Thursday, July 25, 2013

FDA Targeting Vitamin Companies

The Regulatory Compliance Network Responds 

FDA News, an industry information source, put it succinctly a couple weeks ago:

"FDA on the hunt..."
Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus...”
When health freedom advocates convinced Congress to unanimously adopt the Dietary Supplement Health and Education Act of 1994 (DSHEA) it was no easy task. I remember those days, before the internet, well. We rallied at FDA locations around the country; we lobbied Congress the old-fashioned way, with phone calls, letters, petitions and faxes. I remember bringing my then 5 year-old son to DC for the march on the Capitol that lead to adopting DSHEA, the law that allowed us, for the first time, speak truthfully about the nutrient benefits of dietary supplements. It was a breakthrough and the bureaucracy has been trying to take back those concessions to our freedom of inquiry and speech ever since! We didn’t give up in ’94 and we will not let the stimulus-money, beefed-up FDA regulate our industry out of existence. The Regulatory Compliance Network, a collaboration of industry professionals, is ready to react proactively:

We knew at the time, in ’94, that the bill was a compromise between our right to seek natural means for health and the power of the Big Pharma lobby, aided and abetted by their cronies in the federal agencies. But Congress not only acknowledged our right to communicate about, and market dietary supplements, it also told the FDA that any regulations about good manufacturing procedures must be modeled after food regulations, not drug regulations. That difference is significant. Dietary supplements are foods, not drugs. Foods support normal structure and function. Drugs change the body to suppress symptoms of disease.

Fast-forward about a decade. FDA finally got around to implementing the regulatory authority granted by the dietary supplement law. Two primary sets of regulations, with associated guidelines, were proposed, adopted and phased in, over the several years. These were the “Structure and Function” regulation that tells companies what types of “support” claims can be made for dietary ingredients and the cGMPs – the Current Good Manufacturing Practices regulation. Today, with those regulations in place, and with thousands of new compliance offices hired with Federal stimulus funds, the FDA is, as our industry source says, “On the hunt…”

The Natural Products Association opined,
"FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “'the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.'..."
One FDA Compliance Officer told me:
Your company, as label-owner, must be in a state of control with its training, labels, claims, manufacturer, shipping & customer service…”
In the past I would tell my dietary supplement clients that they might be inspected by the FDA once in a decade, or not at all. Today, every company that owns its own labeled products can expect yearly or almost yearly inspections. The supplement industry is being held to strict standards and those companies that are well-organized businesses will have a competitive advantage.

To make the best of that advantage, or even to effectively communicate to the customers, “your papers must be in order…” Gone are the days when “mom and pop” vitamin companies could bottle their own products and just start marketing. Today, companies need to have a sophisticated approach to doing business. 

Standard Operating Procedures are intended to ensure that the public is offered products that are consistent as to “purity, identity, composition and strength…

But it is not enough to have written procedures, according to FDA (Federal Register, pages 34811):
"...each person engaged in an activity covered by these cGMP regulations must have the education, training, or experience to perform the person's assigned functions. Some employees will be considered qualified based in part on training taken as company employees. To show that such training is appropriate to the employee's functions and has in fact occurred, the training must be properly documented. 
This documentation is an important aspect of ensuring adequate training and, therefore, helping to ensure the result of having qualified employees who perform their functions properly.

The FDA introduced the cGMPs by reminding us all:
"The dietary supplement market has changed significantly since the passage of DSHEA. The industry itself has grown exponentially and so has the number of Americans buying these products. Access to dietary supplements has also changed. Today a wide range of dietary supplements can be purchased in supermarkets or through the Internet...”

Conducting the Certification Training at
Global Healing Center, Houston, Texas

The Federal authorities understand that Americans want their supplements. 

The strong public support that caused Congress to do that which it hardly ever does, adopt a controversial law unanimously, with no dissent, proves that. Nonetheless, the natural tendency of bureaucracy is to expand into every nook and cranny of voluntary human action. The unregulated is seen as a threat. Marketers, on the other hand, see the unregulated as an opportunity to meet consumer demands expeditiously. The tension between American industry and bureaucracy has grown for generations.

The regulatory pendulum swings this way and that way. Today, with a Federal bureaucracy emboldened by gridlock in Congress, and with ever more taxpayer or borrowed money to spend for enforcing regulations, those regulations are being interpreted in the most onerous manner, leaving little room for small companies to continue their critically important roles as innovators.

What is to be done? An aware public needs to keep the pressure on the Congress so the bureaucracy is not able to ratchet-up controls without limit. As one of the trustees of Natural Solutions Foundation – Health Freedom – I am very aware of the strong support that our dietary supplement market has from the public. You can help educate decision-makers here:

Dietary supplement company management will do what management must always do: manage. That means complying with the cGMPs to assure the public that Americans can still buy the best, highest quality and potency nutrients available anywhere on earth. To do that, the companies need to get much more serious about how they organize the ways and means they have to satisfy the consumer. My experience is that very few dietary supplement companies are in full compliance with all requirements.

The Natural Products Association sees the same issue:
"Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study … by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers.  A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.'..."
The science behind the benefits of dietary nutrients continues to advance. 

The problem the market faces is how to substantiate the claims that can be made about those nutrients. WHO, the World Health Organization, told us in 2002 that the chronic diseases of modern life – cancer, heart disease, diabetes, obesity, are all the “noncommunicable diseases of mal- and under-nutrition.” It is the role of the dietary supplement companies, whether large or small, new or well-established, to educate the public about the tremendous health benefits of good nutrition.

To do that, the companies need to stay in business by effectively meeting the increasing regulatory standards.

Education is the key. 

The companies are now required to adopt written Standard Operating Procedures and engage in third-party training and certification, to meet the higher standards expected from companies that are providing essential nutrition for our health and well-being.

That’s why I’m working with some of the leading educators in the natural products field, to form the Regulatory Compliance Network. Learn more here:

Dr. Group about the SOP / cGMP Certification Training Program