LIFE SCIENCES/FDA & FTC LAW
From dietary supplement claims and labeling, to cosmetics, medical devices, and wearable health tech, we navigate enforcement hazards so your products get to market and stay clear of regulatory hazards.
The Michael H Cohen Law Group was founded in 1999 to represent health and wellness products and technologies, practices, and ventures, that fuel the ability of healthcare technology to accelerating health and healing.
ADVERTISING AND MARKETING (CLAIMS)
Our advertising and marketing compliance attorneys are highly skilled in Federal Trade Commission (FTC) and state law regulatory issues and enforcement matters.
How “Intended Use” Affects Your Product’s Regulation It is the “intended use,” as established through product labeling, that can cause the FDA to consider a product to be a drug.
Our biotechnology and life sciences lawyers understand FDA, FTC, and relevant state laws that apply to your business.
Our law firm counsels both individual clinicians and companies about FDA, FTC, and state law rules governing off-label use.
We help our clients with FDA issues related to medical devices, including:
- Classification of Medical Device (Class I, II or II)
- Establishment Registration
- Medical Device Reporting (MDR)
- Premarket Notification (510(k))
- Premarket Approval (PMA)
- Regulatory Requirements such as Quality System Regulation/Good Manufacturing Practices
- 513(g) Letter (arguing that product is not a medical device)
COSMETICS AND NUTRACEUTICALS
“Cosmeceutical” and “nutraceutical” are industry names for products that present hybrid qualities—for example, a cosmetic or a dietary supplement with therapeutic properties.
Our legal team’s focus on cosmetics, dietary supplements, and medical devices gives us the expertise to help clients navigate FDA and FTC issues.
DIETARY SUPPLEMENTS (CLAIMS AND LABELING)
We can review or prepare labels and advise your company regarding products requiring FDA/FTC-compliant labeling such as dietary supplements, nutraceuticals, or cosmetics.
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”