Update from SupplySide West

After three days of SupplySide West education sessions on pertinent regulatory, marketing and scientific topics, a few tidbits have stood out. It is no surprise the industry is worried about new dietary ingredient (NDI) regulation. However, many education program speakers have passed on word from FDA that while the industry is concerned about NDIs, they should be worried about GMPs (good manufacturing practices). Speaker Joy Joseph, former Pharmavite QC leader and founder of Joy's Quality Systems, flat out told her seminar audience, You are failing [GMPs].

FDAs Brad Williams once again participated in the education program, and he said the number one issue with companies inspected under the supplement GMP program has been failure to adequately test ingredients for identity. FDA has ramped up the number of GMP inspections over the past year or more, and has concurrently increased its enforcement actions in this area. While, as Williams noted, it is almost guaranteed an inspected company will get a 483 reportthe document from the inspector, detailing even the minor issues the company needs to addresshow companies respond to the 483 report is crucial. Given the 15-day window to reply to a 483, companies need to take action very quickly. Longtime attorney Anthony Young even suggested a company should fix the smallest and easiest to correct violations before the inspector has left the facility. Otherwise, the key to adequate response within 15 days is detailing how your company has already established a corrective action, be that a specification, procedure, testing protocol or other requirement. Numerous speakers advised telling FDA your company will fix the problem or establish the spec/procedure/etc. by a designated future date is likely to be considered inadequate by FDA and prompt further enforcement steps.  

These next steps have occurred too frequently in the past year or so, mainly in the form of warning letters issued to companies who have not responded adequately on a range of issues such as ID testing, plant and ground maintenance and cleanliness, and failure to establish and follow specifications, master manufacturing records and batch records. Most industry regulatory experts speaking at SSW said they expect this level of enforcement and scrutiny to continue, and Williams punctuated this prediction, saying, I think people realize based on the past year and a half, we are not shy about issuing regulatory action.

When the question of whether the GMP struggles and intensified regulatory actions will bring unwanted criticism on the industry and DSHEA, Young replied, This is DSHEA. He noted GMPs are a huge part of DSHEA that industry asked for to show it is a high-quality, aptly regulated industry. Clearly it is time to comply or find another industry for your companys operations.

One other interesting development on GMPs is in the area of contract manufacturing and own-label companies. In a few sessions, namely the contract manufacturing presentation by industry attorney Marc Ullman, partner at Ullman, Shapiro & Ullman, and Mark LeDoux, CEO of Natural Alternatives International (NAI), it was noted FDA has publicly (via warning letters) indicated it will hold own-label companies responsible for the products that bear the companys name and label but which were made by a contract manufacturer. This came as a surprise to many insiders, but it is a development industry should heed in its efforts to comply with GMPs.

Expect more coverage from INSIDER on these issues going forward.