FDA Regulation on Labeling & Nutrition Format

Labeling Format:

A. Overall

1. The "Drug Facts" labeling is presented in all black type printed on a white color contrasting background.

B. Typeface and size

1. Drug Facts" is set in 9 point Helvetica Bold Italic, left justified.
2. The headings (e.g., "Directions") are set in 8 point Helvetica Bold Italic, left justified.
3. The subheadings (e.g., "Ask a doctor or pharmacist before use if you are") are set in 6 point Helvetica Bold, left justified.
4. The information is set in 6 point Helvetica Regular with 6.5 point leading, left justified.
5. The heading "Purpose" is right justified.
6. The bullet is a 5-point solid square.
7. Bulleted information may start on same line as headings (except for the "Warnings" heading) and subheadings, with 2 em spacing separating bullets, and need not be vertically aligned.

C. Barlines and hairlines

1. A 2.5-point horizontal barline extends to each end of the "Drug Facts" box (or similar enclosure), providing separation between each of the headings.
2. A 0.5-point horizontal hairline extends within 2 spaces on either side of the "Drug Facts" box (or similar enclosure), immediately following the title and immediately preceding the subheadings.

D. Box or Enclosure

1. All information is set off by color contrast. No barline is used.

Nutrition Format:

FDA Nutrition Label Font Sizes

All headings and nutrients that are not indented are required to be highlighted in bold or extra bold type. This includes Nutrition Facts, Serving Size, Amount per serving, % Daily Value, Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrate, and Protein.

Nutrition Facts

"Nutrition Facts" must be the largest text in the panel; (except for the numerical information for Calories) at least 16 point for Standard formats and 10 point for Tabular and Linear formats. For example, if you set your Calories font to 16 point, the Nutrition Facts heading must be 16 point or higher.

• At least 16 point font for Standard formats
• At least 10 point font for Tabular and Linear formats

Servings per container

• At least 10 point font for Standard formats
• At least 9 point font for Tabular and Linear formats

Servings size + Servings Size Amount

• At least 10 point font for Standard formats
• At least 9 point font for Tabular and Linear formats

The serving size amount must be right justified if adequate space is available. If the "Serving size" declaration does not fit in the allocated space a type size of no smaller than 8 point may be used on packages of any size.

Amount Per Serving

• At least 6 point font for all formats

Calories

• At least 16 point font for Standard formats
• At least 10 point font for Tabular and Linear formats

Numeric Calorie Value

• At least 22 point font for Standard formats
• At least 14 point font for Tabular and Linear formats

%DV Heading

• At least 6 point font for all formats

Nutrients and %DV Value

• At least 8 point font for all formats

Footnote

• At least 6 point font for all formats

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