Issue link: https://www.e-digitaleditions.com/i/292644
A 32B April 2014 Tablets & Capsules regulatory compliance Top 10 ways to get an FDA warning letter (and how to avoid them) Lisa Thomas NSF International Of all the FDA-regulated industries, dietary supplement man- ufacturers are most likely to fail quality inspections and receive warning letters from the Agency. This article examines why and tells you how to meet regulatory standards. s of June 2010, the third and final subgroup—i.e., companies with fewer than 20 full-time employees—was required to comply with current Good Manufacturing Practices (cGMP) for Dietary Supplements (21 CFR Part 111). Since the new regulations went into effect, the number of warning letters issued by the US Food and Drug Administration (FDA) has increased every year. According to data obtained through a Freedom of Information Act request, about 70 percent of the dietary- supplement manufacturers inspected by the FDA fail to meet one or more GMP standards [1]. The root of the problem There's no reason that regulatory compliance should be any more difficult in the dietary-supplement industry than in other FDA-regulated industries, such as pharma- ceuticals, food, and medical devices. So why is compli- ance so poor? A few possibilities: g1-NUTRA_32A-32L_Nutra 4/3/14 2:42 PM Page 32B