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Supplements guru sues over his own product

April 29, 2010 |  2:09 pm

The world of dietary supplements is unpredictable and sometimes, well, zany. But here's a story that should give pause to anyone lured by the extravagant claims of many supplements makers.

Gary Null, a nutrition and fitness guru, critic of conventional medicine and hawker of dietary supplements on his website, filed a suit Monday with the Supreme Court of New York County against one of his own herbal supplements -- or more specifically, a company that provided some of its nutrient ingredients. The suit alleges that after taking two daily doses of the product, Ultimate Power Meal, for a month, Null fell ill with "excruciating fatigue along with bodily pain" and bleeding "from within his feet."

A visit to his physician revealed extremely elevated levels of Vitamin D in Null's body, which led Null to investigate the contents of the Ultimate Power Meal. Null's complaint charges that the defendant in the civil case, Triarco Industries Inc., had erred in preparing the Vitamin D source for the product, making it 1,000 times more potent than the product's content label claimed. The suit seeks damages of $10 million.

As The New York Post, which broke the story, observes, "not exactly a ringing endorsement" of his own product.

Null consumed his power meals after his symptoms appeared, believing the product "would help him and relieve his condition."

"Fortunately, only one lot of Power Meal was defective and none of the product reached the retail market," says Null on his website's "store." But the New York Post, citing papers filed in the suit, reports that "six consumers were hospitalized with severe kidney damage" and that Null, while ill, "had dozens of his customers calling him, as well as threatening and condemning him."

It's not at all uncommon for the content of dietary supplements to contain doses wildly different than those indicated on their labels--and that's when nutritional contents are listed on labels, which is not always. (At least one commercial lab regularly issues reports documenting the mislabeled and unlabeled contents of dietary supplements.) 

New federal rules make the manufacturers of dietary supplements subject to inspections to ensure "good manufacturing procedures." Those rules aim to improve quality problems that have long plagued the supplements industry. But for the smallest manufacturers, those regulations are just now coming into force. Otherwise, the Food and Drug Administration's role in regulating dietary supplements is very limited: Dietary supplements are allowed onto the market without prior approval from the FDA. So, unless the agency has reports that indicate a product may be harmful, it can stay in broad circulation indefinitely.

So, buyer beware -- and apparently that goes for Gary Null, whose "Ultimate Power Meal," fortunately for him, didn't quite live up to its name.

As for Vitamin D toxicity -- this is controversial. Most of us do not get enough of this vitamin, which our bodies produce in response to sunlight as well as take in from dietary sources, and evidence is mounting that adequate Vitamin D levels are important for staying healthy. But the National Institutes of Health have said that 50 micrograms, or 2,000 international units, is the safe daily limit for anyone over a year old. The Vitamin D Council, headed by Dr. John J. Cannell, counters that adults can tolerate more than 10,000 IU daily safely.

--Melissa Healy

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Comments (4)

The FDA approves drugs that have problems on a regular basis - and the public only finds out about it after hundreds or thousands get sick or injured. The FDA is backed by big pharma. Nutritional supplement makers that are reputable preform assays on a regular basis to make sure the product is safe. Gary Null only works with companies that have an A+ track record - but errors happen. Fortunatly Gary caught it early because he insists on regular assays. His prioriety is always the health and well being of people everywhere - whether they are his customers or not. For 35 years, he has been providing nutritional counseling for free. Unfortanetly, he fell ill because of the mistake of one subcontractor making a mathematical error - too much vitamin D. Gary has every right to sue, to be compensated for his crisis, and to send a message that supplements should be regularly tested. I think thats about as ethical and humane as one can be - speedy recory Gary! And lets hope that this puts all companies on guard to check their products regularly.

Respectfully, the above article by the Los Angeles Times, regarding the matter that Gary Null & Gary Null & Associates, Inc., filed last Monday, April 26, 2010, in the Supreme Court of the State of New York in New York County, alleges that the defendant, Triarco Industries Inc., ("Triarco") is the manufacturer. In addition, that health guru Gary Null, upon taking two daily doses of the product, Gary Null's Ultimate Power Meal, for a month fell ill, and that it is not uncommon for such an incident to occur within the health care industry. But, the main issue with this case is regarding the Inadequate Safety Testing of a product, Gary Null's Ultimate Power Meal, that led to the distribution of a manufacturing defected product of great significance mixed by Triarco, a company that is "dedicated to pharmaceutical excellence in both product and service." In fact, "Triarco is ISO 9001:2008 certified by the National Science Foundation (NSF), and Underwriters Laboratories (UL)." Here, this matter is regarding the unfortunate wrongdoing of a company, namely Triarco, that was subcontracted by the manufacturer, Archon Vitamin Corporation ("Archon"). To be clear, the defendant in this case is not the manufacturer, as alleged by the above article, it is the subcontractor of the manufacturer, and Gary Null was ill advised by Archon Vitamin Corporation, because he was never informed that such a relationship even existed between the manufacturer and subcontracted company, namely Triarco. Further, Gary Null utilized more of this product than any of the consumers of Ultimate Power Meal, and this is a rare occurrence in that this has never happened before to the plaintiff, namely Gary Null.
Here, in the instant case, the Complaint states that Gary Null fell ill upon taking a significant amount (e.g. 2,000,000 IUs unknowingly of Vitamin D for weeks) of a particular product, namely Ultimate Power Meal. Gary Null, who for more than thirty-five years, has not even had one such incident the like thereof occur before, regarding anything that he has created. Gary Null, indeed, was affected. In addition, the central issue in this case, as previously stated, is not regarding anything that affected Gary Null, (or what he has done, or intended to do); in addition, nor is it about anything that physically happened to Gary Null. Clearly, this case is about the "Inadequate Safety Testing" by Triarco, a leading supplier of premium natural ingredients for the health, nutritional, and pharmaceutical industries. Here, Archon Vitamin Corporation subcontracted to Triarco Industries, Inc, a leading supplier of premium natural ingredients. Indeed, Triarco had a duty to perform proper safety testing, namely scientific assays for their clients, (e.g. Gary Null & Associates, Inc.), as it states on their website, "Triarco maintains two state-of-the-art manufacturing facilities with pharmaceutical-grade testing capabilities and quality control." In fact, Triarco claims to provide "stringent production and laboratory capabilities which allow them to provide the finest products in the industry." Here, Gary Null emphatically demanded that proper scientific assay testing of the potency (and characteristics) of every ingredient of ALL of his products be performed with the highest standards. Indeed, Gary Null, has always demanded the highest standards (e.g. random sampling and testing to ensure accuracy), for each one of his products be performed, so that they are properly tested, (e.g. scientifically proven safe, tested by assays in order to implement quality control), and in order to provide products for consumers that increase the accuracy of the nutrition label values on his products, (e.g. so that the count(s) of each ingredient is accurate within every product), thereof.
In addition, Gary Null did not know that this task of mixing, and creating Ultimate Power Meal had even been given to Triarco by Archon, and as previously stated, this is the only time that a manufacturer created a manufacturing defect of a Gary Null product in thirty-five years. To be clear, this is the only incident that has occurred in thirty five years of this nature, and upon learning of the improper mixing, (e.g. 1,000,000 IU, instead of 1,000 IU of Vitamin D), Gary Null immediately withdrew the product from the market. It should be noted, that this incident occurred at a point in time, (as it commonly with every one of Gary's products), whereby it was initially released for a small number of individuals (e.g. several hundred), so as to get their feedback on how they are enjoying, and benefitting from a given product. Indeed, it was in this stage that the error was quickly discovered, and the product was removed from the market by going to each of the consumer's residences and picking up this product that contained higher amounts of Vitamin D. Finally, all of Gary Null's products have been properly retested with an ever greater sense of urgency of accuracy out of concern for consumers. Accordingly, if the proper adequate safety testing had been performed by this leading supplier of premium natural ingredients, Triarco, as they claimed to adequately to perform, so as to ensure the accuracy of each, and every one of the ingredient(s) in every unit of their product(s), then this unfortunate incident of distributing a product with a manufacturing defect, would probably never have occurred.

The physiologic dose of Vitamin D that someone working in the sun would get in a couple of hours of noonday sun is 25,000-35,000 iu. People with diabetes, obesity, cancer or MS tend to use up or sequester the D so that it doesn't build up. With testing, 10,000 iu daily has often not been enough to budge blood levels. For myself, 6 months of 10,000 iu was insufficient to raise my blood levels into the optimal range- which based on the new research is 60-100ng/ml.

Null's supplement thus had conservative levels, and it is fortunate that he discovered the manufacturing error during beta testing.

More informatioin: http://www.acupuncturebrooklyn.com/?s=vitamin+D+levels

i'm glad Gary has recovered. It may be better to avoid vitamin mixes - they put another error prone layer of operation and measurement in the production process.



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