Product quality: the never-ending frontier of GMP

Following up on a post from June 30, the question of consumer confidence in nutritional supplements arises again. The Times-Herald reports that many supplements have quality problems.  No one knows just how many of 40,000 products underdeliver on the goods listed their labels and over-deliver on unlisted, harmful ingredients and contaminants. “I believe that the problem is narrow, that the well-established and reputable brands deserve their reputations,” Michael McGuffin, president of the American Herbal Products Association, tells the paper that serves the Hudson Valley of New York.

The article then reels off test results that indicate a much broader problem:  “In ConsumerLab.com tests, six out of nine chondroitin supplements failed testing in April 2007. One had only 8 percent of what it claimed to contain, and one ‘maximum strength’ product had none.”

How big will the elephant become before the people in the room acknowledge its presence? And who will act first: manufacturers, regulators, consumers, Congress, a state attorney general, or a sharp civil attorney? And which company will be hounded out of existence as an example to others in the industry?

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

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2 Comments

  1. Bill Mead said:

    I agree that there have been quality problems, but in my opinion, the new dietary GMPs now in force will do much to eliminate this. However, this will not happen overnight but instead will follow a learning curve. FDA will be doing many facility inspections, and where quality systems are deficient, will issue 483s, and in some instances also Warning Letters, which will result in needed corrective action.

    Most of the larger firms in this industry are, and have been, in essentially full compliance, since most have well-trained and experienced staffs who do fully understand what’s needed and have implemented the requirements. It is in general the smaller firms that will need time to catch up. There are also a few unscrupulous firms, and some importers, trying to “rip off” consumers, but FDA’s Office of Criminal Investigations is active in stopping such activities.

    While the dietary supplement GMPs are not perfect, they can be looked upon as a work in process and will undoubetdly be further improved and explained as both the agency and the industry gain experience with them. They are definitely a major step in the right direction.

    I’m a retired chemical engineer from the OTC drug manufacturing industry, and I’ve been involved with GMP compliance matters since their inception in 1962. I was on the industry team that wrote the first draft of the dietary supplement GMPs. I’m currently writing a book, to explain in common language just what these complex dietary supplement GMP regulations mean, and suggesting some approaches to compliance, based on my experience. This is my “swan song,” and is an effort to help both the industry and the consuming public. Hopefully this book will be helpful, particularly to the smaller firms that may lack experience in this arena.

  2. Tyer Stokes - Health Supplement Choices said:

    It seems that the only people trying to help the consumer with quality issues regarding supplements are bloggers and website owners who bring up these concerns.

    Many more people on the Internet are discussing these issues and that’s a good step forward. Any chance I get I try and tell people that quality really matters when it comes to nutritional supplements I do.

    Selling yourself to the lowest bidder is not a good way to get healthy. Your nutritional product should be a pharmaceutical graded supplement that can guarantee its potency.

    Unfortunately most products on the market are not in this category. And with supplement companies doing a good job marketing, this is a bad combination for getting quality products in the hands of consumers.

    I believe the manufacturers have a responsibility, but if they are not being held accountable then in a business sense they don’t see a need to create quality. Personally I feel that’s bad business.

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