Even though there is no requirement of premarket approval (unlike the case for drugs, which require FDA approval for safety and effectiveness), dietary supplements are in fact subject to a maze of regulation.  This includes both FDA (Food and Drug Administration) and FTC (Federal Trade Commission) rules to ensure that dietary supplements:

• have proper claims (for example, structure-function and not disease claims)
• where claims are properly substantiated (by competent and reliable scientific evidence)
• and consumers are not given false or misleading statements
• endorsements and testimonials must comply with FTC rules
• claims can be implied as well as express
• marketers must respect rules concerning third-party literature

In Consumer Justice Center v Olympian Labs, Inc, 99 Cal.App.4th 1056 (Ct. App., 4th Dist., 2002), the California Court of Appeal bluntly stated that a particular section of the DSHEA (codified at 21 USC section 343(r)):

is not the clearest legislation ever written. To be truthful, it is a nightmare of internal cross-references which makes parts of the Internal Revenue Code read like Hemingway in comparison.

 As an example, the Court quoted the following:

“A statement of the type required by paragraph (q) of this section that appears as part of the nutrition information required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (B).”

Typically, a legal consult involving dietary supplement labeling focuses on three important legal issues: the claims being made; the labeling; and substantiation.

Be sure to seek an attorney who is well-versed in all aspects of FDA and FTC laws and regulations before bringing new dietary supplement products to market.

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Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek Michael H. Cohen’s legal expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas.  Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. Attorney Michael H. Cohen is admitted to practice law in California, Massachusetts New York, and Washington, D.C.  Contact our attorneys  firm today.