FDA Label Consulting and Website Review Services
Are the labels on your products in full compliance with all FDA regulations? Does the copy on your website follow all FDA rules for marketing and promotions?
If you can't answer with an emphatic "yes," FDA Compliance Group can help. Our team of FDA consultants includes industry experts and former FDA employees, who are well-versed in the nuances of FDA labeling and website review processes.
What is an FDA Label Review?
An FDA label review is a formal evaluation process or "compliance audit" that examines product labels, packaging, and materials (like food, drugs, medical devices, or cosmetics) to ensure Food and Drug Administration (FDA) compliance.
Why FDA Labeling Reviews and Compliance Matter
As part of its oversight of the pharmaceutical/OTC, dietary supplement, medical device, cosmetic, and food & tobacco industries, the FDA routinely reviews product labels and websites for accuracy and claims. The FDA mandates accurate labeling to protect consumers from misleading info, health risks, or false claims. Non-compliance with FDA regulations, such as incorrect or misleading labels and online content, can trigger regulatory actions like recalls, product seizures, or legal penalties against your business.
Our FDA label consultants can help you stay in FDA label compliance by reviewing your product labels, packaging, and website content so your claims and information align with FDA expectations.
Our FDA Label Compliance Expertise
FDA Compliance Group has expertise in all major areas of labeling and packaging, including:
- FDA dietary supplement labeling and Supplement Facts Panel requirements
- FDA food labeling and Nutrition Facts Panel requirements
- GMO (Genetically Modified Organism) labeling
- Organic labeling and related claims
- Medical device labeling requirements
- Pharmaceutical/OTC labeling requirements
- Tobacco labeling requirements
- FDA label warnings and disclaimers
- FDA menu labeling requirements
- FDA contact lens labeling
- FDA cosmetics labeling
Our goal is to help make sure your labels and marketing materials are accurate, clear, and compliant.
Website and Marketing Content Reviews
In addition to product labels and packaging, FDA Compliance Group can review your website copy, online product descriptions, marketing and promotional claims, structure/function claims, health-related claims, and consistency between labels, packaging, and online information. We can identify statements that may be viewed as misleading, unsubstantiated, or drug-like claims for supplements and cosmetics, to suggest an FDA label compliant alternative.
Related FDA Regulatory Services
We also provide related FDA regulatory labeling and submission review services, to complement our labeling and website reviews, to help you maintain consistent and compliant messaging across your products and channels. These services include:
- NDA (New Drug Application)
- ANDA (Abbreviated New Drug Application)
- NDI (New Dietary Ingredient) submissions
- GRAS (Generally Regarded as Safe) affirmations
- Structure / Function Claims for food and dietary supplements
- FSVP support
- 510k, Premarket Notification (PMA), DeNovo
- Clinical Trial development/management
For more information about FDA label reviews or website reviews, or to schedule a consultation, please contact us at (303) 903-4801.