Who pays for product safety and quality?

Anne Hart has lots of questions about the quality and safety of nutritional supplements, 19 questions to be exact. They revolve around product integrity, contamination, mislabeling (think sibutramine), FDA oversight and so on.  A nutrition columnist for Examiner.com, Ms. Hart has several ideas for matching products to their labels,  all of which create more questions about the testing of every pill, powder, gel and liquid that could be considered a nutritional supplement.

The basic premise of her column is that a lab — probably a lot of labs — should test each nutritional supplement to see if it contains what the label says. The test results should be made available free of charge to consumers whether they are buying online, in a store or from a friend. Who owns the labs and who pays for all those assays and the like? And what entity maintains the databases that must constantly be updated?

Ms. Hart would like the nutrition supplement industry to underwrite the testing costs, but that poses an ethical problem: Just how independent and trustworthy can the labs be if their clients are the  manufacturers? For the answer, look at the uneven history of research firms on Wall Street. The Council for Responsible Nutrition is off the list, too, says Ms. Hart. We can rule out the FDA because it does not have the funding and cannot tax the manufacturers to pay the costs.  Universities have lots of labs and student researchers, but not the money to conduct tests.

“What about forming a group of consumers that would watch the government agency, the independent testing labs, and the manufacturers?” asks Ms. Hart? The idea may be laudable but it is not realistic. America’s social and economic structure does not have a place for such an entity unless it is underwritten by a foundation. The closest model is the Insurance Institute for Highway Safety. It tests how well vehicles fare in crashes, but insurance companies — not consumers — pay for the publicly available research.

Is there a solution that gives consumers peace of mind that what they buy is what they get?

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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7 Comments

  1. Dan said:

    Most internet and brick and mortar operations in the retail supplement business often have their “mission statement” in prominence, hopefully they think you may not pay much attention to it, yet the say they only sell products that stand up to their standards. The solution is simple, retailers state that if they decide to stock your item, than they can select that item off any order and randomly test it. That is the terms you agree to if you want to sell to them.
    Manufacturers can foot the bill-they brought it upon themselves.

  2. Jim Prochnow said:

    I am a lawyer who specalizes in the development, labeling, distribution and marketing of dietary supplements. In my opinion, there is no ready, comprehensive or feasible solution to the safety and effectiveness frustration expressed by Ms. Hart. Similar frustrations are frequently expressed about other products that we do not fully understand, such as automobiles or computers. I do, however, understand the special attention of consumers about their own health The issuance, in 2007, of the federal regulations concerning current Good Manufacturing Practices, along with the FDA’s increased attention to imported finished food products and food ingredients, will, in my opinion, result in a more reliable supply of safe and effective dietary supplements. Two other non-governmental efforts also contribute to the awareness of dietary supplement companies of the need to have reliable products. One is the program of periodic publication of analytical test results by consumerlab.com of various classes of dietary supplements ;the other consists of the NAD and ERSP national advertising challenge procedurtes and programs of the Better Business Bureau. The NAD and ERSP programs continually challenge dietary supplement, as well as other consumer product companies, to present evidence of the effectiveness of their products. In summary, the quick fix or the fix that Ms. Hart is looking for will not occur. Rather, the coming together of these measures , as well as the increased exhortations of the trade organizations such as the American Herbal Prodcuts Association, the NPA, and the American Botanical Council to their members, will result in more food products whose contents match their labels, both in terms of ingredient presence and claimed benefits.

  3. Hugo Ottolenghi said:

    Good point, Dan, about manufacturers saying that they produce quality products. But the conflict of interest remains: the manufacturer is paying for test and, probably, choosing the testing lab. Can the consumer trust the results? An independent third party is needed.

  4. Hugo Ottolenghi said:

    You are right, Jim, that a combination of forces is more likely to bring about changes. It would be great if industry members challenged each other, as they do through AHPA and other trade associations. I think, though, that consumers will view the associations with skepticism as they are funded and answerable to their members, not to the general public.

  5. Pingback: Product quality: the never-ending frontier of GMP | The Nutritional and Dietary Supplement Law Blog

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