Health claim

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".

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. Dietary supplements are regulated as a separate type of consumer item from food or over-the-counter drugs.

Objections by consumer advocates

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.[1] In their comments to the FDA, The Center for Science in the Public Interest (CSPI) urged FDA officials to address the incongruity between current dietary recommendation/nutritional standards and their definition, CSPI argued that the current definition is too ambiguous and sets a low health standard that allows processed foods with minimal and low nutritional value to use this definition to entice consumers into making poor health choices.[2] The CSPI claimed that the FDA's current guidance on this issue could be potentially misleading and could incline customers to consume unhealthy foods without making informed decisions. CSPI and their research suggested that a new standard and more adequate definition should make it more difficult for processed food brands to obtain and misuse the “healthy” food label, ultimately giving consumers a better ability to make informed decisions based on the nutritional and health quality of the food they consume as opposed to relatively unsubstantiated claims.[2]

In addition to using the “healthy” food label to draw customers to low nutrition foods, food marketers have used a variety of “low content,” like low fat, low calorie, etc. claims to assuage consumer's health concerns and to potentially mislead them. “Low content” claims are labels or other advertised claims that appear on packages and or in advertisements are used so that consumers perceive the products they buy as being healthier or more nutritious.[3] Misleading food health assertions of this nature are both widespread in food marketing and also not reflective of the actual nutritional or health quality of the food or beverage in question. These claims are not consistent among all food and beverage groups, although some of them do accurately represent the nutritional and or health benefits of a certain food or beverage, often this does not guarantee that all claims across all beverages and foods are reflective of actual nutrition. Additionally, even if a certain product is in fact low fat or any one of the different types of “low content” claims, consumers often focus on the claim and neglect other health considerations like added sugars, calories, and other unhealthy ingredients.[3]

The Food industry constantly confuses consumers. Some of the basic reasons why people are misled is because terms such as natural, non-GMO, trans-fat free, or kosher do not have consistent definitions for consumers to follow.[4] Without clear standards or definitions, these claims are not informative of the true nutritional content of the food in question. Non-GMO products are often mistaken for organic, just because it is certified as non-GMO. Conventionally raised crops like corn, canola, and soy may be certified non-GMO if they are grown without genetically engineered seeds. Many snack chips being sold in stores use non-GMO ingredients grown with chemical pesticides. Non-GMO does not mean certified non-GMO. Many food products and nutritional products claim to be non-GMO but do not provide certification of that status. Any company that self-proclaims its products to be non-GMO has to back it up with certification.[4] Trans-Fat Free does not mean the food is free from trans fats. In fact, in the U.S. alone, the FDA currently allows foods containing up to 0.5g of trans fats per serving to claim zero grams of trans fats per serving, which is completely misleading.[4]

Choosing one food item over another for reasons such as products claiming they are all natural or fat free do not always mean it is healthier. The FDA does not define “natural” but if labeled so, the food must not contain added colors, artificial flavors, or synthetic substances.[5] However, foods labeled natural can contain preservatives. Companies will argue that natural products that contain high fructose corn syrup are healthy because it comes from corn. No sugar added items are often bought but also not fully understood. Foods like fruit, milk, cereals, and vegetables naturally contain sugar. Although there may not have been added sugar, they still contain natural sugars. These sugar free products may contain added ingredients like maltodextrin, which is a carbohydrate.[5] Carbohydrates may be simple sugars or complex starches that can raise blood sugar. Just because “no sugar added” is labeled does not mean the product is calorie free or carbohydrate free which most consumers often misunderstand. Most consumers are ignorant about the actual nutritional content of their foods and heavily rely on the food labels and claims that are provided on packages. This over-reliance on a variety of different claims has many implications including uninformed customer purchases and over-consumption of unhealthy foods.[5]

FDA guidelines

According to the FDA, "Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition".[6] The FDA has guidelines for what is considered a misleading label,[7] 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.[8]

Labels must include what the food actually is, that means if the food is canned carrots the can must have Carrots on the label. If an official name for the food does not exist, then the label must give the consumer some idea of what the food contains. The FDA states the name should be a “statement of identity,” meaning the company cannot make up a new name for an already existing food. A product must be called an imitation if its nutritional values are significantly different than the original food. There are also rules for the size of the font and what to name food products.[7] With beverage brands advertising as juice, the beverage must have a high content of the fruit or vegetable in the juice. The name of the juice must be from its more prominent fruit or vegetable by volume.[7] For example, Coca-Cola tried to sell pomegranate juice which had only .3% pomegranate in it, so they had to change the label.[9] For a beverage to be called "juice", it must be 100% juice; if it is less than 100%, then it must be called a drink or beverage.[7]

Marketing and consumer perceptions

Many companies have started to use their packaging for food as a marketing tool. Words such as “healthy”, “low-fat”, and “natural” have contributed to what is called the health-halo effect, which is when consumers overestimate the healthfulness of an item based on claims on the packaging.[10] Food companies may incorporate whole grain and higher fiber levels into their products in order to advertise these advantages. However, there is no regulated amount of grain needed in a certain product to be able to advertise this benefit, and the product may not be as nutritious as advertised.[10]

Other studies have shown that marketing for food products has demonstrated an effect on consumers’ perceptions of purchase intent and flavor. One study in particular performed by Food and Brand Lab researchers at Cornell University looked at how an organic label affects consumers’ perceptions. The study concluded that the label claiming the product was “organic” altered perceptions in various ways. Consumers perceived these foods to have fewer calories and stated they were willing to pay up to 23.4% more for the product.[11] The taste was supposedly “lower in fat” for the organic products as opposed to the regular ones. Finally, the study concluded that people who do not regularly read nutrition labels and who do not regularly buy organic food products are the most susceptible to this example of the health-halo effect.[11]

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.[12]

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:

  • A: "There is significant scientific agreement for [the claim]."
  • B: "Although there is some scientific evidence supporting [the claim], the evidence is not conclusive."
  • C: "Some scientific evidence suggests [the claim]. However, the FDA has determined that this evidence is limited and not conclusive."
  • D: "Very limited and preliminary scientific research suggests [the claim]. The FDA concludes that there is little scientific evidence supporting this claim."

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.[13]

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.

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.[14]

An overview of current and future situations on health claims in the European Union including proposals, press releases and memos can be found on the European Commission website: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.

All approved EU health claims translated into various European language available on http://ec.europa.eu/nuhclaims/

References

  1. 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.
  2. The Center for Science In The Public Interest. (2017, April 26). “Healthy” Definition Should Steer Consumers to Fruits & Vegetables: CSPI. Retrieved from Center for Science in the Public Interest website:https://cspinet.org/news/%E2%80%9Chealthy%E2%80%9D-definition-should-steer-consumers-fruits-vegetables-cspi-20170426
  3. "Government intervention on food needed to safeguard children's health: Report". foodnavigator.com. Retrieved 2017-12-11.
  4. "The 13 Most Misleading Food Label Claims - Naked Food Magazine". Naked Food Magazine. 2015-07-09. Retrieved 2017-12-11.
  5. "Healthy or hype? 16 most misleading food labels". Retrieved 2017-12-11.
  6. "Claims That Can Be Made for Conventional Foods and Dietary Supplements". U.S. Food and Drug Administration. September 2003. Retrieved 7 November 2010.
  7. Office of Nutrition, Labeling, and Dietary Supplements (January 2013). "A Food Labeling Guide" (PDF). FDA.gov.CS1 maint: multiple names: authors list (link)
  8. Edmundo Garcia Jr. (9 March 2018). "Warning letter: Carol Bond Health Foods". US Food and Drug Administration. Retrieved 15 April 2018.
  9. "POM Wonderful v. The Coca Cola Company, No. 12-761". ScotusBlog. February 22, 2013. Retrieved November 23, 2017.
  10. Brown, R. (2016, February 4). Why Food Labels Are So Misleading. Retrieved from Next Avenue website: http://www.nextavenue.org/why-food-labels-are-so-misleading/
  11. Cornell Food & Brand Lab. (2013, April 1). Organic labels bias consumers perceptions through the 'health halo effect'. ScienceDaily. Retrieved December 11, 2017 from www.sciencedaily.com/releases/2013/04/130401121506.htm
  12. "21 Code of Federal Regulations § 101.14 Health claims: general requirements". US Food and Drug Administration. 1 April 2015. Retrieved 15 January 2016.
  13. "Nutrition and health claims". European Food Safety Authority. 2017. Retrieved 15 April 2018.
  14. 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). "SpringerLink Journal Articles - European Journal of Nutrition - Passclaim: Consensus on Criteria". European Journal of Nutrition. 44 (1): i5–i30. doi:10.1007/s00394-005-1104-3. PMID 15933809.
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