Regulatory Compliance for Cosmetics, Nutrition, and Cannabis Companies – Part 1

Most everyone wants to look and feel better. People want to look younger and have more energy. People want to live longer. Cosmetics mostly target a person’s facial appearance but cosmetics can be used on other parts of the anatomy as well. Good nutrition is generally good for the heart, for keeping healthy weight levels, and as a complement to exercise helps people feel better. Health advocates claim that nutrition and exercise are essential ingredients for a longer life. Many companies are now selling different varieties of cannabis products you can drink, eat, apply, or use that claim to improve your outlook on life. Many cannabis companies also, often improperly, make medical and therapeutic claims about the company’s cannabis products.

General legal issues for new cosmetics, dietary supplement, nutritional products, and cannabis products

We understand the time and great expense companies spend to get business ideas started and to implement those ideas so the business become profitable. We also understand the complex federal and state rules that govern cosmetics, dietary supplement, nutritional products, and cannabis products. We generally advise that sooner you see experienced healthcare business and compliance lawyers the better.

When you wait, it becomes harder to address things that are wrong and to craft the proactive solutions that help businesses thrive. When you wait, you may need to do more than just cease your current manufacturing, distribution, and marketing activities – you may need to spend a fortune redesigning the products and promotions, retraining your staff, and reworking your customer relations.

Our lawyers review numerous legal issues for clients who make and sell cosmetics, dietary supplements, and cannabis products. Our review begins with FDA and FTC compliance oversight. We review how the products are classified, what claims are made about the products, the labeling and marketing of the products, and client testimonials. This review includes analyzing and responding to claims the products are misbranded or adulterated – and are actually drugs or other unauthorized products. The review also studies and prepares for complaints that the products make improper health claims.

The names of the products also need to be reviewed because some names make implied promises. We provide counsel on whether your products should be labeled as a beverage or a food additive.

The legal team in our law offices has experience answering FDA and FTC regulatory questions including questions about:

  • Biologics
  • Biotechnology
  • Cannabis products
  • Cosmetics and cosmeceuticals
  • Dietary supplements
  • 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.

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 legal issues:

  • Unlicensed medical practice
  • Malpractice
  • Professional discipline
  • Informed consent
  • Scope of practice guidelines
  • Disclosure and other legal requirements pertaining to non-licensed cam and other health law professionals
  • Other health care legal issues

Regulations of cosmetics

Cosmetics are governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Cosmetic manufacturers, distributors, and sellers are generally responsible for ensuring that the products comply with the FD&C Act. Failure to comply with the Act usually starts with a warning letter from the FDA. Often, the FDA will assert that the cosmetics are actually drugs, that the cosmetics are misbranded, that the cosmetics are adulterated, or that there are other violations of the Act. The Federal Trade Commission may also send a warning claims based on deceptive or unsubstantiated claims.

Our FDA & FTC compliance lawyers help you act proactively by understanding when claims and products may violate the federal laws. We help you takes steps to show your company is working to comply with the laws. When warning letters are sent, we help you show that you are working towards compliance. Warning letters may escalate into lawsuits which can results in fines, statutory penalties, other financial damages, and the possible cessation of your business.

Some of the many types of cosmetics clients we help include:

  • Manufacturers
  • Distributors
  • Advertisers
  • Importers
  • Resellers
  • Companies that target products to:
    • Beauty business companies
    • Weight loss companies
    • Overall health companies

We help you understand your business needs, your compliance requirements, your financial opportunities, your potential markets and how you can reach those markets, and other legal issues.

How are cosmetics defined?

FDA defines cosmetics as:

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.”

FDA may, however, define an apparent cosmetic products as a:

  • Biologics
  • Dietary Supplement
  • Drug (prescription (Rx) or OTC)
  • Food
  • Medical Device
  • Medical Food

Biologics and medical devices generally require premarket approval. Generally, dietary supplements and cosmetic products (color additives are an exception) don’t require FDA premarket approval.

Generally, if the company involved with the product makes therapeutic claims (such as that a skin lotion can treat a skin disease), then the product may be considered a cosmetic AND a drug.

Some acceptable claims that FDA generally authorizes regarding cosmetics are that the cosmetics help to:

  • Clean skin
  • Make a person look more beautify
  • Make a person look prettier
  • Changes a person’s appearance – in a positive way

For example, cosmetics are often promoted as moisturizers.

Other claims may be circumspect depending on the nature of the claim or promise.

Misbranding of cosmetics

Cosmetics that are improperly labeled, packaged, or marketed may be “misbranded” which can result in warning letters being sent and other regulatory actions. FD&C Act will consider a cosmetic misbranded if:

  • “The label contains any false or misleading information, or is false and misleading by failing to include all the required information.
  • The label lacks required information.
  • The required information is not sufficiently conspicuous and prominent.
  • The packaging is misleading.
  • There is improper packaging and labeling of color additives, and
  • The packaging has deficiencies where the Poison Prevention Packaging Act requires special packaging.”

How can an experienced healthcare and FDA/FTC lawyer help your cosmetic company?

Our array of legal services includes:

  • “Defense of FDA Inspections, Investigations & Administrative Detentions”
  • Drafting of contracts including:
    • Distributor contracts
    • Licensing contacts
    • Marketing agent contracts
    • Sales representative contracts
  • Advice on FDA Regulatory Compliance including responding to warning letters
  • Advice on FTC Regulatory Compliance
  • Guidance involving product substantiation and clinical studies
  • Labels and packaging
  • Reviewing company advertising marketing (online and print)
  • Infomercials
  • Retail displays
  • Testimonials and endorsements
  • Websites”

What are dietary supplements?

The Dietary Health Safety and Education Act of 1994 (DSHEA) amends the federal Food, Drug & Cosmetic Act (‘FD&C ACT’). The FD&C Act regulates cosmetics, dietary supplements, drugs, medical devices, and other products.

The DSHEA specifically defines a dietary supplement as:

“A product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients:

  • A vitamin
  • A mineral
  • An herb or other botanical
  • An amino acid
  • A dietary substance for use by man

[intended] to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E).”

Dietary supplements must be labeled as dietary supplements.

Dietary supplements “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.”

How can an experienced healthcare and FDA/FTC lawyer help your dietary supplement company?

We review dietary supplement laws and regulations at the federal and state levels. Once it’s clear the product you make, sell, or use for your customers is a “dietary supplement,” we focus on the two primary sets of marketing issues:

  • Labeling requirements. There are specific do’s and don’ts. “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.’”
  • Promotional claims. There are rules on how far you can and can’t push the limits in promoting dietary supplements. Generally, healthcare claims “come in four different varieties:
    • Structure/function claims. This type of claim “describes the product’s role in maintaining the ‘structure or function of the body,’ or ‘general well-being.” Some claims such as that ‘calcium builds strong bones’ may be approved. Claims that promise too much are likely to raise concerns.
    • Disease claims. Any claims a dietary supplement can treat or cure a disease are “red flags.” FDA warning letters regularly assert that these claims mean the dietary supplements are drugs and must then be regulated as drugs.
    • Nutrient content claims. The claims must match the actual nutrients in the dietary supplement.
    • Health claims and qualified health claims. We’ll review this on a product by product and claim by claim basis.

Our FDA lawyers advise dietary supplement clients about the following issues too:

  • “The legal status of proposed dietary supplements and dietary supplement labels”
  • “FDA rules governing Current Good Manufacturing practices (cGMPs)”
  • “Preparation of notices to the FDA concerning proposed 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.”

Manufacturers, distributors, and retailers of cosmetics, dietary supplements, cannabis products (CBD products), energy medicine devices, medical foods, and other products that people apply, ingest, or use to improve themselves need to know the laws that apply to them. The FDA and FTC and other federal and state agencies will monitor your claims and promotions. There are severe consequences if your product is categorized as a drug. There are consequences for making claims that mislead the public. An experienced healthcare lawyer reviews your compliance and business needs before you open your business, when you want to expand, and when your receive complaints and warning letters.

Contact Cohen Healthcare Law Group, PC to review the regulatory compliance and business needs of your cosmetic, dietary supplement, or cannabis business. Our experienced healthcare attorneys advise manufacturers, distributors, retailers, and other businesses about their federal and state regulatory requirements.

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