Natural Products Insider

JUL-AUG 2019

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36 INSIDER July /August 2019 rates depending on surface area [and] exposure to oxygen, so that's one of the things you have to take into consideration. Overages are going to be different in those different forms." Additionally, Shao noted the manufacturing process related to a particular delivery form can affect how much overage is needed. Tableting, for example, is a harsh process that can cause ingredients to degrade, "so there may be encapsulation approaches that can be used for ingredients that protect them during the tableting process or, perhaps, avoiding tableting and going to something that is less harsh, like a capsule, for example, instead of a tablet," Shao said. Perhaps, he suggested, equally important to determining how much overage to add is taking measures to reduce the amount of overage needed. By addressing factors that can cause ingredient degradation, manufacturers may be able to reduce the amount of overage needed for a product. This approach comes with a bonus: cost reduction. "Approaches can be taken to try to minimize the amount of overage that's needed because … adding more adds more cost," Shao said. "Certainly, that's something that manufacturers want to keep down is their cost." Packaging is key a factor to improve stability, and thereby reduce degradation of actives. Some packaging can protect ingredients from light and oxygen, which can degrade actives. Secrist implored manufacturers to consider "anything you can do to minimize the exposure to oxygen in the packaging." Another important consideration when determining overage amounts, Secrist said, is the target demographic. "Who are you targeting?" he asked. "Are you targeting women? Are you targeting the elderly? Are you targeting children? Are you targeting specifi cally infants? There's not a lot of data for infants and children." He advised "trying to be conservative" when determining overage amounts for vulnerable populations. "Trying to put more overage in that might be approaching potentially upper safe limits is not as good as potentially trying to lower the shelf life," he said. How Much Is Too Much? According to Shao, "At some point, an overage can become an adulteration." Despite potential safety concerns, FDA has not established maximum amounts for dietary ingredients in supplements. "The agency … does not set maximum levels, what we call regulatory maximums, for the amounts of nutrients, vitamins, minerals [or] other ingredients that can appear in a dietary supplement," Shao explained, adding regulatory maximums are "different for different nutrients or ingredients. What determines [a maximum] is quite complex, so it makes it diffi cult for the agency to draw a fi ne line." FDA's concern, Shao suggested, is safety. "If the overage that's added for a given nutrient or collection of nutrients in the formulation or ingredients in the formulation result in the product being unsafe, then that's a problem," Shao said. "But if it's not—if it doesn't result in safety issues—then really FDA is not going to be concerned." It's important to understand which ingredients pose a greater threat to safety when consumed in larger doses. Fat-soluble vitamins, for example, pose a greater threat than water-soluble vitamins, which are excreted quickly when consumed in excess. Manufacturers can turn to data on tolerable upper intake levels for various vitamins and minerals, established by the National Academy of Sciences and included as part of the dietary reference intakes (DRIs) nutrient recommendation by the National Institutes of Health (NIH), for guidance on safe amounts of certain nutrients. "You have to know what the upper limits are and make sure that as you're formulating you stay away from those upper limits," Secrist said, "especially if you have products that are targeted specifi cally to the demographics with children, or pregnant or lactating women." Did it Work? A critical piece of the overages pie is making sure the fi nished product does, in fact, maintain at least 100% of the active ingredient amounts at the end of shelf life. There's only one way to be sure: testing. Accelerated stability studies, which subject a fi nished product to harsh conditions to predict long-term shelf life, are a useful tool for manufacturers, but shouldn't mark the extent of stability testing. "The ability for accelerated studies to predict real time … can vary tremendously depending on what ingredients you have in your formula and then what dosage form you're looking at," Shao said. "What manufacturers should do is start out with accelerated, but ultimately [rely on] what they call 'real time stability,' which is just monitoring the stability of the ingredients under ambient conditions." Additionally, Secrist noted, products need to be tested at the time they're released to ensure they contain the amount of overage determined necessary by stability studies. Ultimately, stability studies can help manufacturers understand the effects of time, temperature and oxygen on a product to help determine how much overage is needed. "Make sure that overage has been determined to be safe and then make sure it has that amount at time zero—at the time of manufacture— so that it's going to make it through the shelf life," Secrist said. Contract Manufacturing: Efficacious Doses Looking for More on Overages? Overages are tricky, but can be mastered with appropriate expertise and knowledge of regulations and best practices. Tune into the "Intentional ingredient overages – webinar" to hear from experts on legal concerns, regulatory considerations and best practices to ensure products contain declared values throughout shelf life. naturalproductsinsider.com/regulatory/intentional-ingredient-overages-webinar Scan Here

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