Label Compliance Reviews
Your label is more than just marketing—it’s a legal document. Regulatory missteps can lead to rejected shipments, fines, product recalls, or even litigation. At Sci Strive, we conduct thorough label compliance reviews to ensure your product meets FDA, FTC, USDA, and retailer-specific requirements, reducing risk while keeping your brand’s messaging intact.
Label Compliance Reviews
Dietary Supplements
Dietary supplement labels must strike the right balance between marketing appeal and regulatory compliance. We review:
Proper Supplement Facts panel formatting
Ingredient and allergen declarations
Structure/function claims to avoid unauthorized drug claims
Compliance with FDA and FTC regulations
Food & Beverage
Food labels must comply with FDA, USDA, and retailer guidelines while staying consumer-friendly. Our reviews cover:
Nutrition Facts panel accuracy and formatting
Ingredient statements and allergen declarations
Health claims (e.g., "low sugar," "high protein") for compliance with FDA regulations
Label design compliance for e-commerce and retail display
OTC Drugs
OTC drug labels must follow strict FDA monograph requirements to avoid enforcement actions. We ensure compliance with:
Drug Facts panel formatting
Active ingredient listing and dosage guidelines
Required warnings and usage instructions
Cosmetics
Cosmetic labels often blur the line between marketing and medical claims—which can be a major compliance risk. We review:
Ingredient labeling in compliance with INCI and FDA requirements
Proper categorization as a cosmetic vs. drug
Claims that could trigger regulatory enforcement
Cosmetic/OTC Hybrid Products
Products that combine cosmetic and drug claims (e.g., anti-aging creams with SPF, acne treatments, medicated lip balms) face dual compliance challenges. We ensure these labels:
Correctly classify the product under FDA regulations
Meet both cosmetic and OTC drug labeling requirements
Avoid misleading claims that could invite legal action
Risk Assessment for Regulatory Enforcement & Litigation Triggers
Certain claims and labeling mistakes can increase the risk of regulatory enforcement, consumer lawsuits, or class actions. We conduct risk assessments to identify potential triggers, such as:
Unsubstantiated health claims that could attract FDA or FTC scrutiny
"Natural" and "clean" claims that may lead to consumer litigation
Misleading serving sizes or ingredient disclosures that could result in recalls or lawsuits
At Sci Strive, we help businesses stay ahead of compliance risks while keeping labels compelling, clear, and legally sound. Before your label goes to print, let’s make sure it’s right.
Does this sound familiar?
- You received a cease-and-desist letter because your label includes unapproved health claims.
- A retailer pulled your product from their shelves because your allergen labeling was incorrect.
- You’re launching a new cosmetic product, but you’re not sure if your claims will trigger regulatory enforcement.
Don’t worry — we can help.