Supplemental Health
Last night, my company sponsored an event for our meetup group where our speaker discussed licensing within a pharmaceutical setting, different types of licensing, and advantages and disadvantages to each. During a discussion about the current state of the pharmaceutical industry, I said there should be more exploration into alternative medicines and dietary-supplements as complements to pharmaceuticals in fighting disease and sickness. As one person argued, the words “natural” and “healthy” are not necessarily interchangeable when describing these products. To emphasize her point, she said, “just because poison ivy is natural doesn’t mean I’m going to put it in my salad.”
Coincidentally, today I picked up my Men’s Health magazine to do some casual reading, and I came across an article they had done called “Beyond Balco: The Untold Dietary-Suppement Scandal,” describing a problem with a number of over-the-counter products where molecular ingredients are structured and behave suspiciously like steroids (click here for the online article). It opened with the story of Derek Cornelius, president of the supplement company Syntrax Innovations, which released a fat-loss product called Triax Metabolic Accelerator in the late 1990s. Sales of the product were brisk, and it quickly became the company’s best-selling product. However, in November 1999, a series of complaints filed with the FDA showed that Triax might have been responsible for causing abnormal thyroid function as a side effect. The culprit was the active ingredient in the product, tiratricol, which is a naturally occurring chemical that is structurally similar to a powerful thyroid hormone.
According to the article, when Cornelius was asked at one point why he would risk both an investigation into his products by the Food and Drug Administration (FDA) and a plethora of lawsuits just to make a supplement, he was seemingly surprised by the question.
“That was the last thing I thought the FDA would target,” [Cornelius] says. “To me, it appeared to be well within the parameters set by the federal government. It was naturally occurring, and studies showed it was safe.”
In fact, when tiratricol was prescribed by European doctors to treat overactive thyroids, it had been proven to be a safe chemical. As a result, the FDA labeled Triax as a drug and not as a dietary supplement, and finally pulled the product from the market in 2000. In spite of a multi million dollar settlement in a class action law suit, Syntrax admitted to no wrongdoing.
The article serves as a guide to an industry that has been under-regulated by the FDA, and as a result is providing drugs, not supplements, to its customers. While it certainly makes no claim that all of these products are bad, caution is warranted whenever using something other than food to achieve goals such as weight loss, bulking up, or even maintaining a healthy balance of vitamins and minerals.
I do remember using a tea called “Dieter’s Green Tea” in order to help me maintain a healthy weight. I hadn’t considered it a supplement, but had read the label and felt that its natural ingredients were unlikely to cause me any harm. I later read about June Grell, a healthy 37-year-old who had drunk the tea daily in order to lose some weight and keep it off. After several months of drinking the tea, June died suddenly in her sleep, which would be later traced back to her use of the tea.
The tea contained an active ingredient called “senna”, a laxative. If overused, it could cause a serious electrolyte imbalance which, in some cases, could lead to arrhythmia and heart failure. The tea box didn’t mention any of these dangers, or even that the ingredient was a laxative. Because all of the ingredients in the product were herbal and naturally occurring, the FDA didn’t require any tests for the effectiveness of claims or the safety of the product. Surely, had this been a prescription-based product, it would have received the FDA’s strictest label, the black box. I found an article on this event from the Caremark Health Resources web site, which provides some fascinating insights as to how unregulated the herbal and supplement market is.
Needless to say, I stopped drinking the tea.
Regulation of such products has tightened up in recent years, as is evidenced by a few people I know who sell juice-based supplemental products. They are required to list all ingredients and can claim the product is all-natural, however, there are very specific rules they must follow in order to describe what the product can do. I know, for example, they can’t claim their product cures disease. I don’t know, however, what kind of safety regulations they must follow, or if they must perform clinical trials before a supplemental product comes to market. My Men’s Health article does provide some interesting insight into this industry and its current state, and gives advice as to what to look for when buying these supplements.
Personally, I’m very weary of using any such supplements because of my experience with the Dieter’s Tea, but that’s not to say there isn’t something out there that might be helpful to you. What’s your experience with dietary supplements and herbal products? How do they make you feel? Do you feel safe using them? Did this or any of the linked articles make you change your mind? Let me know!
Regarding dietary supplements, there is really very little regulation over the safety or efficacy of them. Only if a supplement manufacturer makes what is called a “health claim”, i.e. a claim which connects the substance to a known medical condition, do they come under stricter FDA rules. Most supplement labels, however, make either no claim or what is known as a “structure and function claim”, where the manufacturer is allowed to make vague connections such as “this products helps to promote breast health” or “a healthy prostate’. With such claims, there is no pre-approval required (unlike a health claim) and all that is required by the FDA is that the manufacturer keep substantiation in its files regarding any connection between the supplement and the vague statements it makes. In any case, I am also weary of using something just because it is herbal or natural, because you don’t really know what is in the substance and whether it has caused any harm or is even effective. Currently the only ones I use are amino acids, but there is nothing really controversial about these.
Regarding dietary supplements, there should be more exploration into alternative medicines and dietary-supplements as complements to pharmaceuticals in fighting disease and sickness.