There have been a couple of rumors floating around the Internet about some of my past business experiences. I have decided to set up this page so that I can set the record straight. Here goes:
The FDA, Phase 2 Carb-Blocker & Omni
In 2001, the FDA contended that our combination of aspirin with the nutrient glucosamine for joint pain was not allowed. We disagreed with the FDA publicly and the industry watched our debate as reported in The Tan Sheet, an industry trade magazine. The employees at the FDA who sent us the letter made a mistake. Of course, the FDA does not make laws. Instead, they interpret and police laws made by congress. But the language in some of the laws is complex, and accordingly the FDA sometimes misinterprets them. This was the case with combination products. The FDA sent us a notice saying we cannot combine a nutritional supplement with an OTC drug. But they cited nothing in the law to support their theory. So we challenged them publically, asking for them to show us where in the law it prohibits this and also pointing out that companies have been combining nutrients with OTCs for many years. The pharmaceutical and nutritional industries closely watched our response and waited for the FDA to respond. But no response was forthcoming — a clear indication to the industry that they agreed they were mistaken on this issue. So we kept the product on the shelves, as did the makers of Bayer along with dozens of other companies marketing these combination products. For example, today you can buy Bayer Aspirin combined with vitamin C. Bayer did not get FDA approval for this combination because the law does not require such approval. http://aspirin.com/scripts/
In 2004, the FDA asked us to change a label claim on a product called Phase 2 Carb-Blocker because the clinical evidence did not meet their standards. Since the active ingredient was supplied by a 3rd party company who controlled the clinical studies, we gladly agreed with the FDA and made the labeling changes. Those two issues were with a company called Omni, which I was a minority owner of. In 2008, Omni stopped operating as a business and had no employees, revenue or physical location due to unsupportable debt accrued by former management. At around that time, the company no longer had staff to prepare the quarterly filings with the SEC. In 2008, the SEC sent the company a notice that because Omni had not filed required periodic reports, its stock could no longer be traded and Omni’s securities registration was revoked. This was really not a regulatory issue so much as the natural course of a company closing down.
The California “Lead” Story
Another regulatory issue being discussed online was a 2011 disagreement we had with some county level district attorneys in California. They alleged that one of our products didn’t contain a certain ingredient on the label and was therefore falsely advertised. We provided testing that proved that it did contain the active ingredient. They also alleged that we had more lead in a few products than is allowed in California. We showed them evidence that a California judge had previously approved an allowance of a higher lead amount for us because our herbs had naturally occurring lead from the environment, such as lead picked up from the soil by plants. In fact, these amounts of lead in some of our herbs was actually less than the amount allowed by all states other than California. California has a rule that almost no lead can exist in a food if it comes from the manufacturing machines. The problem is that no one can easily determine whether these trace amounts of lead are from the machines or from the soil. But we were prepared to resolve the matter in front of a jury because the evidence was in our favor. However, in the end, some of our senior managers convinced us that the trial costs with the DA’s would cost more than the settlement they were requesting.. Some people seem to think we were “ordered” to pay a settlement. We were never ordered to pay a settlement as the case never went to court. So there was never any finding of guilt whatsoever. We settled because it would have cost more to fight than to be right.