Health claim

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A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".

Contents

Health claims are also made for over-the-counter drugs and prescription drugs, medical procedures, and medical devices, but these generally have a separate, much more stringent set of regulations.

Health claims in the United States

In the United States, health claims on nutrition facts labels are regulated by the U.S. Food and Drug Administration (FDA), while advertising is regulated by the Federal Trade Commission. [1] Dietary supplements are regulated as a separate type of consumer item from food or over-the-counter drugs.[ citation needed ]

Food

FDA guidelines

According to the FDA, "Authorized health claims in food labeling are claims that have been reviewed by FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition." [2] [3] An authorized health claim is limited to evidence for reducing the risk of a disease, and does not apply to the diagnosis, cure, mitigation, or treatment of disease. [3] It must be reviewed, evaluated, and publicly-announced by the FDA prior to use. [3]

Approval of a health claim by the FDA requires significant scientific agreement (SSA) among reputable scientists that the claim is based on publicly-available evidence that a relationship exists between an element and a disease. [2] [3] The SSA standard provides a high degree of confidence that the relationship between the element and the disease is valid. [2]

Based on scientific evidence, such claims may be used for marketing on foods or dietary supplements. [2] The authorized health claim must be written in a way that helps consumers understand the importance of including the element in their daily diet. [2]

The FDA has guidelines for what is considered a misleading label, [4] and also monitors and warns food manufacturers against labeling foods as having specific health effects when no evidence exists to support such statements, such as for one manufacturer in 2018. [5]

A qualified health claim is supported by some scientific evidence, but does not meet the significant scientific standard of evidence required for an authorized health claim. Qualified health claims must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim. [6]

Consumer advocacy

The use of the label “Healthy” on a variety of foods has been a particular issue for many food quality advocacy groups. In general, claims of health benefits for specific foodstuffs are not supported by scientific evidence and are not evaluated by national regulatory agencies. Additionally, research funded by manufacturers or marketers has been criticized to result in more favorable results than those from independently funded research. [7]

Dietary supplements

In the United States, these claims, usually referred to as "qualified health claims", are regulated by the Food and Drug Administration (FDA) in the public interest. [8]

The rule in place before 2003 required "significant scientific consensus" before a claim could be made, applying characterization of a hierarchy of degrees of certainty:

See the Wikipedia article on dietary supplements for a description of current FDA policy.

Health claims in Canada

Health claims in Europe

In the European Union, the European Food Safety Authority provides regulations on food labeling to address the quality of possible health foods. [9]

In the United Kingdom by law any health claim on food labels must be true and not misleading. Food producers may optionally use the (discontinued in 2010) Joint Health Claims Initiative to determine whether their claims are likely to be legally sustainable.[ citation needed ]

In early 2005 the European PASSCLAIM project (Process for the Assessment of Scientific Support for Claims on Foods), sponsored by the European Union and coordinated by ILSI-Europe (https://web.archive.org/web/20090822045739/http://europe.ilsi.org/), ended. The aim of this project was to develop criteria for the scientific substantiation of claims on foods. Several hundreds of scientists from academia, research institutes, government and industry have contributed to the project. All the resulting papers can be downloaded for free from http://www.ilsi.org/Europe/Pages/PASSCLAIM_Pubs.aspx. The final consensus paper, comprising the final set of criteria, has been published in June 2005 in the European Journal of Nutrition. [10]

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Dietary supplement</span> Product that provides additional source of nutrients

A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.

In the U.S. and Canada, the Reference Daily Intake (RDI) is used in nutrition labeling on food and dietary supplement products to indicate the daily intake level of a nutrient that is considered to be sufficient to meet the requirements of 97–98% of healthy individuals in every demographic in the United States. While developed for the US population, it has been adopted by other countries, though not universally.

<span class="mw-page-title-main">Nutraceutical</span> Class of nutritional product

A nutraceutical is a pharmaceutical alternative which claims physiological benefits. In the US, nutraceuticals are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act. The word "nutraceutical" is a portmanteau term, blending the words "nutrition" and "pharmaceutical".

<span class="mw-page-title-main">Cranberry juice</span> Liquid juice of the cranberry

Cranberry juice is the liquid juice of the cranberry – a fruit recognized for its bright red color, tart taste, and versatility for product manufacturing. Major cranberry products include cranberry juice, dried cranberry, cranberry sauce, frozen cranberry, cranberry powder, and dietary supplements containing cranberry extracts.

Chromium deficiency is described as the consequence of an insufficient dietary intake of the mineral chromium. Chromium was first proposed as an essential element for normal glucose metabolism in 1959, and was widely accepted as being such by the 1990s. Cases of deficiency were described in people who received all of their nutrition intravenously for long periods of time.

<span class="mw-page-title-main">Nutrition facts label</span> Table of nutrition facts on food labels

The nutrition facts label is a label required on most packaged food in many countries, showing what nutrients and other ingredients are in the food. Labels are usually based on official nutritional rating systems. Most countries also release overall nutrition guides for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods.

<span class="mw-page-title-main">Food policy</span> Area of public policy

Food policy is the area of public policy concerning how food is produced, processed, distributed, purchased, or provided. Food policies are designed to influence the operation of the food and agriculture system balanced with ensuring human health needs. This often includes decision-making around production and processing techniques, marketing, availability, utilization, and consumption of food, in the interest of meeting or furthering social objectives. Food policy can be promulgated on any level, from local to global, and by a government agency, business, or organization. Food policymakers engage in activities such as regulation of food-related industries, establishing eligibility standards for food assistance programs for the poor, ensuring safety of the food supply, food labeling, and even the qualifications of a product to be considered organic.

<span class="mw-page-title-main">Benecol</span> Brand of cholesterol-lowering food products

Benecol is a brand of cholesterol-lowering food products owned by the Finnish company Raisio Group, which owns the trademark.

The health freedom movement is a libertarian coalition that opposes regulation of health practices and advocates for increased access to "non-traditional" health care.

The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.

<span class="mw-page-title-main">Medical food</span>

Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015.

<span class="mw-page-title-main">Nutrition Labeling and Education Act of 1990</span> US law

The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.

<span class="mw-page-title-main">Regulation of food and dietary supplements by the U.S. Food and Drug Administration</span> Governmental regulation of food quality

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Canadian health claims by Health Canada, the department of the Government of Canada responsible for national health, has allowed five scientifically verified disease risk reduction claims to be used on food labels and on food advertising. Other countries, including the United States and Great Britain, have approved similar health claims on food labels.

<span class="mw-page-title-main">Food and Drug Administration Safety and Innovation Act</span> Piece of American regulatory legislation

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.

<span class="mw-page-title-main">Dietary Supplement Health and Education Act of 1994</span> 1994 statute of United States Federal legislation

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing of their health and medical claims.

Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.

<span class="mw-page-title-main">The Proxmire Amendment</span> US legislation related to dietary supplements

The Proxmire Amendments were a series of legislation that prohibits the Food and Drug Administration from monitoring and limiting the potency of vitamins and minerals found in dietary supplements. The Proxmire Amendment also made it so that food supplements could not be classified as drugs, making their sale possible without a prescription from a doctor. According to a study done, "dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogs, enzymes, and concentrates, metabolites, constituents, or extracts of these." They can be used by anyone wishing to purchase them as much or as little as they desire. Dietary supplements can be used to increase productivity, treating illness, helping mental health such as depression and anxiety, enhancing mental abilities, building muscle, or losing weight, among many other uses. William Proxmire, a Senator for Wisconsin, was instrumental in influencing the passing the Proxmire Amendment. The Proxmire Amendment is also known as The Rogers-Proxmire Amendment of 1976, and The Vitamins and Minerals Amendments. This amendment became section 411 of the Federal Food, Drug, and Cosmetic Act.

References

  1. ↑ "Labels 101". Labels Unwrapped | Learn How to Read Food Labels. Retrieved 2021-09-23.{{cite web}}: CS1 maint: url-status (link)
  2. 1 2 3 4 5 "Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard". U.S. Food and Drug Administration. 7 March 2022. Retrieved 20 December 2022.
  3. 1 2 3 4 "Questions and Answers on Health Claims in Food Labeling". US Food and Drug Administration. 13 December 2017. Retrieved 20 December 2022.
  4. ↑ Office of Nutrition, Labeling, and Dietary Supplements (January 2013). "A Food Labeling Guide" (PDF). FDA.gov.{{cite web}}: CS1 maint: multiple names: authors list (link)
  5. ↑ Edmundo Garcia Jr. (9 March 2018). "Warning letter: Carol Bond Health Foods". US Food and Drug Administration. Retrieved 15 April 2018.
  6. ↑ "Qualified health claim". US Food and Drug Administration. 7 March 2022. Retrieved 20 December 2022.
  7. ↑ Lenard I. Lesser; Cara B. Ebbeling; Merrill Goozner; David Wypij; David S. Ludwig (January 9, 2007). "Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles". PLOS Medicine. 4 (1): e5. doi:10.1371/journal.pmed.0040005. PMC   1764435 . PMID   17214504. Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health. Open Access logo PLoS transparent.svg
  8. ↑ "21 Code of Federal Regulations § 101.14 Health claims: general requirements". US Food and Drug Administration. 1 April 2015. Retrieved 15 January 2016.
  9. ↑ "Nutrition and health claims". European Food Safety Authority. 2017. Retrieved 15 April 2018.
  10. ↑ Verhagen, Hans; Tuijtelaars, Sandra; Rechkemmer, Gerhard; Pijls, Loek T. J.; Persin, Christoph; Müller, Detlef J. G.; Howlett, John; Cummings, John H.; Contor, Laura; Bellisle, France; Asp, Nils-Georg; Antoine, Jean-Michel; Aggett, Peter J. (June 2005). "Passclaim". European Journal of Nutrition. 44 (1): i5–i30. doi:10.1007/s00394-005-1104-3. PMID   15933809.
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