Natural Products Insider

JUL-AUG 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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34 INSIDER July /August 2019 FDA regulations require dietary supplements contain 100% of the ingredient amounts listed on a product's label throughout its entire shelf life. On paper, the concept is easy enough to grasp, but it's no small feat to ensure the effi cacious doses listed on product labels remain until expiration. Starting on the day of manufacture, supplement products combat a host of environmental challenges that threaten stability of the product and its active ingredients. And even before a product is packaged and ready for release, manufacturing processes can introduce variances that can affect how much of an active ingredient ends up in the product, while testing methods can introduce variances that can affect how accurately those actives are measured. To ensure supplements not only meet regulatory requirements, but also provide the effi cacious dose promised to consumers, manufacturers can—and, in most cases, should—intentionally add overages, or surplus amounts, of ingredients listed on the label. Determining the appropriate overage amount, however, is complex and requires consideration of many factors, including ingredient stability, dosage form, manufacturing processes, testing methods, the expiration date of the product and the intended target demographic of the product. On the fl ip side, overages in excess can be considered adulteration by FDA, leaving manufacturers to face a diffi cult question: How much of an overage is enough without being too much? Careful consideration must be paid by manufacturers to ensure overages are correctly implemented to create effective— and safe—products. Overages Are Important Overages have an important job to do: They support product quality by ensuring supplement products provide the potency (and, thus, effi cacy) indicated on the product's label. They also keep manufacturers out of trouble with regulators (assuming overages are implemented effectively to ensure supplements contain 100% of the ingredients on the label at the end of shelf life). To be effective, overages must address the factors that can affect the amount of active ingredients in the fi nished product and how those actives are impacted by time and environmental factors. "There's a number of different issues that will affect the need for overages, and it's different for different ingredients, different nutrients," said Andrew Shao, Ph.D., interim senior vice president, scientifi c and regulatory affairs, Council for Responsible Nutrition (CRN). He advised manufacturers start with the basics: education. Aaron Secrist, vice president, quality and regulatory affairs, NOW Foods, pointed to key factors that can affect the amount of active ingredients in a fi nished product and can be addressed via overage. "The fi rst one, and maybe the most obvious, is stability of the product," he said. "You have to be sure for those analytes that have a tendency to degrade over time … you have an overage in them, so as the product starts to degrade and lose some of that product that even at the end of the shelf life of that product you still have 100% of what you claimed on the label." Another reason to implement overages, Secrist said, is to accommodate variability related to the manufacturing process. "Each manufacturing process has a degree of variability," he explained. "If you're making a capsule … [and] you say there's supposed to be 300 mg in that capsule—if you set the target weight at 300 [mg], your encapsulation machine might bury plus or minus 10% of that, so you also typically will put in an overage for manufacturing variability." Secrist pointed to a third reason for adding overages: "There's always some uncertainty in every analytical method. "As you're testing for that analyte in the fi nished product, you want to be sure that you meet your specifi cation. If your test result shows that you're out of spec—and again, because of that manufacturing variability and the testing invariability inherent in that method itself— you could see some fl uctuation. You may really have 330 [mg], but depending on your method, it might only show 295 mg, which would be below your label claim of 300 mg." How Much Is Enough? Determining how much overage to add to a product is no easy feat. A range of considerations can affect how much overage is suffi cient. "Dosage form is certainly important," Secrist said. "Is it a softgel, is it a tablet, is it a capsule, a powder, a liquid? The active ingredients can degrade at different The Intricacies of Overages for Efficacy, Compliance and Safety by Rachel Adams Contract Manufacturing: Efficacious Doses Determining how much overage to add to a product is no easy feat. A range of considerations can affect how much overage is sufficient. | At the end of shelf life, supplements are required to have at least 100% of the ingredient amounts listed on the product's label. | To meet regulatory and quality standards, manufacturers should intentionally add an overage of ingredients listed on the label. | FDA has not established maximum amounts of ingredients allowed in supplements, but products need to be safe. INSIDER's Take

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