For too long, a light touch from FDA has allowed critics of the industry to claim dietary supplements are not regulated, and that the industry is like the Wild West.
The industry is regulated – it has its very own regulation (DSHEA) – and FDA deserves credit now for flexing its muscles. Most of the serious suppliers, companies and associations I have talked to are happy to see it.
We shouldn’t be surprised by this: FDA Commissioner Margaret Hamburg, MD, sent a letter to supplement manufacturers in December reminding them of their legal obligations and the need to remain vigilant to protect their industry.
This was followed by a warning to consumers in March to “beware of fraudulent dietary supplements”.
Case study
At the start of the month, the Department of Justice found two New Jersey based supplement companies and their owner guilty of multiple counts of criminal contempt of court for violating a consent decree.
The announcement was greeted by applause from a raft of trade associations, including the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).
As CRN president Steve Mister told me in an interview last week, the recent events are reminding the industry that FDA has teeth.
Not everybody was happy though. We received one comment from a reader who criticized FDA:
“OK, we've got live rats running through the plant and dead rats too! But was anybody harmed? Did patients die or suffer health effects? Sanctioning a company is one thing, putting them out of business is another. Why would the industry applaud this? It's an FDA overkill (not the rats, the company),” read the feedback.
Really? So companies that flout basic sanitary guidelines should be allowed to continue to operate, albeit with sanctions, despite warnings from the authorities?
Nobody was harmed? “Yet!” I would like to add. With rodent feces and missing rodent parts floating around a facility, you could argue it was only a matter of time.
FDA was within its rights to do what it did, and I echo the applause from industry.
Claims
I also applaud the recent activity regarding claims being made on products: If you make disease claims, you’re a drug and you need to go through the channels for that. If you want to be a dietary supplement, then follow the rules laid out in the Federal Food, Drug, and Cosmetic Act.
Warning letters are issued for a reason – to warn – and nobody should act surprised or upset when tougher action follows.
Pats on the back
For the moment, many are happy to see the regulators regulate. Some are, as the feedback suggests, conscious of potential over-enforcement by the authorities. Let’s also not forget that action after action by FDA or FTC may also be interpreted by some that the industry is full of offenders, but responsible and serious players have nothing to fear from such enforcement.
Industry associations are also playing their part: Look to the Natural Products Foundation’s recent referral of 13 dietary supplement firms making unauthorized disease and drug claims about dietary supplements to FDA and FTC, and CRN’s funding of an attorney specifically to tackle false claims about dietary supplements at the National Advertising Division of the Council of Better Business Bureaus (NAD).
Showing how it’s done
It is also pleasing to see responsible companies reacting quickly to potential issues. Only this week, NOW Foods swiftly issued a voluntary recall when two supplement batches were found to contain way more vitamin D then they were supposed to.
After receiving only a couple of adverse event reports (AERs) related to the products, the company initiated in-house lab tests and quickly issued the recall. Credit to NOW Foods for its professional, responsible and swift handling of the situation.
Take home
After a busy few months, there appears to be no sign in the downturn of FDA/FTC activity. If everyone wants to play the game professionally, then they have to accept the decisions of the referees: The ref is there to ensure everyone plays by the same rules, and we should respect that.
Hopefully, recent activity is merely the storm before the calm.