New Regulations for Dietary Supplement Labels

By Curtis Walcker, M.S.
June 24, 2015

Will Your Supplement Facts Panels Require Changes Soon?

New RegulationsThe final rules resulting from the FDA proposed changes to nutrition labels, including the Supplement Facts panel, will become effective 60 days after publication in the Federal Register. January 1, 2018 will be the uniform compliance date, provided that the regulations are issued as expected in 2016.

Although this timeline sounds long, it really is not. Labels will need to be evaluated for needing changes. Current labels will need to be depleted. Changed labels will need new design work and reprinting. Although the changes that will occur can only be speculated on right now based on the proposals, doing an early self-audit can give you a rough estimate of how extensive your changes may be.

Here are five questions you should be asking right now. If you can answer “yes” to one or more for a label, it is possible that it will require changes.

  1. Do you currently declare any of the following?
    • Calories (significant dietary amount)
    • Calories from Fat
    • Total Carbohydrate
    • Other Carbohydrate
    • Sodium
    • Potassium
    • Dietary Fiber
    • Vitamin A
    • Vitamin C
    • Calcium
    • Vitamin D
    • Vitamin E
    • Vitamin K
    • Thiamin
    • Riboflavin
    • Niacin
    • Vitamin B6
    • Folic acid, folate, or folacin
    • Vitamin B12
    • Biotin
    • Pantothenic acid
    • Phosphorus
    • Magnesium
    • Zinc
    • Selenium
    • Copper
    • Manganese
    • Chromium
    • Molybdenum
    • Chloride
    • Choline
  2. Does your product contain sugars that are either added as ingredients during processing or are finished products; this includes sugars (free, mono-, and disaccharides, syrups, naturally-occurring and concentrated sugars isolated from a whole food (e.g., fruit juice concentrates)), or other caloric sweeteners?
  3. Does your label currently not declare vitamin D or potassium, but contain more than 0.4 mcg (16 IU) vitamin D or 5 mg potassium per serving?
  4. Does your label include nutrition information or recommendations for subpopulations such as infants, pregnant or nursing women, or children?
  5. Are you using nutrient content claims or health claims?

Answering “yes” to question #1 will probably result in the most label changes. There is also a possibility that the footnotes and/or formatting could see revisions that could produce much more sweeping changes.

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