Is it Amazon’s job to fix a problem that was decades in the making?

The former represents the upright, transparent side of the industry. These are companies that are proud to talk about their sourcing relationships, the testing they do on incoming raw material, and other hallmarks of quality. They’re forthright about disclosing contract manufacturing arrangements, if they have them.  And they’re the sort of companies that attend regulatory sessions at trade shows, participate in and help fund industry initiatives and so forth. 

The dark side

Then there’s the other side of the industry. Many of my sources will often remark that when they read FDA warning letters they rarely if ever recognize the names of the firms being taken to task. It’s a big enough industry that it’s hard to know everyone, of course.  But this penumbra of the business is populated with players who it seems would rather not be known, so it’s hard to put a number on how much of the overall industry these kind of companies represent. Five percent? Ten? More?

Other industries have similar issues. I live in Colorado where roof-shredding hailstorms are commonplace.  Commonplace, too, are the fleets of phony roofing trucks​ that troll neighborhoods in the wake of such an event. Get yourself a used truck, slap on a vinyl sign and—presto!—you’re a roofer.  

Low barrier to entry

It’s almost as easy to become a dietary supplement brand holder.  If I had $50,000 laying around to play with, I could pick up the phone and have some sort of product for sale somewhere in just a few weeks.  Many brand holders in that scenario rely more or less completely on their contract manufacturers for GMP compliance, CofA verification, etc.   Assuming they even know what the letters “GMP” stand for, that is (some don’t, and I’ve witnessed this in person).  Approaching the creation of a new product in that way gets this relationship exactly backward according regulators. FDA is adamant that the ultimate responsibility rests with the brand holder, which I’m sure has come as a nasty surprise to some of these neophyte firms.

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