The food and dietary supplement industry operates under a complex web of regulations designed to protect consumers and ensure product safety and accurate advertising. In the United States, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are the primary agencies responsible for overseeing this industry. Any business operating in the food and dietary supplements industry in the United States has to comply with the rules and regulations of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Dietary supplements come under similar regulations as food.
The Roles of the FDA and FTC
The FDA primarily regulates product labeling, while the FTC oversees advertising. This division of responsibilities is formalized through a liaison agreement between the two agencies. The FDA is responsible for claims on product labeling, while the FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. The FTC Advertising Law is designed to “prohibit unfair or deceptive acts or practices in commerce” (Section 5) and “prohibits false ads” (Section 12), this is inclusive, but not limited to, dietary supplements. Both agencies share the common goal of protecting consumers by ensuring that products are safe, effective, and accurately marketed.
FDA Regulations: Ensuring Safety and Informed Choices
The FDA's regulatory authority stems from the Federal Food, Drug, and Cosmetic Act (FDCA) and the Dietary Supplement Health and Education Act (DSHEA) of 1994. The DSHEA also requires that no dietary supplement be adulterated as this can cause an unreasonable risk of illness. These laws grant the FDA the power to set standards for dietary supplement manufacturing, labeling, and safety. In order to keep consumers safe by making informed decisions about a product, the FDA has placed stringent labeling regulations on dietary supplements.
Labeling Requirements
Dietary supplement labels must provide consumers with essential information. It must include the manufacturer’s name and place of business, list all ingredients, and state the net contents of the product. The Dietary Supplement’s current GMP (cGMP) rule requires producers to establish good manufacturing practices that will ensure the quality of the product and that it is packaged correctly. The FDA has approved a couple of ways in which manufacturers can notify consumers of any potential allergens in the product. The most common option is to place a form either in or on the packaging. A further option that simplifies the process for rebate sponsors and consumers is to add an easy-to-access webpage URL or a QR code. This type of rebate program is the best way to obtain information about a customer that can be stored in a database for future use.
Health Claims and FDA Authorization
Dietary supplements cannot claim they can treat, prevent, or cure any disease or condition. However, FDA authorization is necessary when health claims are made. The FDA must review any scientific evidence before approving the use of the product in such cases.
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Good Manufacturing Practices (GMP)
The dietary supplement current good manufacturing practice (CGMP) rule (21 CFR Part 111) requires persons who manufacture, package, label, or hold a finished dietary supplement to establish and follow CGMPs to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. The regulations for dietary supplements require manufacturers ensure the identity, purity, quality, strength and composition of both their ingredients and their finished dietary supplements. include the 100% identity testing requirement for incoming raw materials and finished product testing to ensure identity, purity, quality, strength and composition of dietary supplements.
Adverse Event Reporting
The manufacturer, packer, or distributor whose name and address appear on the label of a dietary supplement marketed in the United States is required to submit to FDA within 14 days all serious adverse events reported to the company as being associated with use of the dietary supplement in the United States.
FDA Food Safety Modernization Act (FSMA)
Most aspects of the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, apply to dietary supplements and their ingredients. The law enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.
Claims on Food and Dietary Supplement Labels
Claims that can be used on food and dietary supplement labels fall into four categories: nutrient content claims, nutrient deficiency claims, structure/function claims and health claims. The responsibility for ensuring the validity of these claims rests with the manufacturer.
FTC Regulations: Truth in Advertising
The FTC's role is to ensure that advertising for food and dietary supplements is truthful and not misleading. The Federal Trade Commission (FTC) has issued its Health Products Compliance Guidance (the Health Products Guidance), updating and replacing the Dietary Supplements: An Advertising Guide for Industry from 1998. The Health Products Guidance “draws on” issues raised in more than 200 FTC cases since 1998 involving false or misleading claims about the benefits or safety of health-related products and reinforces that FTC continues to scrutinize advertising of this category. While the 1998 Guide was applied widely as a best practice, FTC’s scope of coverage under the new Guidance clearly indicates it intends to reach broadly across advertising mediums, reflecting the complex realities of today’s marketplace.
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Reasonable Basis for Claims
Marketers must have a “reasonable basis” for their claims before disseminating them, and advertisements referring to a specific level of support must possess at least that level of support. While the “reasonable basis” may vary depending on the claim and context of the ad, the Guidance explains that several factors determine the appropriate amount and type of substantiation required including: the type of product, the type of claim, the benefits of a truthful claim and feasibility of developing substantiation, the consequences of a false claim, and the amount of substantiation experts in the field believe to be reasonable.
For claims about the efficacy or safety of health-related products, the factors identified above make up FTC’s “competent and reliable scientific evidence” standard. Importantly, the Guidance further reiterates that “as a general matter” for health-related benefit claims, randomized controlled human clinical testing (RCT) is required to meet the competent and reliable scientific substantiation standard. RCTs are considered by FTC to be “the most reliable form of evidence” and the Guidance notes that they are typically required by experts to substantiate health benefit claims. Importantly, FTC acknowledges that in “limited cases where: 1) it is considered an acceptable substitute for RCTs by experts in the field; and 2) RCTs aren’t otherwise feasible,” the FTC will accept high-quality epidemiological evidence to substantiate a health-related claim.
Unacceptable Evidence
Further, according to the Guidance, certain evidence - standing alone - is not sufficient to substantiate claims about the effects of a health product. This includes “anecdotal evidence about the individual experiences of consumers” (such as consumer surveys), healthcare practitioner observations about the effect of a health product on patients, and public health recommendations and advisories from a medical organization.
Testimonials and Endorsements
The Guidance emphasizes that advertisers must have appropriate scientific evidence to support express and implied claims that a product is effective and will work for buyers, whether the claims are made directly or through consumer testimonials or expert endorsements. Thus, advertisers should not make claims through consumer testimonials or expert endorsements that would be deceptive or couldn’t be substantiated if the advertiser made them directly. As to testimonials, attempts to disclaim results with statements like “results not typical” are not sufficient to cure deception.
Qualifying Claims
At the same time, the FTC explains that an advertisement may describe the traditional or historic use of a product if it carefully qualifies the claim to avoid any misleading implications about the product’s efficacy or health benefits. An ad may be misleading if it fails to disclose qualifying information that is material in the context of the claims or customary use of the product. For health-related claims, this includes disclosure of significant limitations on advertised health benefits and significant safety risks.
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Vague qualifiers stating that a product “may” have a claimed benefit or “helps” to achieve a claimed benefit, are inadequate to qualify the claimed benefit. The “ultimate test” of a disclosure is consumers’ net impression of the ad with the disclosure. If a “significant minority of consumers” are misled by the ad, despite the disclosure, then the disclosure is not sufficient. If it is not possible to make an effective disclosure, the claim should either be modified so that a disclosure is not necessary, or the claim should be removed.
FTC and FDA Shared Jurisdiction
As with the prior dietary supplements Advertising Guide, the Guidance also discusses the FTC and Food and Drug Administration’s (FDA) shared jurisdiction over the marketing of health-related products, including dietary supplements, foods, drugs, and devices. It emphasizes that the agencies work closely together to ensure that enforcement efforts are consistent, and notes that both agencies have authority to take action against marketers making deceptive labeling claims.
DSHEA Disclaimer and FTC Act
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requiring a two-part disclaimer on dietary supplement product labels stating that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent any disease, “has no effect on the FTC Act.” Thus, the DSHEA disclaimer is not required in other forms of advertising.
FTC Presumption on Health Claims
Unlike the FDA, the FTC does not pre-approve health claims. However, the FTC presumes that health claims that meet FDA’s “significant scientific agreement” standard are substantiated. Advertisers should be careful not to mischaracterize the extent of FDA approval, review, or authorization of a claim or product, including the science supporting a particular claim.
Notification for Structure/Function Claims
Unlike the FDA, the FTC does not require notification for structure/function claims.
Navigating Nutrient Content Claims
The NLEA mandated that FDA undertake a consumer education effort to educate consumers about the new food label and the importance of diet to health. Therefore, in keeping with its recently expanded and unique jurisdictional mandate, the requirements set forth in FDA's regulations have a broader purpose than preventing false and misleading claims in food labeling.
The NLEA applies only to labeling and did not change the FTC's statutory authority to prohibit deceptive acts or practices under Section 5 of the FTC Act. Nevertheless, in light of the comprehensive regulatory scheme established for food labeling claims by the NLEA, the Commission is issuing this statement to clarify how its own authority relates to issues raised by FDA's food labeling regulations.
The Commission recognizes the importance of consistent treatment of nutrient content and health claims in food advertising and labeling and seeks to harmonize its advertising enforcement program with FDA's food labeling regulations to the fullest extent possible under the statutory authority of the FTC Act. The Commission also recognizes the scientific expertise of FDA in this area. The Commission has traditionally accorded great weight to FDA's scientific determinations in matters of nutrition and health and will continue to do so. In addition, as a general matter, it is unlikely that the Commission will take action under Sections 5 and 12 of the FTC Act regarding nutrient content and health claims if they comply with FDA's regulations.
Claims made in food advertising may raise issues addressed in more than one section of this statement. Advertisers, therefore, should comply with all relevant provisions of the statement and not simply the provision that seems most directly applicable.
In issuing this statement, the Commission recognizes that the FDA intends its regulatory approach to be dynamic, designed to respond to changes in science and consumer understanding of nutrition and diet-disease issues. Therefore, while the Commission's purpose in issuing this statement is to provide guidance on how it will enforce Sections 5 and 12 in the food advertising area, the statement is not intended to provide a comprehensive analysis of how each of FDA's regulations relates to the Commission's enforcement policy. Instead, this statement focuses on the general issues that are likely to remain relevant to the Commission's regulation of food advertising over time, as specific provisions in the FDA regulations are amended.
Absolute and Comparative Nutrient Content Claims
As mandated by the NLEA, FDA's regulations define certain absolute and comparative terms that can be used to characterize the level of a nutrient in a food. "Absolute" terms (e.g., "low," "high," "lean") describe the amount of nutrient in one serving of a food. "Relative" or comparative terms (e.g., "less," "reduced," "more") compare the amount of a nutrient in one food with the amount of the same nutrient in another food. With very few exceptions, only these specific terms, and certain approved synonyms, may be used on food labels to characterize the level of a nutrient, although interested parties may petition FDA to authorize new nutrient content terms and synonyms.
Absolute Nutrient Content Claims
Prior to the finalization of FDA's regulations, there was no comprehensive set of standardized definitions for absolute terms such as "low" and "high" to describe the level of a nutrient in a food. Now that FDA has established a standard metric to describe the nutrient content of foods, the Commission will apply FDA's definitions for absolute nutrient content terms when those terms are used in the same context in advertising. In general, the Commission will use FDA's serving size or reference amounts customarily consumed, as set forth in FDA's regulations, in its analysis of a claim. If, however, an advertiser chooses to depict a non-standard serving size in an advertisement, the Commission will require the advertiser to meet the FDA's standard both for the reference amount customarily consumed and for the serving size depicted.
The Commission has previously indicated that where a claim is subject to the joint jurisdiction of the FTC and the FDA, it will accord significant deference to the FDA's standards. Consumer understanding will be improved if the agencies responsible for regulating the use of express or implied absolute nutrient content descriptors have consistent requirements for use of these terms. Multiple governmental definitions for the same terms would have the potential to mislead consumers. Similarly, the use in advertising of FDA-defined terms in a manner inconsistent with FDA's definitions is likely to mislead consumers.
Where FDA has not established any standard metric, such as "low" or "high," for a specific nutrient, the Commission will closely review claims in food advertising that characterize the level of that nutrient. The Commission has traditionally deferred to FDA's scientific and public health determinations, and will consult with FDA and other government and public health authorities regarding the significance of the nutrient for which such a claim is made.
Comparative Nutrient Content Claims
FDA's regulations also establish definitions for comparative terms that characterize the nutrient content of a labeled food relative to that of a comparison or "reference" food. These definitions require that a food bearing a comparative term meet specified minimum percentage differences in the relevant nutrient. For example, the regulations permit use of the terms "less" and "reduced" only where there is a minimum 25 percent difference in the relevant nutrient. In addition, comparative claims must disclose the reference food, the percentage difference in the nutrient between the labeled and reference food (e.g., "50 percent less fat than our regular cheese"), and quantitative information regarding the absolute amount of the nutrient in the labeled and reference foods (e.g., "fat reduced from 6 g. to 3 g. per serving").
Comparative nutrient content claims that comply with FDA's regulations will generally comply with Section 5. The Commission will scrutinize carefully comparative nutrient content claims that characterize nutrient differences in ways that do not comply with FDA's regulations. However, a comparative advertising claim that is accurately qualified to identify the nature of a nutrient difference and to eliminate misleading implications may comply with Section 5, even if the nutrient difference does not meet FDA's prescribed differences for purposes of labeling.
In examining comparative claims, several principles are likely to be applied by the Commission. First, comparative claims should make clear the basis for the comparison. Claims should identify the reference food to which the product is being compared to so that the appropriate comparison is clear to consumers. Second, consistent with the position it has taken on the use of descriptors, the Commission believes that advertisers using unqualified comparative terms must meet FDA's minimum percentage difference requirements for those claims. For example, if an ad represents that a food has "less fat than Brand X," without indicating the percentage or absolute difference in fat, the Commission will rely on FDA's 25% minimum difference requirement in determining whether the claim is deceptive.Third, comparative claims should not overstate the significance of a nutrient difference. For this reason, some comparative claims may need to be qualified in a manner sufficient to ensure that consumers are not misled regarding the significance of the nutrient difference. For example, a simple statement of percentage difference for a food that contains only a small amount of a nutrient, such as "our crackers have one-third less fat than Brand X," may suggest that the nutrient difference is greater.
The Rise of Influencer Marketing and Its Regulatory Challenges
Recent years have seen the rise of influencers marketing dietary supplements. These supplements, often created and marketed to stimulate weight loss, include “vitamins, essential minerals, protein, amino acids, and herbs.” Influencers’ foray into the realm of dietary supplements has had a significant impact on the marketing industry, as demonstrated by their enormous advertising revenue, with estimates that influencer marketing would reach “$10-20 billion in 2020, with close to 80% of brands participating.” With regard to the regulation of this industry, the federal government plays a role via both the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), which “both serve to protect consumers by ensuring safe, effective products and accurate marketing to consumers.” However, the regulatory environment for dietary supplements, which has been criticized as being inadequate in the face of hazards, has serious pitfalls when confronting promotion of these supplements by social media influencers.
Disclosure of Monetary Relationships
Under the FTC Act, the FTC requires the disclosure of a monetary relationship between a brand and the endorser in a manner that is “clear and conspicuous.” Yet, in an effort to create the illusion of a genuine endorsement, influencers frequently hide the disclosure-typically signified by “#ad” or a mention of “paid partnership”-deep within other hashtags, putting the disclosure after multiple pages or forgoing the disclosure entirely. This deception often goes unnoticed and may change how a consumer perceives the post, as the average consumer cannot differentiate content that is advertising from content that is not, opening the door to harmful deception.
Negligent Misrepresentation
Although there are no private rights of action under the FTC Act or DSHEA, common law offers a tool for consumers to reduce false and misleading claims in influencer marketing by holding individual influencers-and not the companies selling the products-liable for negligent misrepresentation. The first and third elements of the claim can be met simply by looking to the nature of influencer marketing: the influencer is the person supplying the false information in the advertisement, and advertisements are used to induce consumers to buy a product. Further strengthening this assessment, most brands provide influencers with substantial creative freedom, giving up significant control over what is said in the advertisement. Control is key in determining that the influencer-not the company-is the proper “defendant” who is actually supplying the false information. Hence, the control given to influencers over advertising may make establishing influencer liability for false or misleading claims easier, and doing so would not be without precedent.
Structure/Function Claims
Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.
Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity."
General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States.
These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
Structure/function claims may not explicitly or implicitly link the claimed effect of the nutrient or dietary ingredient to a disease or state of health leading to a disease. Structure/function claims for conventional foods focus on effects derived from nutritive value, while structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.
New Dietary Ingredients
A firm planning to market a dietary supplement that contains a new dietary ingredient, unless exempt, must submit to FDA, at least 75 days before the dietary ingredient is introduced into interstate commerce, information that is the basis on which it has concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. The term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States before October 15, 1994. Old ingredients (sometimes referred to as “grandfathered” ingredients) were marketed in the United States before that date and are generally considered safe unless the FDA demonstrates they are not.
Challenges and Future Directions
Despite the existing regulatory framework, challenges remain in ensuring the quality and safety of dietary supplements. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety.
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