Read these statements made by the following supplment companies and organizations as featured in The Hansen Files investigative report from Sunday, March 18th, at 7pm/6c:
- Wright Enrichment, Inc. (http://www.thewrightgroup.net/)
- GNC (http://www.gnc.com/home/index.jsp)
- Council for Responsible Nutrition (http://www.crnusa.org/)
- Natural Products Association (http://www.npainfo.org/)
Statement by Wright Enrichment, Inc. to Dateline NBC:
Wright Enrichment, Inc. (“Wright”) is a small family owned company which has provided for many years numerous health beneficial vitamin pre-mix blends to a variety of customers. In regard to the Total Body Formula matter, while a great majority of cases have settled, a number remain in litigation in the State of Georgia. As a result, we trust you understand that Wright Enrichment is not at liberty to fully address some of the issues raised as litigation is still pending, consequently, we hope that your report will not draw any adverse inferences therefrom as to Wright Enrichment.
For years preceding this litigation, Wright produced, without incident, the vitamin premix blend component of the Total Body Formula. In 2007, apparently for cost cutting reasons, Total Body Essential Nutrition, Inc. (“Total Body”) changed its product manufacturer to a company named Texamerican Food Blending, Inc. (“Texamerican”), without Wright’s knowledge.
Unbeknownst to Wright, Texamerican did not possess the product’s vitamin premix blend formula. Instead of securing the formula from the previous manufacturer and ask Wright to produce the vitamin premix blend it had previously produced for that manufacturer, Texamerican believed that one of its employees and/or a independent contractor could reverse engineer the blend.
Notwithstanding, Texamerican proceeded to order from Wright a vitamin premix blend unfortunately containing elevated selenium levels. Wright produced the Texamerican blend to Texamerican’s exact specifications. Unfortunately, Texamerican’s specification/formula was high in selenium. On at least seven occasions before and after production of the vitamin premix-blend, for dosage confirmation, Wright provided Texamerican documents accurately stating all ingredients and vitamins present in the blend, including its selenium content. In fact, independent laboratory testing has confirmed that Wright’s premix blend contained what Wright represented it contained in those certificates of analysis and documents.
Wright is a vitamin premix blend producer. Generally, when a customer places an order, Wright is not told how a given blend will be utilized. Wright does not generally know whether its blend will be co-blended with a competitor’s, or how it will be diluted. In this case, Wright was blindfolded to the fact that Texamerican had no qualification and/or competence to formulate vitamin premix blends. Wright was blindfolded to the fact it had already produced the vitamin premix blend Texamerican was trying to reverse engineer. Wright did not know whether its vitamin premix blend was going to be co-blended, and Texamerican did not inform Wright of the vitamin premix blend’s dilution rate.
When initial complaints were reported, Wright requested the final product label from Texamerican, but to no avail. Being unaware of the product’s identity, Wright could not initiate a recall. Moreover, because Wright is not the owner of the product, Wright had in fact no right at any time to initiate a recall.
It is compelling that had Wright Enrichment been told to produce the same blend it had produced in the past for Texamerican’s predecessor, the Total Body Formula would have been fit for human consumption.
Equally compelling, if not more so, is the fact that after it had produced the Total Body Formula, but before it was released in the stream of commerce, Texamerican had its own employees sample the Total Body Formula. Some Texamerican employees became almost instantly and violently ill. Witnessing the “effect” it had on co-workers, some Texamerican employees refused to sample the Total Body Formula. Stunningly, with the sampling outcome in hand, Texamerican proceeded to release the Total Body Formula in the stream of commerce as fit for human consumption. In sum, Texamerican failed in its attempt to reverse engineer the vitamin-premix blend it asked Wright to produce, then with knowledge the product it had manufactured made people ill, Texamerican released it to Total Body as fit for human consumption.
Texamerican and Total Body denied any liability in the Gurley trial! Wright admitted to being at fault in the Gurley trial because, in hindsight, Wright should have raised more questions about what was being ordered. The fact that the formula Texamerican provided to Wright appeared to be imperfect should have raised a red flag to Wright. Wright should have refused to produce the blend.
As a result, Wright has been and remains willing to fairly compensate consumers that have been injured by the Total Body Formula. Wright has also taken steps necessary to ensure a similar incident does not re-occur and protect consumers and itself from companies like Texamerican. However, Wright believes the Edward Gurley jury verdict was the result of a jury inflamed by improperly admitted evidence and arguments of counsel. Wright also believes that the jury verdict was a result of an apparent secret deal/settlement entered into days before the start of trial between Plaintiffs and Texamerica and Total Body. Wright was prevented from learning the exact nature of this secret deal and Wright was not allowed to disclose to the jury the fact a secret deal/settlement existed at the time of trial. Therefore, Wright Enrichment is now pursuing an appeal.
WRIGHT ENRICHMENT, INC.
First, you have told us that Dateline NBC intends to use as an on air source a consumer who purchased a selenium product called Total Body Formula at a GNC store in Lawrenceville, Georgia approximately four years ago. The following points are specific to that element of your story.
This product was not manufactured by GNC but instead is a third party product GNC retailed in its stores. It’s our understanding the product was sold at other retail outlets as well.
This product had very limited distribution in GNC stores. GNC has over 5,000 US GNC store locations and this product was sold in less than 50 GNC stores.
It’s our understanding the problem with the product involved a manufacturing error by the manufacturer where excess selenium was inadvertently added to the product. This was not a contamination issue. This manufacturing error occurred prior to when the new Good Manufacturing Practices (“GMPs”) regulations came into effect for dietary supplement products.
As soon as GNC learned that there was a problem with the product, it alerted the stores to remove the product. The product has not been sold since its removal, which was nearly 4 years ago.
Second, without specifics GNC cannot comment on any other dietary supplement products that purportedly failed testing or were contaminated.
However, it is important to remember that all manufacturers of dietary supplements are required to follow GMPs when manufacturing dietary supplements.
These regulations were enacted by the FDA in 2007 and cover an expansive list of required manufacturing processes and procedures ranging from personnel, physical plant and grounds, equipment and utensils, production and process control, batch record production, laboratory operations, packaging and label operations, holding and distributing, and record keeping requirements. The aim of the regulations is to ensure dietary supplement quality throughout the manufacturing, packaging, labeling, storing and distribution of dietary supplements.
The GMP regulations are relatively new and the FDA has been actively inspecting manufacturing facilities to ensure compliance. The GMP regulations were enacted in June 2007 and had a three-year phase-in period depending on the size of the company. Companies with more than 500 employees had until June 2008 to comply, companies with less than 500 employees had until June 2009 to comply and companies with fewer than 20 employees had until June 2010 to comply with the regulations.
We believe that, as the FDA continues with its GMP inspections, manufacturing issues with dietary supplements will be virtually eliminated.
By law, every single bottle of dietary supplments sold should contain what is on the label. More than 150 million American take dietary supplments each year as part of their health regimens with little evidence of widespread adulteration or contamination of ingredients. We take seriously the allegations of fraudulent laboratory practices raise by this report, and urge FDA to use its ample legal authority to take legal action against the companies involved. Meanwhile, consumers should buy brands from companies they know and trust.
Steve Mister, President & CEO
Council for Responsible Nurtrition
Statement by the Natural Products Assocation to Dateline NBC:
The Natural Products Association is the leading representative of the dietary supplement industry with over 1,900 members, including suppliers and retailers of vitamins and other dietary supplements. NPA President Jeff Wright comments on the regulation and safety of dietary supplements:
“Consumers can trust what they read on the labels of dietary supplements. We share the concern about the issue of ensuring that products contain what the label claims and are not contaminated. This issue is highlighted, from time to time, in most consumer products industries, including foods, drugs and toys.”
“The Natural Products Association supports the goal of superior quality within our industry, other industries and the government. Fortunately, consumers are smart enough to understand that a few or occasional lapses in quality assurance should not translate into suspicion of an entire category of products, especially one with a strong history of safety. Otherwise, people may not eat eggs, spinach, tomatoes or pistachios today.”
“NPA has long supported government and industry actions to both produce dietary supplements according to good manufacturing practices and eliminate drugs wrongly labeled as supplements. Products that contain undeclared drug ingredients are not dietary supplements. These products are illegal drugs, and they have no place in the legitimate marketplace.”
“Selling products that contain illegal substances is a crime. Anyone who manufactures or sells these illegal products intentionally should be prosecuted to the full extent of the law.
“NPA has been steadfast in its support for increased resources for the Food and Drug Administration. We also support government action against any laboratories that may use improper testing methods. We fully support strong rules to make sure that what’s on the label is what’s in the bottle. NPA has been a leader in industry efforts to attain this goal through our TruLabel and GMP certification programs.”
“It’s important to note that dietary supplements help millions of Americans address nutritional deficiencies and maintain and improve their health. NPA provides information about the regulation, safety and benefits of supplements online at NPAinfo.org/consumers."
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