Dietary Supplement Legal & Compliance
Guidance
Guidance
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 the 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 defines explicitly 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.
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.
Regulation of Claims and Labeling
Once we know that the 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”). The FDA will regulate dietary supplements that make disease claims 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 essential to respect nuanced labeling rules, including those regarding the statement of identity. Put another way, nuances in verbiage are necessary so that the FTC, as well as the FDA, do not initiate any enforcement action.
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 that only a creative and knowledgeable 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
- 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 regulations
- Laws governing the 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 a 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, homeopathic, and other products. Legal issue-spotting is part of what a knowledgeable 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 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 hemorrhoids, 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 develop 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 develop 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 develop 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 Supplement Health and 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 prominently displayed.
- “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 violates an applicable regulation issued under section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602)
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
