urbanmatter.com) Federal Register, encompass everything estimated costs, concerning compliance, that a company would incur depending on small business size. The FDA estimated that altogether nutritional supplement makers would invest 56,000 hours as a one-time burden in creation of written methods. Additionally, 930,000 hours was estimated as the sum total for all business enterprises to carry out proper record keeping. The FDA then used this data to estimate the economic impact for different sized companies.

Cost per Establishment by Size

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

Small Establishments

Set up Costs = $26,000

Yearly Costs = $46,000

Medium Establishments (twenty — 500 workers with annual revenue of $5M — $10M)

Moderate Establishments

Set up Costs = $20,000

Yearly Costs = $184,000