Label Compliance & Claims Support

From supporting niche, specialty products to the largest national brands, ISS provides the following rigorous labeling and claim support services for US and EU:

• Label and promotional compliance review
• Compliance training
• Claim substantiation reviews and assessments
• Ingredient safety reports
• Formulation reviews and assessments

Some of the more common types of label compliance and substantiation projects that we are called upon to perform are listed below:

• Drug & Dietary Supplement Label Compliance: ISS has evaluated, revised, and drafted labels for hundreds of drugs and dietary supplements over the past 20 years. We have an intimate knowledge of the relevant standards, requirements, and guidance documents for label compliance and can ensure that the product labeling conforms to the appropriate regulations.
• Drug and Dietary Supplement Claim Substantiation Reports: ISS develops rigorous claim substantiation assessment reports that help clients ensure that their product advertising is well supported by competent and reliable scientific evidence. Our skilled scientific team aligns the evidence with your marketing claims, providing you with documentation of effectiveness in crisp, easy-to-review report format.
• Drug and Dietary Supplement Ingredient Safety Reviews: ISS reviews the relevant scientific literature to ensure that your formulation meets the relevant regulatory requirements. We also can prepare and submit GRAS notices to FDA as required.