Immediate GMP Compliance for Dietary Supplements - What's the price of Compliance?

The FDA calculated the price tag of Good Manufacturing Practices (GMP) whenever they first drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary supplement GMP regulations, located in the Federal Register, lanta flat belly shake australia encompass everything estimated costs, concerning compliance, that a company will incur depending on small business size. The FDA estimated that altogether dietary supplement manufacturers will invest 56,000 hours as a one-time burden in development of written methods. Furthermore, 930,000 hours was estimated as the sum total for all businesses to carry out sufficient record keeping. The FDA then used this data to estimate the economic impact for various sized companies.

Cost per Establishment by Size

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

Little Establishments

Set up Costs = $26,000

Annual Costs = $46,000

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

Medium Establishments

Set up Costs = $20,000

Annual Costs = $184,000