What if FDA Gets Cut?

Like every organization, public or private, the Food & Drug Administration has a budget.  That budget changes from year to year depending on Congress and the Executive Branch.  If that budget gets cut, what does it mean for ordinary citizens?

Let’s first look at the big picture and then drill down.  Here’s a list of the types of products FDA regulates:

• Food, human & animal
• Drugs, prescription & OTC
• Infant formula
• Medical Devices
• Dietary Supplements
• Radiation-Emitting Products
• Tobacco Products
• Cosmetics
• Vaccines, Blood, and Biologics

Quite a list, right?  Near $ 3 Trillion per year of products that FDA is responsible for ensuring safety and effectiveness. 

Now let’s narrow to a common and popular segment that people buy at stores and through the internet, Dietary Supplements.  It’s a big, and growing market:

• > 50% of Americans take dietary supplements

• US Market ~ $40B

• > 3% growth rate in constant $s

FDA does regulate dietary supplements.  Surprised?  Well, they do, but in a more limited way than drugs.  FDA regulates the manufacturing of dietary supplements.  But their ability to regulate the health claims made for dietary supplements is restricted by Congress to almost nothing.

So, if you are wondering whether dietary supplements actually work as advertised, you’re on your own.  Look here to get started.

Nevertheless, FDA has saved many lives by the inspections that they make of dietary supplement facilities.  FDA inspects about 500 plants per year for sanitary conditions, testing, and procedures.  That sounds like a lot, doesn’t it; until you recognize how many dietary supplement plants there are.

Those 500 inspections only amount to 5% of known facilities.  Let’s state that another way.  Each facility can expect to be inspected once every 20 years.  Ask yourself this question, “If I’m the owner of a dietary supplement company, how worried should I be about the next inspection?”

The answer, if you’re a typical owner, is not much.  That’s not to say that owners are bad people.  My experience is that the vast majority want to make good products.  The problem is that it only takes a few bad actors to lower the standards for everyone.  And there are definitely some bad actors in this business. 

According to The New England Journal of Medicine, “we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements.”

However, the fact is that even the 500 inspections / yr that FDA makes has saved many lives. 

Now let’s go back to budgets.  FDA’s budget for regulating dietary supplements is about $11 million annually, a tiny fraction of the $40 billion industry it oversees.  What would happen if FDA’s budget gets cut?  That would mean that the 20 year interval between inspections would get even longer.  Essentially removing the threat of an inspection entirely from the tenure of the average owner.  Any cut to FDA’s budget would result in serious increases in the rate of adverse reactions to dietary supplements.

How about you?  What’s your experience?  Comment below.