Industry Facts: Using the Qualified Health Claim in Promotional Marketing

On October 6, 2006, the US Food and Drug Administration (FDA) ruled that canola oil is eligible to bear a qualified health claim (QHC) on its ability to reduce the risk of coronary heart disease due to its unsaturated fat content. See wording approved by the FDA.

Use of the QHC outside the parameters set by FDA may result in regulatory enforcement action. To guide the industry, the US Canola Association prepared these facts.

If you have any question about use of the QHC, consult your regulatory counsel.

Eligibility for the QHC
Promotional use of the QHC

Timing

Related claims

ELIGIBILITY FOR THE QHC

What is "canola oil" for purposes of the QHC?

Canola oil, also known as low erucic acid rapeseed oil, is the fully refined, bleached, and deodorized edible oil obtained from certain varieties of Brassica Napus or B. Campestris of the family Cruciferae. For special types of canola oil (e.g., high stability, cold-pressed, expeller-pressed), you should discuss with your regulatory counsel whether the product meets this definition of canola oil and is eligible to bear the QHC.

What foods may use the QHC?

Use of the QHC is restricted to five specific food types:

  • "Canola oil," i.e., products that are essentially pure canola oil and are labeled as such;
  • "Vegetable oil spreads," i.e., margarine and margarine-like products;
  • "Dressings for salads," i.e., salad dressings;
  • "Shortenings," i.e., vegetable oil shortenings; and
  • "Canola oil-containing foods," i.e., all other foods, such as sauces and baked goods.

Other types of foods, including combination foods (e.g., main dish products, meal products) and dietary supplements, are not eligible for the QHC, even if formulated with canola oil.

How much canola oil must be present in a food to be eligible for the QHC? 

All eligible foods must contain at least 4.75 grams (g) of canola oil per "reference amount customarily consumed" (RACC).

What RACC applies to our company's product(s)?

RACCs are derived from consumption data and reflect the amount of a food typically consumed per eating occasion. FDA's RACCs for a number of food product categories are codified at 21 C.F.R. § 101.12(b)(Table 2). The following RACCs are relevant to the QHC:

  • Canola oil: 1 tablespoon (tbsp)
  • Vegetable oil spreads: 1 tbsp
  • Dressings for salads: 30 g
  • Shortenings: 1 tbsp
  • Canola oil-containing foods:
    • Snacks: 30 g
    • Crackers (non-snack varieties): 15 g
    • Major entrée sauces (e.g., pasta sauce): 125 g
    • Others: See § 101.12(b)(Table 2) for applicable product category and RACC

The applicable RACC is used in determining whether a food meets certain eligibility criteria for the QHC, including the 4.75 g of canola oil and other requirements noted below:

  • "Low saturated fat"
  • "Low cholesterol"
  • Disqualifying level for sodium
  • 10% minimum nutrient content requirement for vegetable oil spreads
  • Disclosure level for total fat (triggering the need for a statement accompanying the QHC on vegetable oil spreads, dressings for salads, shortenings, and canola oil-containing foods that exceed the level)

The applicable RACC is not necessarily the same as the Serving Size declared in your product's Nutrition Facts (but approximates it).

What other eligibility requirements apply? 

All eligible foods must:

  • Contain 1 g or less of saturated fatty acids per RACC and not more than 15% of calories from saturated fatty acids (i.e., qualify as "low saturated fat");
  • Contain 20 milligrams (mg) or less cholesterol per RACC and, if the applicable RACC is 30 g or 2 tbsp or less (such as for canola oil, vegetable oil spreads, dressings for salads, shortenings, and some canola-oil containing foods), also per 50 g of product (i.e., qualify as "low cholesterol"); and
  • Contains no more than 480 mg of sodium per RACC, per labeled Serving Size, and, if the applicable RACC is 30 g or 2 tbsp or less (such as for canola oil, vegetable oil spreads, dressings for salads, shortenings, and some canola-oil containing foods), also per 50 g of product (i.e., not exceed the disqualifying level for sodium).


Does any additional eligibility requirement apply to specific food types?

Yes. In addition to the other eligibility requirements, vegetable oil spreads and canola oil-containing foods (but not canola oil, dressings for salads, or shortenings) must contain, prior to any fortification, at least 10% of the Daily Value for vitamin A (i.e., at least 500 International Units), vitamin C (i.e., at least 6 mg), calcium (i.e., at least 100 mg), iron (i.e., at least 1.8 mg), protein (i.e., at least 5 g, protein digestibility-corrected amino acid score basis), or dietary fiber (i.e., at least 2.5 g) per RACC.

Does canola oil per se meet each of these eligibility requirements?

Yes. Any pure canola oil product may use the QHC. In contrast, the eligibility of any particular vegetable oil spread, dressing for salad, shortening, or canola oil-containing food to use the QHC should be determined on a case-by-case basis.

PROMOTIONAL USE OF THE QHC

Where may the QHC be used? 

All eligible foods may use the QHC on product labels, in labelling (e.g., hang tags and point-of-purchase brochures, counter cards, signs or video), in advertising (both print and broadcast), and on websites.

Is our company website labelling or advertising? 

It depends. If an eligible food's label or labelling cites the website, or if the food may be purchased directly from the website, FDA may regulate the website as labelling. Otherwise, the website typically will be regulated as advertising.

EXPRESSING THE QHC

What QHC did FDA authorize? 

FDA authorized use of the following QHC language:

Limited and not conclusive scientific evidence suggests that eating about 1½ tablespoons (19 grams) of canola oil daily may reduce the risk of coronary heart disease due to the unsaturated fat content in canola oil. To achieve this possible benefit, canola oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of canola oil.

To be safe, when expressing the full QHC in writing, use this exact language (of course substituting the actual number of grams of canola oil in a product Serving Size for "[x]").

Must any other statement accompany the QHC?

Sometimes, but never for a canola oil product per se. If a vegetable oil spread, dressing for salads, shortening, or canola oil-containing food contains more than 13 g of total fat per RACC, per labelled Serving Size, or, if the applicable RACC is 30 g or 2 tbsp or less (such as for vegetable oil spreads, dressings for salads, shortenings, and some canola-oil containing foods), per 50 g of product, then the QHC must be accompanied by the statement: See nutrition information for total fat content.

How should this total fat disclosure statement be presented? 

The disclosure statement should appear immediately adjacent to, and directly beneath, the QHC, with no intervening material, in the same type size, typeface, and contrast as the QHC itself. The disclosure statement must accompany the QHC on labels and in labelling, but its use is optional in advertising.

May an abbreviated expression of the claim be used?

Not exactly. On labels and in labelling, the principal display panel may bear a "reference statement" - See back panel for information about the relationship between unsaturated fatty acids from canola oil and coronary heart disease - directing consumers to the label/labelling panel where the full QHC is expressed. However, the full QHC must appear somewhere on the label or in the labelling.

What about the use of symbols, such as a heart? 

A health symbol, such as a heart, may be used, provided that it is immediately accompanied by the QHC or, if on a label or in labelling, by the reference statement. However, the QHC need not appear next to symbols that do not connote health, like a canola flower.

TIMING

When may our company begin using the QHC for eligible food products?

Immediately. FDA's exercise of enforcement discretion relative to eligible foods making the QHC in accordance with its letter began on October 6, 2006.

Will authority to use the QHC expire?

The QHC may be used indefinitely unless and until FDA withdraws or modifies the current authority. Absent some significant change in the scientific underpinnings for the QHC, this seems unlikely.

RELATED CLAIMS

What requirements apply to claiming that an individual food (i.e., not a main dish product or a meal product) is "low saturated fat"?

An individual food product may bear the claim, "low in saturated fat," "low saturated fat," "contains a small amount of saturated fat," "low source of saturated fat," or "a little saturated fat," provided that:

  • The food contains 1 g or less of saturated fatty acids per RACC and not more than 15 percent of calories from saturated fatty acids;
  • If a food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labelled to clearly refer to all foods of its type and not merely to the particular brand to which the claim attaches;
  • The level of total fat in the food is disclosed in immediate proximity to the claim, unless the food contains 3 g or less of total fat per RACC;
  • The level of cholesterol in the food is disclosed in immediate proximity to the claim, unless the food contains less than 2 mg of cholesterol per RACC; and
  • If the food contains more than 13 g of total fat per RACC, per labelled Serving Size, or, if the applicable RACC is 30 g or 2 tbsp or less (such as for canola oil, vegetable oil spreads, dressings for salads, shortenings, and some canola-oil containing foods), per 50 g of product, then the claim must be accompanied by a reference statement directing consumers to the product's Nutrition Facts.

Thus, a "low saturated fat" claim and accompanying information on the label of a canola oil product would declare, for example:

Canola Oil
A Low Saturated Fat Food
Contains 14 g of fat per serving
See nutrition information for fat content

FDA's regulations prescribe type size and other requirements for these items of information.

How may our company promote the healthful trans fat content of its food products?

FDA has not yet formally defined nutrient content claims fortransfat. This being the case, use of any unquantified claim (e.g., "transfat free") that characterizes thetransfat content of a food may subject it to risk of enforcement action. However, a quantified claim - 0 gtransfat per serving - for example, may be used.

May our company claim simply that its canola oil product is "cholesterol free"? 

Not exactly. A pure canola oil qualifies as "cholesterol free" under FDA's nutrient content claim definition because it:

  • Contains less than 2 mg of cholesterol per 1 tbsp RACC and per labelled serving; and
  • Contains 2 g or less of saturated fatty acids per RACC.

However, inasmuch as canola oil contains its healthy cholesterol level without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, the claim must be expressed so as to disclose that cholesterol is not usually present in the food. Moreover, because canola oil contains more than 13 g of total fat per RACC, the claim must be immediately accompanied by disclosure of the level of total fat in a Serving Size, and by a reference statement directing consumers to the product's Nutrition Facts. Thus, a cholesterol claim and accompanying information on the label of a canola oil product would declare, for example:

Canola Oil
A Cholesterol Free Food
Contains 14 g of fat per serving
See nutrition information for fat content

FDA's regulations prescribe type size and other requirements for these items of information. Also, certain prescribed synonyms may be used instead of "cholesterol free," including "free of cholesterol," "zero cholesterol," "without cholesterol," "no cholesterol," "trivial source of cholesterol," "negligible source of cholesterol" or "dietarily insignificant source of cholesterol."

Prepared by Olsson, Frank and Weeda, P.C., Attorneys at Law, Washington, D.C.
Tel: (202) 789-1212   www.ofwlaw.com

U.S. Canola Association 600 Pennsylvania Avenue SE, Suite 320 Washington, DC 20003
Tel: 202-969-8113 www.uscanola.com