New FDA Food Packaging Labels To Impact Medical Nutrition Market


Date : Oct 06, 2017 Author : PMR Editorial Staff Category : Healthcare

Experts caution that new regulations may compel manufacturers to change vitamin content in foods

The regulations necessitating food manufacturers to provide nutritional info on their product packages were laid down by the U.S. Food and Drug Administration with the passage of the Nutrition Labeling and Education Act in 1990. The regulations pertain to conventional dietary supplements and packaged foods and are meant to help consumers make healthy dietary choices. Labels display nutritional information in the form of Daily Value percentage in a single serving of the food product. The ‘per serving’ size depends on the food typically consumed by one person in one sitting – also known as Reference Amount Customarily Consumed. The DV percentage is a reflection of the proportion of recommended daily intake for a particular mineral or vitamin contained in one serving of the food or medical nutrition supplement.

Just over a year ago, the FDA introduced new labelling guidelines that change the DV of many vitamins and units of measurement for several others. In addition to this, the RACC was increased for certain food categories that would reflect new data about consumption patterns and scientific understandings of the connection between health and diet conditions such as heart disease and obesity. The changes are expected to become enforceable from July 26, 2018, but the FDA has already made clear that these initial compliance deadlines will be extended.

A few of the proposed changes are –

  • RDI values have been decreased for 6 minerals and 8 vitamins (Vitamin A, Vitamin B, Vitamin E, selenium, zinc, chloride, copper, chromium, and molybdenum)
  • RDI values have increased for 5 minerals and 3 vitamins (Vitamin C, Vitamin D, Calcium, Vitamin K, Synthetic Vitamin E, potassium, manganese, magnesium, and phosphorus)
  • The largest increase affected Vitamin D which rose by 100%
  • Nutrient content unit measures were changed from International Units to less understood units of measure for folic acid, Vitamin A, Vitamin D, and Vitamin E
  • RACCs were adjusted to increase serving size in a number of food categories

In a recent study published in the Journal of Nutrition, researchers analyzed the FDA regulations to identify any potential impact that these changes have on products sold in the advanced medical nutrition market. The authors were particularly concerned that these new norms would push manufacturers of fortified or enriched supplements and foods to alter their nutrition content and reformulate the products. The study results suggest that there could certainly be a potential response by manufacturers that impacts the nutrition density of products sold in the medical nutrition market. 

The following concerns were noted by researchers –

  • RDI changes affect the nutrient quantity needed to maintain attractive packaging nutritional claims in the advanced medical nutrition market
  • In situations where RDI has reduced, food products will show a higher percentage DV even if the nutritional content per serving has not actually changed
  • Manufacturers might respond to decreased RDI’s by reducing nutrient content in their products to maintain an identical DV percentage that was present before the new regulations came into force
  • RACC or serving size increases may well allow manufacturers to boast of higher percentage DV values even without any substantial change in food nutritional density
  • With serving size increases, manufacturers can potentially reduce the product vitamin and mineral concentrations and still ensure a similar percentage DV as before

The study authors note that the advanced medical nutrition market plays a critical role in ensuring adequate public nutrition. Nutrient product density reductions can significantly impact consumer health especially in vulnerable groups where nutritional intake is more challenging. Experts recommend that the impact of regulatory changes on public health and food quality be closely monitored for the foreseeable future. 


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