Holistic Misconceptions about TheraSol
Holistic Misconceptions about Ingredients in TheraSol
Holistic practitioners are occasionally concerned about some of the ingredients in TheraSol. We thoroughly researched those objections and found that one concern was indeed valid, but two were not, despite widespread repetition in the lay holistic literature.
Fluoride: Justified Concern
TheraSol was developed in the 1980’s. Fluoride was an ingredient in the original formulation based on the recommendations of a 1988 FDA monograph on mouth washes. FDA monographs are ingredient guidance for industry based on reviews of the literature by scientific panels, which concluded that it was highly effective in reducing caries and safe at the recommended concentration.
However, fluoride comes from many sources today; mouthwashes, toothpastes, the water supply (and all foods cooked or prepared with fluoridated water). Consequently, the total body dose can exceed the recommended limits. Since fluoride wasn’t an essential ingredient in TheraSol, we removed it. TheraSol is now fluoride-free.
FDC Blue No. 1 Popular Misconception
Another common holistic misconception is that all food colorings are toxic. To be fair, that was actually true prior to 1927, but dyes used then have all long since been replaced with non-toxic colorants that have been exhaustively tested for safety by both U.S. and European food safety agencies.
In the early 1900’s, artificial, so called “lake” food dyes were made from coal tar extracts that had high levels of arsenic and mercury. Even worse, some farmers were using those dyes to mask questionable food products. People died from them. The practice was so widespread that Congress passed the Food and Drugs Act of 1906, which charged the US Dept of Agriculture (USDA) with overseeing the use of dyes. Unfortunately, the restrictions were only voluntary and the Dept. of Agriculture was overly cozy with the food industry and the practice continued. In 1927, Congress responded by creating the FDA to oversee the food industry more closely. In 1938, Congress finally made industry compliance mandatory and banned outright the use of all “lake” dyes in foods.
Food dyes made headlines again in 1950 when many children became ill from Halloween candy colored with 2% FD&C Orange No.1. An investigation discovered that it contained pesticide residues. That led to the passing of the Delaney Clause in 1960 that banned all pesticides or other potentially carcinogenic ingredients from food products and dyes. See research link below.
The colorants used today are heavily regulated by the FDA and exhaustively tested prior to approval and use. Moreover, even after approval, colorant manufacturers must sent samples from every batch they make to the FDA, where they undergo at least 10 analytical tests for impurities and compliance with federal standards before being certified for use. The FDA also inspects every facility that manufactures foods and cosmetics before they are allowed to make products, including the plant that makes TheraSol. I can assure you, the FDA inspectors are meticulous. Everything is documented, including: ingredient purity and sourcing, storage conditions, manufacturing and bottling processes.
Like saccharin, the notion that modern colorants are toxic remains widespread in the holistic community. Rather than trying to change long held beliefs, we tried eliminating colorants like we did with saccharin for our holistic dentists. Paradoxically, they found that most of their holistic patients wouldn’t use it … because it looked like plain water. They didn’t think it worked. We ultimately had to destroy thousands of gallons of colorless TheraSol no one would use.
Blue TheraSol seems to be a marketing necessity.
Saccharin Popular Misconception
The actives in TheraSol have a slightly bitter aftertaste. Rather than adding caloric sugar, we use non-nutritive saccharin to neutralize the bitterness. That concerns some people because many lay holistic websites and publications still (mistakenly) claim that saccharin causes cancer. That claim originated from research in the late 60’s showing that high doses of saccharin caused urinary cancers in rats and mice. Accordingly, from 1970 to 2000, the FDA mandated that all foods containing saccharin bear a risk of cancer warning label.
The FDA removed the warning label in 2000 when researchers discovered the mechanism whereby fluoride caused cancer in rodents. The mechanism was determined to be mechanical rather than chemical. Unlike human urine, rodent urine has a high pH with high levels of calcium phosphate and proteins. Those combine with saccharin to produce microcrystals that damage the lining of the bladder. It was the chronic damage from abrasive microcrystals that led to tumor formation, not the saccharin. In humans, the lower pH, phosphate and protein levels don’t enable the formation of microcrystals. Accordingly, the FDA, the U.S. National Toxicology Program and the EPA have all removed saccharin from their lists of carcinogens.
Unfortunately, it’s difficult to undo 30 years of inappropriate FDA warning labels. It’s become ingrained in holistic culture and holistic websites are still promulgating the original cancer story without no mention of subsequent studies dismissing those early concerns. Rather than trying to convince people that current research is more sophisticated and trustworthy than studies from the 1960’s, we decided it was easier just to make a saccharin-free version of TheraSol. For patients that can’t be re-educated. We now offer a TheraSol sweetened with xylitol instead of saccharin.