This post about Dietary Supplement Regulation was written by Robert Pochadt, Director of Sales for InstantGMP
From inside and outside the industry, uncertainty abounds; here’s what that logo on the package really means.
- GMP FDA Certification
- GMP Registration
- GMP Compliance
Only two of these items actually exist. In the hyper stimulated media place we inhabit two are no-brainers. In the more obscure world of GMP matters for dietary supplements, a growing, increasingly important, often misunderstood industry, the understanding is less clear, but the confusion is real.
Why important anyway?
It’s important for the consumer to ensure an understanding of that ‘stuff’ you bought for your health, at least the safety factor (87% of US citizens take at least one type from this $30 Billion industry), and how it is controlled. And it’s important for the producer to deliver it right for you. Healthy must prove safe.
Yes, there are certified horror stories including fatalities from adulteration, or just plain wrong or bad ingredients, found in these products. And it’s true that meaningful ingredient information is sometimes hard to come by, given that certain vendors are long on hurling stunning images at you in a most in-your-face manner (it sells, right?) and short on meaningful product information.
And despite the fact that the industry is mandated to comply with guidelines issued by FDA, there are still those who are in it primarily for a quick, dirty buck (or Rupee, or Yuan) and are more skilled in the art of evasion than delivering trusted product quality. Caveat emptor, semper.
Let’s take a closer look at the regulatory process to begin our “learn more”:
The best place to start is to know upfront what isn’t; and that, simply put, is GMP FDA Certification. FDA, which created GMP guidelines, does not itself certify a product or producer for GMP compliance.
The certifications and registrations (used somewhat interchangeably for client companies; also, their products can be certified and logoed for proper content as well) that are offered for GMP guidelines are all third party offerings. Two groups, NSF and NPA, have taken a leadership role in this area, have considerable subject matter depth, and provide programs which are essentially audits augmented by education and training.
FDA does not anoint any third party provider or program with its preference, or even give them its recognition; however these two organizations do offer best industry practices, and provide a solid experience base to help with the process of becoming GMP compliant, the real goal.
Displaying the third party registered/certified logo on a supplier website or a product will demonstrate company diligence in one of these programs. The certifications and registrations are good for a finite time span (6 months to 2 years) and must be renewed at the end of the interval to be sustained.
So what is this ‘GMP compliance’? It’s essentially ‘walking the GMP walk’, that is, understanding the GMP guidelines and demonstrably following them with the required processes, procedures, and documentation firmly in place. The FDA audit is the real test, the only way you can be sure you know where you stand. But since the warning letters issued by FDA are public record, it’s not a wise business strategy to wait until they come to develop a punch list for your firm. You must respond to everything cited with a plan within 2 weeks, meanwhile your competitors might pounce and your customers might panic and vanish. Better to do a preliminary “dry run” with assistance from these third party groups as needed for a gap analysis exercise.
Here’s a key point: GMP third party certification and registration does not ensure GMP compliance. There have been GMP violations at companies that have duly completed the registration or certification process mentioned above. Most of those involve mandated documentation that was not in place. GMP compliance requires continuous, rigorous attention and action, an eye always on the GMP ball. It should remain a goal. It’s an ongoing cost of doing regulated business.
I want to mention one other point on the subject that really grinds the gears of FDA enforcement; the publicized statements that show up occasionally on dietary supplement vendors’ websites announcing that they successfully passed an FDA audit. FDA sees that as bare competence, not excellence. So should you.
It’s like a grocery store displaying a sign that all their food is edible.
As the market for dietary supplements continues to expand, these considerations take on extra meaning as the dynamics of the supply and commerce chain continue to evolve. For best or worst, It’s a world market, and until we can make certain everybody plays by the same good rules, the standards will remain dubious for a portion of it.
Knowing the inner workings of the regulatory authorities, at least from a fundamental level, can only contribute to the peace of mind that comes with well informed choices and actions by both consumers and producers.