Myers Detox Advertising Claims Compliance Protocol

            Thank you for participating in Myers Detox’s Affiliate Program. We look forward to working with you as we build a strong and vibrant brand. As an affiliate, you are expected, and contractually required, to comply with all advertising laws.  This Compliance Protocol will assist you in developing compliant advertising copy.  Any questions regarding this Protocol should be directed to [email protected].

Why is Advertising Compliance Important?

            Myers Detox must comply with the Food and Drug Administration (“FDA”) and the Federal Trade Commission’s (“FTC”) guidelines when promoting and selling its products and services. Similarly, any affiliate’s promotion of Myers Detox’s products or services must comply with FDA and FTC guidelines.  Failure to develop compliant advertising risks enforcement action by state and federal regulators, consumer class actions for false or misleading advertising claims, and ultimately tarnishes Myers Detox’s brand.  Myers Detox is devoted to building its brand and values its relationship with regulators and its reputation with consumers.  Our mutual success depends on developing compliant, but innovative and persuasive promotional materials.

            Myers Detox is a leader in the dietary supplement industry and therefore not a follower when it comes to developing advertising copy. Myers Detox strongly discourages affiliates from comparing Myers Detox’s products or advertisements to its competitors’ when developing promotional materials. Affiliates should rely on this Protocol alone when determining the bounds of permissible advertising claims.

FDA Compliance – Dos and Don’ts

            The FDA regulates products according to their intended use. A product’s intended use determines what we can say about a product.  Regulators determine a product’s intended use by reviewing advertisements and promotional materials. 

Don’ts: Drug and Disease Claims

            Dietary supplement advertisements may not contain drug or disease claims.  Drug/disease claims are statements suggesting that a product is intended to diagnose, cure, mitigate, treat, or prevent a disease.  Broadly speaking, a disease is any condition in which a part of the body does not function properly (e.g., cardiovascular disease) or any state of health that leads to that dysfunction (e.g., hypertension).  Prohibited drug/disease claims may be express or implied. An express claim is one in which the claim directly links the product to a medical condition (e.g., “Use Product X and reduce the risk of developing bowel cancer.”). An implied drug/disease claim is an indirect statement about a product or ingredient that requires the consumer to make an inference to understand that the product is intended to diagnose, cure, treat, or prevent a certain disease.  For example, an implied disease claim may result when developing advertising copy that refers to the typical symptoms of a disease or citing to a study suggesting that a product’s ingredient can cure, mitigate, treat, or prevent a certain disease or its symptoms.

            General Characteristics of Drug/Disease Claims:

• A statement that a product or ingredient can diagnose, cure, mitigate, treat, or prevent any disease.
• A statement that the product or ingredient has an effect on the characteristic signs or symptoms of a disease.
• A reference to a particular study which contains the name a disease in its title.
• A statement that the product or ingredient is a substitute for a therapy for a disease.
• A statement that the product or ingredient has a role in the body’s response to a disease.

Examples of Prohibited Drug/Disease Claims:

• “Since being on [Cleanse Product] … he was given a clean bill of health… We believe he is healthy because [the product] cleansed [his cancer/diabetes].”
• “Protects against the development of cancer”
• “Helps remove heavy metals, biotoxins, solvents, pesticides, and chemicals that can contribute to body aches and pains”
• “Symptoms of Toxin Accumulation . . . include: . . . Forgetfulness/Mental Confusion, Mood Changes/Mild Depression, Anxiety . . . Insomnia, Body Aches and Pains . . . Nausea, Vision Problems”
• “Detoxify: Parasites, Bacteria, & Toxins”
• “Acute heart pain relief”
• “Decreases the effects of alcohol intoxication”
• “[Ingredient] is known as Nature’s Antibiotic”
• Statements that a product/ingredient is an “Analgesic,” “Antiviral,” “Diuretic,” “Antimicrobial,” “Antiseptic,” “Antidepressant,” “Vaccine,” or “Anti-inflammatory”
• “Depression”
• “Promotes cholesterol clearance”
• “Supports the body’s ability to resist infection”
• Chelato/chelator therapy: “Detoxification & Chelator. [Ingredient] … protects against toxins. [Ingredient] reacts directly with many poisons, including herbicides, drugs (acetaminophen), environmental pollutants such as carbon tetrachloride, microorganisms including E. coli and aflatoxin, and against heavy metals. Indirectly, [Ingredient] helps with detoxification by producing optimal amounts of GSH for conjugation reactions, making harmful compounds less toxic.”
• Pictures of organs that suggest prevention or treatment of a disease

Dos: The Three Types of Permissible Dietary Supplement Claims

1. Nutrition deficiency disease claims

This is a very limited exception to the drug/disease rule and will rarely, if ever, apply to Myers Detox’s advertising copy.  This type of claim describes how a product or the product’s ingredients can alleviate diseases related to a nutritional deficiency.  For example, claims regarding calcium and vitamin D’s potential to prevent osteoporosis are permitted. These claims are only permitted if the advertising copy discloses how widespread such nutrient deficiencies are in the United States.

2. Structure/function claims

Structure/function claims are not drug/disease claims.  Rather, these claims assert only that a dietary supplement stimulates, maintains, supports, regulates or promotes a proper function in the human body. Claims such as “supports liver health,” “promotes liver function,” and “support your immune system” are examples of permissible structure/function claims. Importantly, none of these claims describes how the supplement will take a person from a diseased state to a non-diseased state or otherwise implies some type of disease prevention or symptom relief.  Instead, these claims focus on the supplement/ingredient’s role in maintaining the proper function of the body generally or a specific organ or system. The vast majority of compliant dietary supplement claims fall into this category.

Additional Examples of Structure/function claim examples:

• “Energizer,” “rejuvenative,” “revitalizer,” “adaptogen”
• “For men/women over XX years old/during pregnancy”
• “Helps maintain regularity.”
• “Reduces stress and frustration”
• “Helps to maintain cholesterol levels that are already within the normal range.”
• “Hot flashes”
• “Provides nutritional support for XX”
• General claims re. “antioxidant” properties; “detoxify your body and mind”
• “stimulate,” “maintain,” “support,” “regulate,” or “promote” in association with a body system, organ, or function affected by the supplement

3. General well-being claims

This type of claim describes how consumption of an ingredient or supplement supports a person’s general well-being.  For example, “supports healthy digestion” or general statements about a person’s state of health.

General Dietary Supplement Advertising Guidelines

• Avoid references to specific diseases or conditions.
• Avoid references to symptoms commonly associated with a specific condition. For example, state that a product “may be used to help maintain balanced blood sugar levels” instead of “reduces blood sugar levels” or “reduces A1C.”
• Refer to states that exist absent a specific disease or condition (e.g., stress, mood, etc.).
• Avoid inferring or implying a relationship with a disease or condition:
  • Do not refer to a product as a substitute for a drug or therapy.
  • Avoid citations to scientific studies whose title indicates the treatment of a particular disease.
  • Do not make claims that associate the product with a drug or class of drugs that are known to prevent or treat a disease. (e.g., antibiotic, antidepressant).
• Use general statements that do not indicate that a product treats a specific disease or symptoms of a particular disease. For example, use “promotes a healthy immune system” instead of “supports the body’s ability to resist infection.” For detoxification claims, use general phrases such as “detoxify your body” and “embrace a toxin-free lifestyle” instead of discussing how a product can remove certain toxins from the body.
• Include the FDA-required disclaimer on all advertising copy:
  • “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
• All claims must be supported by competent and reliable scientific evidence. Just because a study references a particular ingredient does not mean that the study substantiates a claim. Determine whether the study addressed dosing and frequency and duration of exposure.
• Context matters. The overall net impression of an advertisement is what matters when determining whether an advertisement makes a drug/disease claim.

Guidelines for Detoxification Claims

• Do not make claims that removing heavy metals is a treatment or cure for any disease or medical condition (e.g., heart disease, autism).

Detox-Specific Advertising Guidelines

• General detoxification claims only. You may make claims that a product “detoxes” or “cleanses” the body; however, such claims should not be connected to the product’s ability to remove heavy metals from the body.

Prohibited: 

Permissible:

• Myers Detox’s [product] can help you detoxify your body and feel your best.”
• “Myers Detox’s [product] can help you detox from everyday living and help you maintain a clean and healthy lifestyle.”

• No toxicity claims. Do not use the terms “toxic,” “toxicity” “heavy metal toxicity” or the name of any metal in advertising copy.

Alternative Descriptors: “contaminants,” “pollutants,” “impurities,” “chemicals” or “hazards.” 

• Detox Claims should focus on the end result, not the mechanism of action. Advertising copy should rarely, if ever, claim that a particular product binds with a product.  Instead, explain how the product discourages the body from absorbing contaminants or pollutants and encourages/facilitates the body’s natural process of excreting waste and impurities.

Prohibited:

• “Product X binds to lead and other heavy metals in your cells and bones.”

Permissible

• “Myers Detox’s [product] can help block your body from absorbing environmental hazards.”
• “Healthily living means protecting our bodies from chemicals and pollutants; Myers Detox’s [product] encourages your body to excrete dietary impurities.”
• “Cleanse your body of everyday pollutants by giving your body the tools it needs to expel these substances.”

• Avoid using the word “symptoms” or referencing the symptoms of any disease or the symptoms of toxicity. Use alternative descriptors such as “signs” or “feelings.”  You may also reference physical sates that exist independent of a particular disease or metal toxicity.  For example, fatigue, stress, mental clarity, etc.  

Additionally, so long as the claim can be substantiated, you can make a structure/function claim about the particular symptom that is associated with a particular disease.  For example, heavy metal toxicity can cause hormone imbalances.  Create a structure/function claim by asserting that the product can assist the body with maintaining proper functioning.  Thus, one could say, “Detox product can assist the body maintain proper hormone levels and maintain energy levels.”  Note: Product claims must always be substantiated.

FTC Compliance – Truth in Advertising

            While the FDA focuses on a class of products (drugs), the FTC regulates all forms of advertising. The FTC requires that advertising claims be truthful and not misleading, deceptive, or unfair. An advertising claim is truthful if the advertiser can substantiate the claim.  That is, an advertiser must have a reasonable basis for making any claim about a product. 

Substantiating Dietary Supplement Claims

            The vast majority of dietary supplement claims are structure/function claims (see above). In order to show that a claim about a certain ingredient, or a product generally, is truthful, advertisers must demonstrate that the claim is supported by competent and reliable scientific evidence.

A guiding principle for determining the amount and type of evidence that will be sufficient is what experts in the relevant area of study would generally consider to be adequate. Regulators will consider all forms of competent and reliable scientific research when evaluating whether a claim is properly substantiated. As a general rule, well-controlled human clinical studies are the most reliable form of evidence. Results obtained in animal and in vitro studies may be helpful if they are widely considered acceptable substitutes for human research or where human research is not feasible. Although there is no requirement that a dietary supplement claim be supported by any specific number of studies, the replication of research results in an independently conducted study adds to the weight of the evidence. In most situations, the quality of studies will be more important than quantity. When a clinical trial is not possible (e.g., in the case of a relationship between a nutrient and a condition that may take decades to develop), epidemiologic evidence may be an acceptable substitute for clinical data, especially when supported by other evidence, such as research explaining the biological mechanism underlying the claimed effect.

Do not assume that merely finding a study testing the same substance that is contained in a product constitutes adequate substantiation.  A study must show that there is a strong relationship between the substances being studied and the supplement claim. Important factors include similarities in:

• Formulation
• Serving size/dosing
• Route of administration
• Total length of exposure; and
• Frequency of exposure

Endorsements and Testimonials

            If endorsements and testimonials are used for advertising, Myers Detox (as well as affiliates advertising on Myers Detox’s behalf) must disclose any material connection between the endorser and Myers Detox. For example, we must disclose whether a person giving a testimonial was paid for their testimony or received something in-kind (e.g., given free samples). Likewise, if a person advocating for a product is an employee, family member, or otherwise connected to Myers Detox, that connection must be disclosed. It is not necessary that you get in the details of the connection, but that you should identify that the connection exists. For example, the ad copy could say, “Consumers received compensation in exchange for sharing their experiences” or “I gave my friends free product to see how they liked it and this is what they said.”

Importantly, Myers Detox may not use endorsements or testimonials to make claims that Myers Detox cannot otherwise make.  For example, a customer may love a dietary supplement so much that they credit the product for curing their disease or alleviating the symptoms of their disease. Regardless of how genuine the testimonial may be, the testimonial makes a prohibited drug/disease claim about a dietary supplement and cannot be used. This prohibition applies equally to testimonials/endorsements from medical professionals and experts in a particular field.  The FDA is the only authority that can approve a certain ingredient or product for use in treating or preventing any disease.  Use care when relying on medical professionals to substantiate a claim because regulators may view the advertisement as an express or implied drug/disease claim.

            Anyone who gives a testimonial must be qualified to do so.  That means the person giving the testimonial must be someone who:

1. Actually used the product;
2. Shares a true and accurate account of their experience using the product; and
3. Whose experience can be substantiated and is representative of what consumers will generally achieve.

            If the person’s experience is not representative, Myers Detox must disclose that the results are not typical or explain the typical results, and include a disclosure that “results may vary.”