Manufacturers of new dietary supplements, cosmetics, and nutraceuticals can find legal advice about labeling and FDA-compliant claims by following these guidelines.
Legal Advice For New Dietary Supplement, Nutritional Product or Cosmetic
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.
· Cosmetics and cosmeceuticals
· Electronic radiation products
· Energy medicine devices
· 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
· Criminal prosecutions
· Refusal of goods
· Customs penalties
· Import alerts
· Civil monetary penalties
We also understand the state-law side which can include these legal issues:
· 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:
o Nutrient Content Claims
o Structure-function claims
o Health Claims
o Qualified health claims
o 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 a certain skin condition. 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” (or various other conditions in the clients' product line) 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
Some of the legal tasks to consider in dietary supplement and other FDA regulation include providing the following kinds of legal advice:
o 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?
o 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?
o 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?
o Do the product names, claims, and indications comply with state law, including legal rules governing deceptive advertising and false and misleading claims?
o Do the product names, claims, indications, and ingredients comply with relevant OTC drug regulations?
o 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.
o Are the claims backed by sufficient scientific substantiation and compliant with FDA and FTC guidelines?
o 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.
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:
o "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];
o "it consists in whole or in part of any filthy putrid, or decomposed substance";
o "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";
o "its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or
o 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).
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—
o "its labeling is false or misleading in any particular";
o its label does not include all required information;
o the required information is not adequately prominent and conspicuous;
o "its container is so made, formed, or filled as to be misleading";
o 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
o "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.
Materials to Review
1. Review and Provide Legal Advice on Product Names and Claims/Indications for Health or Nutrient Content Claims
- 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
- 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 Labeling Guide (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
Although we find that an hourly rate often works best due to the fact that clients frequently upgrade or, conversely, downshift the scope of a proposed project, due to our experience, we are willing to discuss a flat legal fee or other alternative billing arrangement. Please contact our law firm for details.
Healthcare & FDA attorney Michael H. Cohen is a thought leader in healthcare law & FDA law, pioneering legal strategies in healthcare. wellness, and lifestyle markets. As a corporate and transactional lawyer, FDA regulatory attorney who also handles healthcare litigation, healthcare mediation and healthcare arbitration, and international healthcare & wellness law speaker, Los Angeles / Bay Area healthcare & FDA lawyer Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek healthcare & FDA attorney Michael H. Cohen's legal savvy on all aspects of business law, healthcare law, and FDA law, including:
- business structure and entity formation (corporations, partnerships, LLCs)
- health care facility licensing issues (home health agency, hospice, imaging center)
- practitioner licensing matters;
- physician and allied & complementary medicine provider employment contracts and independent contractor agreements
- e-commerce (including online health education and mobile medical apps) legal
- copyright & trademark, licensing
- informed consent and liability risk management
- HIPAA and confidentiality and privacy issues
- Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions
- cosmetics claims, labeling
- OTC drug & homeopathics FDA legal review
- medical device FDA legal issues
- dietary supplement claims and labeling
- insurance reimbursement and Medicare issues for healthcare practitioners
- concierge medicine legal issues
- telemedicine legal, m-health, and digital health law
- business law and health care regulatory compliance arenas
- healthcare meditation and healthcare arbitration.