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Health Claims and Regulatory Requirements

Over 200 clinical studies support the efficacy of plant sterols and stanols in lowering LDL cholesterol by as much as 10%.1,2 The evidence is strong enough that many countries have developed approved health claims to be used on fortified foods and dietary supplements about the benefits of sterols and stanols. Additionally, many major health organizations globally have recommended using sterols and stanols for cholesterol management, in turn reducing the global burden of heart disease.

Below are the approved health claims for various countries and a summary of the recommendations made by global health organizations.

United States- Food and Drug Administration (FDA)

2010 Proposed Rule: Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease (PDF download)

Two approved claims
  1. Foods containing at least 0.5 g per serving of phytosterols eaten with meals or snacks for a daily total intake of 2 g as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies __ g of phytosterols.
  2. Diets low in saturated fat and cholesterol that include 2 g per day of phytosterols eaten with meals or snacks may reduce the risk of heart disease. A serving of [name of food] supplies __g of phytosterols.

Food categories and use levels must be consistent with GRAS status of specific phytosterol ingredients and comply with any other nutrient content requirements of the claim, as provided in the original regulatory documentation.

History of claims and additional stipulations can be found:

2012: Federal Register Notice (2012): 2012-3940.pdf (govinfo.gov)

 

European Union- European Food and Safety Authority (EFSA)

Functional health claim

“Plant sterols/stanols contribute to the maintenance of normal blood cholesterol levels.”

  • Must recommend a beneficial daily intake of at least 0.8 g plant sterols/stanols.

Reference: EUR-Lex – 02012R0432-20240819 – EN – EUR-Lex (europa.eu)

 

Risk reduction claim

“Plant sterols have been shown to lower/reduce blood cholesterol. Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.”

  • Must recommend a beneficial daily intake of 1.5-3g plant sterols/stanols
  • Only authorized in yellow fat spreads, dairy products, mayonnaise, and salad dressings
  • Reference to the magnitude of the effect is dependent on the amount of sterols/stanols.
    • 7% to 10% reduction in cholesterol for foods that provide a daily intake of 1.5-2.4g plant sterols/stanols in 2 to 3 weeks
    • 10% to 12.5% for foods that provide a daily intake of 2.5-3g plant sterols/stanols in 2 to 3 weeks

Reference: EUR-Lex – 02009R0983-20140711 – EN – EUR-Lex (europa.eu)

Additional information

 

Canada - Health Canada

Approved Claims
  1. “[serving size from Nutrition Facts table in metric and common household measures] of [naming the product] provides X% of the daily amount* of plant sterols shown to help reduce/lower cholesterol in adults.”
    • Daily amount is 2 grams
  2. Two additional statements that could be used in combination or alone, adjacent to the primary statement, without any intervening printed, written, or graphic material:
    • “Plant sterols help reduce [or help lower] cholesterol.”
    • “High cholesterol is a risk factor for heart disease.”
The foods that can contain added phytosterols include:
  • B spreads
  • Mayonnaise
  • Margarine
  • Calorie-reduced margarine
  • Salad dressing
  • Yogurt and yogurt drinks
  • Vegetable and fruit juices
Additional information

Plant sterols in foods
Notice of safety assessment (Archived)
Plant sterols and blood cholesterol lowering
General Qs and As on Plant Sterols

Australia/New Zealand - Food Standards Australia New Zealand (FSANZ)

Approved claims

  1. When eaten at the recommended amount, between 2 and 3 grams a day, plant sterols can reduce low-density lipoprotein (LDL) cholesterol levels in our blood.
  2. Eating more than 3 grams per day does not reduce your LDL cholesterol any further.

The Food Standards Code permits the use of plant sterols in margarine, low fat milks, low fat yogurts and breakfast cereals, lower fat cheese, and processed cheese.

Additional information

Plant sterols
FSANZ Schedule 25: Permitted Novel Foods

Summary of Recommendations by Major Global Health Organizations

Organization Recommendation
American Heart Association (AHA) Includes the National Lipid Association’s goals for optimizing LDL-C and non-HDL-C To increase intake of PS to 2g/day.3
National Cholesterol Education Program (NCEP) – Adult Treatment Panel III (ATP III) The ATP III guidelines suggest the use of plant sterols as part of a therapeutic diet to lower LDL cholesterol levels in individuals with elevated cholesterol.4
National Institute for Health and Care Excellence (NICE) – UK NICE guidelines suggest that healthcare professionals consider offering plant sterol or stanol supplements as an option for individuals with high cholesterol who do not achieve their target LDL cholesterol levels with dietary and lifestyle changes alone.5
World Health Organization (WHO) WHO does not provide specific recommendations for phytosterols, they emphasize the importance of a healthy diet and lifestyle for the prevention and management of cardiovascular diseases, and phytosterols can be a part of such a diet.6

References

  1. Abumweis SS, Barake R, Jones PJ. Plant sterols/stanols as cholesterol lowering agents: A meta-analysis of randomized controlled trials. Food & nutrition research. 2008;52doi:10.3402/fnr.v52i0.1811
  2. Katan MB, Grundy SM, Jones P, Law M, Miettinen T, Paoletti R. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clinic proceedings. Aug 2003;78(8):965-78. doi:10.4065/78.8.965
  3. Jacobson TA, Maki KC, Orringer CE, et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J Clin Lipidol. Nov-Dec 2015;9(6 Suppl):S1-122.e1. doi:10.1016/j.jacl.2015.09.002
  4. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. Dec 17 2002;106(25):3143-421.
  5. Health NIf, Excellence C. Familial Hypercholesterolaemia: Identification and Management of Familial Hypercholesterolaemia. NICE; 2008.
  6. Who J, Consultation FE. Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916(i–viii):1-149.