Is There a Risk in Premix Overages?

Everyone knows nutrients can degrade over time, whether from heat, light, pH, or some other environmental influence. In order to ensure nutrient content claims on food and dietary supplement products, manufacturers can employ overages for ingredients they know are likely to degrade. But overages should not be abused. As much as manufacturers should be concerned with not delivering enough nutrition, they should also be wary of delivering too much.

Folic Acid

A curious study on folic acid, published in September in Food Chemistry, brings this concern with overages to reality.

When researchers at the Max Rubner-Institut in Germany analyzed nine popular vitamin juices sold in Europe and fortified with folic acid, they found that manufacturers were adding extra amounts of folic acid to all of these juices-which makes sense. Folic acid is highly sensitive to oxygen, low pH, and light, so there are plenty of opportunities for vitamin juices to lose their folic acid.

But extra folic acid isn’t necessarily safe for consumers. In fact, researchers have warned that it can mask vitamin B12 deficiency in humans. The potential risk is all the more concerning when considering that all of the juices included in the Food Chemistry study, even after a year’s storage, still exceeded their declared label amounts of folic acid. The researchers concluded that consumers of these products-especially repeat consumers-may be in danger of exceeding tolerable upper intake levels of 1 mg of folic acid/day as established by the European Food Safety Authority. Manufacturers are evidently challenged by the desire to use too much of some nutrients.

Premixes

Balancing overages for the sake of label claim integrity and consumer safety can be even more challenging when manufacturers use premixes. These tailor-made solutions can contain multiple vitamins, minerals, and other additives, all of which have their own stability issues and potential to react with other nutrients. Thankfully, premix formulators can help manufacturers figure out which nutrients to use and at what concentrations in particular products.

“It’s not as easy as just putting 25% B vitamin overages into a premix,” says Jeremy Bartos, PhD,  scientific and regulatory affairs manager for customized solutions at Glanbia Nutritionals NA Inc. (Carlsbad, CA). “If the premix contains riboflavin, for example-riboflavin is incredibly sensitive to light, so putting riboflavin into a clear package isn’t going to work.” Bartos stresses that knowing all of the manufacturing conditions of a product will help premix formulators make educated decisions on how much overage to recommend.

The forms of each nutrient are critical, as vitamin A, for example, is available as vitamin A acetate, vitamin A palmitate, and even beta-carotene. Each of these vitamin A forms can interact differently with its environment.

Special care should be directed at certain nutrients, too. Alison Raban, a food technologist with BI Nutraceuticals (Long Beach, CA), notes the importance of understanding the metabolic differences between, for example, fat-soluble and water-soluble vitamins.

“The human body processes them differently,” says Raban. “Some of the water-soluble vitamins aren’t as likely to hurt the consumer because, more likely than not, the consumer is just going to pass them out and not actually absorb them. But fat-soluble vitamins are more likely to be absorbed. Sometimes, those can build up in the liver or kidneys, and you can start having issues.”

FDA’s Stance

Is FDA likely to go after companies that aren’t meeting, or are vastly exceeding, their nutrient claims?

Ingredient suppliers say the agency doesn’t look as though it’ s putting much emphasis on nutrient content claims during GMP inspections, but it’s worth noting that GMP guidelines for dietary supplements place importance on a manufacturer’s assurance not just of product identity, but also of product potency. The Council for Responsible Nutrition (Washington, DC) adds that FDA may take a sample and product labeling for analysis during GMP inspections. And if FDA isn’t testing your product’s potency, third-party labs might.

According to 21 CFR Sec. 111.260, a dietary supplement manufacturer must have a master manufacturing record on file, which should include not just a detailed list of all ingredients used in a product, and their precise measurements, but also a statement of any intentional overages and the expected yield of each nutrient at each stage of the product manufacturing process.

Making sure overages are not in excess can help protect customers, and it can also protect against an added expense.

Robby Gardner
Associate Editor
Nutritional Outlook magazine
robby.gardner@ubm.com


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