As a very health-conscious company and the leading formulator of supplements for mood and mental health, we are completely committed to safety when it comes to the ingredients in our products.
Sometimes people ask us about titanium dioxide, an ingredient used in association with our products. Let's take a deep dive.
Titanium dioxide is a naturally occurring mineral that comes from the earth and is often found in consumer products like food and cosmetics. It comes in the form of a fine, white powder and is commonly used to provide whiteness and opacity. At Hardy Nutritionals, we use it to provide whiteness in the veggie capsule for visual consistency.
Is It FDA Approved?
Yes! The US Code of Federal Regulations specifically states that titanium dioxide can be safely used in foods as long as the quantity of titanium dioxide does not exceed 1 percent by weight of the food.
The amount of titanium dioxide in our products is less than or equal to one percent of the empty capsule weight, about 1 mg, making it perfectly safe to ingest. Because we are always open to improvements and believe in giving you the best micronutrients possible, we regularly evaluate the state of evidence for many of our ingredients and make adjustments accordingly.
The raw materials we use in our products at Hardy's can sometimes have varying shades of color as a result of natural causes, like harvesting or moisture content. It can be distressing to consumers when the color is different between batches, and we feel it is important to provide a consistent look so you can feel comfortable with each purchase. As adding titanium dioxide to the capsule doesn't affect the nutritional content in our products, we feel it is a good and safe solution for this problem.
Some consumers express concern regarding a potential link between carcinogenic risks and titanium dioxide in humans.
To date, no research shows that titanium dioxide in food harms your health.
In the past, some data noted titanium dioxide exposure has been linked to tumors in animals and oxidative stress in human cancer cell lines.
The literature is very clear: there are only two routes of exposure that produce these effects. The first is inhalation. In animal studies, neither oral ingestion nor injections of titanium dioxide under the skin or into the abdominal cavity produced a significant increase in any type of tumor in mice or rats. An increase in lung tumors in rats was reported after inhaling titanium dioxide dust at a concentration of 250 mg/m3 for two years. This would equate to the rats' inhaling approximately 30 grams of titanium dioxide over the space of two years. The human equivalent of such inhalation would be 2.1 kg or 4.6 pounds over two years.
The second route of exposure is nanoparticle exposure. Nanoparticles of many different mineral oxides–including iron oxide, magnesium oxide, copper oxide, silicon dioxide, manganese oxide, and non-minerals like microcrystalline cellulose–can pass through cell membranes remaining predominantly as inorganic oxides and cause significant oxidative stress. Again, this distinction is clearly a function of particle size and chemical form where extremely small particles are clearly harmful while the larger particle sizes are not. Nanoscale titanium dioxide is not currently approved as a food additive. In adherence to this regulation, the particle size of the titanium dioxide used in our products is safe.
There is no concrete evidence that consuming small amounts of titanium dioxide orally will lead to negative health outcomes. Rest assured that Hardy’s follows the strict guidelines set by the FDA, and we follow Good Manufacturing Practices (GMP) to provide the highest quality products to our consumers. Our micronutrients continue to be free of gluten, soy, dairy, GMOs, and allergens, and they are safe for a vegan diet. As we regularly review the research, we will continue to adjust our products to ensure their safety and performance.