Dietary Supplements - Claims and Labeling Compliance for FDA/FTC

We can review or prepare labels and advise your company regarding products requiring FDA/FTC-compliant labeling such as dietary supplements, nutraceuticals, or cosmetics. We will assist with FDA compliance regarding foods, dietary supplements, drugs, or medical devices. We can determine whether product names and claims cause the product to meet the FDCA definition of “drugs” by making implied disease claims (versus allowed structure/function claims). We can review client’s evidence of substantiation of claims in light of federal and state substantiation requirements, and draft compliant disclaimers. In addition, we can provide legal review & advice relating to Marketing Materials (including brochures and main website) in light of FDA and FTC issues concerning claims, testimonials & endorsements.

The Dietary Health Safety and Education Act of 1994 (“DSHEA”) amends the federal Food, Drug & Cosmetic Act (“FDCA”), the foundational federal law governing foods, drugs, cosmetics, and medical devices.

Definition of Dietary Supplement
The DSHEA specifically defines a “dietary supplement” as:

  • a product taken by mouth
  • that is “intended to supplement the diet”
  • and that contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above;
  • further, the product must be labeled as a dietary supplement, and,
  • must not be represented for use as a conventional food or as the sole item of a meal or the diet. (Note: this part of the definition does not mean that we are only talking about weight loss or dietary products.) The key regulatory impact of the DSHEA is that a product that meets the definition of a “dietary supplement” does not need FDA approval of safety and effectiveness before being marketed.

We guide clients who have products that are more properly regulated as beverages (foods). Lines can blur — for example, consider a bottled water drink containing vitamins. We also counsel regarding regulation of a product as a food additive.

Regulation of Claims and Labeling
Once we know that product will be regulated as a “dietary supplement,” we generally focus on two sets of legal rules relevant to marketing: (1) rules governing claims that can be made regarding the product, and (2) rules governing labeling for the product.

Claims come in four basic varieties:

  • structure/function claims
  • disease claims
  • health claims and qualified health claims
  • nutrient content claims.

Basically, dietary supplements cannot make “disease” claims (for example: “this supplement shrinks tumors”). Dietary supplements that make disease claims will be regulated by the FDA as drugs.

Dietary supplements can make “structure/function” claims (for example, “calcium builds strong bones”). A structure/function claim describes the product’s role in maintaining the “structure or function of the body,” or “general well-being.”

Labeling rules are detailed. Depending on the ingredients, different rules come into play. For example, one of these rules provides that the “principal display panel”—the main panel for the supplement—must provide a “statement of identity” for the product.

The Federal Trade Commission (“FTC”) has overlapping jurisdiction with the federal Food and Drug Administration (“FDA”), and focuses more on whether advertising is truthful, or false and misleading. Thus, it is important to respect nuanced labeling rules, including those regarding the statement of the identity.

Put another way, nuances in verbiage are important so that the FTC, as well as the FDA, do not initiate any enforcement action.

This section continues in the following parts (click to expand):

Legal Advice For New Dietary Supplement, Nutritional Product or Cosmetic

“Maintain compliance while maximizing revenue”

Question: I have a dietary supplement, cosmetic, or medical device that I want to bring to market. What kind of legal issues are involved, what are my risks vis-à-vis the federal Food and Drug Administration (FDA) and FDA law, and what will it cost for advice?

Answer: Seeking legal advice in bringing a product to market can seem like looking at your business plan through a funhouse mirror. Federal and state laws provide hurdles which only a creative and knowledge health care and business law attorney can successfully navigate.

Fortunately, the legal team in our law offices has experience answering FDA regulatory questions whether they involve:

  • Biologics
  • Biotechnology
  • Cosmetics and cosmeceuticals
  • Electronic radiation products
  • Energy medicine devices
  • Foods
  • Homeopathic medicines
  • Homeopathic resonance devices
  • Medical devices
  • Medical foods
  • Nutritional products
  • OTC drugs
  • Pharmaceutical drugs
  • Varieties of other consumer products.

Our skilled food and drug law attorneys have represented dietary supplement, cosmetics, and medical device manufacturers and distributors in many different kinds of ventures and arrangements. We understand FDA laws governing dietary supplements, labeling issues, and the rules that apply to nutritional therapies as opposed to drugs, cosmetics, devices, and other therapeutic vehicles. We are familiar with FDA enforcement tools, which include:

  • Warning letters
  • Injunctions
  • Criminal prosecutions
  • Detentions
  • Refusal of goods
  • Customs penalties
  • Import alerts
  • Civil monetary penalties

We also understand the state-law side which can include these legal issues:

  • unlicensed medical practice
  • malpractice
  • professional discipline
  • informed consent
  • scope of practice
  • practice guidelines
  • disclosure and other legal requirements pertaining to non-licensed CAM and other health law professionals; and
  • other health care legal issues.

Our FDA lawyers can give clients critical legal advice concerning:

  • The legal status of proposed dietary supplements and dietary supplement labels
  • The legal status of new dietary ingredients
  • Preparation of notices to the FDA concerning proposed claims
  • FDA rules governing Current Good Manufacturing Practices (cGMPs)
  • Legal advice concerning FDA-compliant labeling, including regulation of:
    • Nutrient Content Claims
    • Structure-function claims
    • Health Claims
    • Qualified health claims
    • Organic claims
  • Legally compliant labeling including label information regarding “supplement facts”
  • Legal review of website, third-party literature, advertising, and marketing content
  • FTC-compliant guidance concerning evidentiary substantiation of claims
  • Legal advice concerning claims relating to clinical investigations of dietary supplements
  • Contract advice and drafting for clinical studies and other research involving dietary supplements
  • Legal advice for compliance with FDA import and export regulation
  • Laws governing reporting of adverse events
  • Legal issues surrounding recalls
  • Research of relevant FDA warning letters concerning dietary supplements, cosmetic products, nutraceuticals, cosmeceuticals, and homeopathic products
  • Legal guidance with respect to FDA enforcement actions including FDA seizures, injunctions, and investigations

 

Example: Manufacturer and Distributor of a New Dietary Supplement Product

Here is a case example of the way we might handle a particular legal project. One of our law firm’s clients called seeking legal review of website to bring a product to market that would help with hemorrhoids. The client had two products, one to be taken orally (by mouth) and the other, a topical gel. The client was concerned about what it might take to review the website.

Unfortunately, when potential clients price-shop, seeking the lowest quote, they get what they pay for. Lawyers unfamiliar with state and federal food and drug law and related legal rules may miss some critical legal issues that can hamstring the long-term viability of their dietary supplement, cosmetic, over-the-counter (OTC) drug, or medical device business.

In this case, our health care law attorneys realized that the client needed more than website review. The very first issue was whether using the term “hemorrhoids” creates an unlawful disease claim, bringing the product into the FDA category of a new drug. Enforcement personnel will search the Web for keywords, and even invoke meta-tags in compiling a warning letter against non-compliant manufacturers and distributors of dietary supplements, cosmetics, gels, and homeopathic and other products.

Legal issue-spotting is part of what a knowledge health care and business attorney does. In this case, both the website and the website were making disease claims — cheeky, if you’ll pardon the pun — and legally risky; and in addition, the client’s proposed labeling did not comply with existing regulations. Had the client simply looked for the cheapest hired gun, the client would have saved money on the initial legal consultation and tweaked the website, but would not have realized that the entire business model needed rethinking. We advised looking at the product name, labeling, and indications and creatively analyzing other possible ways to market a natural product aimed at symptoms of hemmorrhoids, without running afoul of FDA and state-related laws. In addition, the topical gel needed attention as a possible OTC drug.

Typical FDA and Related Legal Issues

We provide legal advice with respect to new dietary supplements and cosmetics as follows:

Does the product name make a legally impermissible “disease claim,” “health claim,” “quasi-health claim,” or “nutrient content” claim? Alternatively, for a dietary supplement product, can our health care lawyers help the client come up with a legally compliant structure-compliant claim?

Does the product label (including the website and other literature) make a legally impermissible “disease claim,” “health claim,” “quasi-health claim,” or “nutrient content” claim? Alternatively, for a dietary supplement product, can our health care lawyers help the client come up with a legally compliant structure-function claim?

Do the product indications (for example: for relief of _____ ) make a legally impermissible “disease claim,” “health claim,” “quasi-health claim,” or “nutrient content” claim? Alternatively, for a dietary supplement product, can our health care lawyers help the client come up with a legally compliant structure-compliant claim?

Do the product names, claims, and indications comply with state law, including legal rules governing deceptive advertising and false and misleading claims?

Do the product names, claims, indications, and ingredients comply with relevant OTC drug regulations?

Do the product labels comply with federal labeling requirements for OTC drugs, dietary supplements, cosmetics, or homeopathic medicines? Section 602 of the federal Food, Drug & Cosmetic Act (“FDCA”) provides that an article is considered misbranded if it contains:

  • false or misleading labeling;
  • fails to state prominently and conspicuously any information required by or under the federal FDCA;
  • a misleading container presentation or fill Section 301 of the FDCA gives the FDA the authority to enter the establishments of noncompliant firms and inspect their facilities as well as all pertinent equipment, finished and unfinished materials, containers and labeling. Sec. 704(a) of the FDCA and the FDA website on Good Manufacturing Practice. Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of dietary supplements and cosmetics.

Are the claims backed by sufficient scientific substantiation and compliant with FDA and FTC guidelines?

Do the website and marketing materials require FDA and FTC compliant disclaimers and other legal notices?

The reason these legal issues are important is because of federal regulation in this arena. Dietary supplements are regulated under the DSHEA (Dietary Supplements Health Education Act of 1994), which is incorporated into the FDCA, and cosmetics under the DSHEA as well as the Fair Packaging and Labeling Act (FPLA). The FDCA prohibits the marketing of adulterated or misbranded dietary supplements and cosmetics in interstate commerce.

Adulteration

Violations of the FDCA involving product composition — whether they result from ingredients, contaminants, processing, packaging, or shipping and handling — cause cosmetics to be adulterated and subject to regulatory action. Under the FDCA, a cosmetic is adulterated if one of the following is true:

  • “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [with an exception made for hair dyes];
  • “it consists in whole or in part of any filthy putrid, or decomposed substance”;
  • “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
  • “its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or
  • except for hair dyes, “it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FDCA (sec. 601).

Misbranding

Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if—

  • “its labeling is false or misleading in any particular”;
  • its label does not include all required information;
  • the required information is not adequately prominent and conspicuous;
  • “its container is so made, formed, or filled as to be misleading”;
  • it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
  • “its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602)

In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FPLA.

Legal Issues Checklist

Legal Review of Dietary Supplements, Cosmetics, Nutraceuticals and Cosmeticals

In the chart below, our law firm’s FDA attorneys outline some of the major issues requiring legal review.

Task Materials to Review
1. Review and Provide Legal Advice on Product Names and Claims/Indications for Health or Nutrient Content Claims Review for:

  • nutrient content claims
  • health claims.
2. Review Product Names and Claims/Indications for Implied Disease Claims (vs. allowed structure/function claims) and Advise Check whether product names and claims make product meet the FDCA definition of “drugs” by making implied disease claims. Include all labeling in review (i.e., website material within one click of product claims and any brochures). Specifically, check product names and claims against:

  • FDA, Certain Types of Statements for Dietary Supplements
  • FDA Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure of Function of the Body (Jan. 6, 2000)
  • Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide (Jan. 9, 2002)
  • FDA warning letters
  • Case law
  • Law review articles
  • Comparable products as appropriate
3. Review Product Names and Claims/Indications against State Law and Provide Legal Advice Review:

  • State food and drug law.
  • State consumer protection act (i.e., re weight loss programs).
  • Review state law governing deceptive advertising and false/misleading claims (pertaining to weight loss).
4. Review Product Names, Claims/Indications, and Ingredients, for OTC Drug Regulation and Give Legal Advice Review OTC regulations to assess how impermissible claims relating to disease categories and ingredients might bear on structure-function claims and necessary disclaimer (i.e., regarding obesity):

  • Regulation of Certain Active Ingredients
  • OTC Ingredient List (by Monograph Category)
  • Status of OTC Rulemakings by Therapeutic Category
5. Draft Labels or Review Existing Labels Against FDA Labeling Requirements Review labels in light of

  • FDA, Guidance for Industry: A Dietary Supplement LabelingGuide (April 2005)
  • FDA, Guidance for Industry: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Small Entity Compliance Guide
  • 21 CFR 101—Food Labeling
6. Substantiation & Notices Review client’s scientific substantiation of claims in light of:

  • FDA substantiation requirements.
  • FTC substantiation requirements.
  • Consumer Protection Act in relevant state (MI)
  • Food, Drug & Cosmetic Act in relevant state

Notify FDA within 30 days of marketing any new dietary supplement claims. Also notify if any new dietary ingredients.

7. Legal Review Website and Draft Compliant Disclaimers Review website and draft:

  • FDA disclaimer re statements and claims
  • FTC disclaimer re testimonials and opinions
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