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Regulatory Law
Navigating the complex regulatory landscape for oral care products requires specialized legal expertise. Our firm focuses exclusively on regulatory law as it pertains to oral care, providing comprehensive counsel on compliance with federal agencies such as the Federal Trade Commission (FTC), Food and Drug Administration (FDA), and the American Dental Association (ADA). We help clients interpret and apply guidance from the National Advertising Division (NAD), ensuring that all marketing and advertising claims for oral care products are substantiated and compliant with evolving standards.
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Our team advises on every aspect of product label compliance, from ingredient disclosures to warnings and directions for use. We understand the intricacies of FDA labeling requirements and can assist with the development and review of packaging to minimize regulatory risk. Whether you are launching a new toothpaste, mouthwash, or other oral hygiene product, we ensure your labels meet all federal standards and are positioned for successful market entry.
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Claims substantiation is a critical component of regulatory compliance in the oral care industry. We guide clients through the process of gathering scientific evidence to support product claims, helping to avoid enforcement actions from the FTC or NAD. Our attorneys are experienced in reviewing clinical studies, assessing the adequacy of substantiation, and advising on permissible language for advertising and promotional materials.
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In addition, we provide counsel on OTC monograph compliance and ingredient requirements, ensuring your products align with the latest FDA monographs and regulatory updates. From formula review to post-marketing surveillance, our firm delivers practical, actionable legal solutions that support your business objectives while safeguarding against regulatory pitfalls. Partner with us to confidently navigate the regulatory challenges unique to oral care products and maintain a competitive edge in a highly regulated industry.
Food & Drug Administration
The FDA provides regulatory services to ensure the safety, efficacy, and compliance of oral care products through product approvals, labeling requirements, ingredient oversight, and enforcement of federal standards
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Federal Trade Commission
The FTC enforces truth-in-advertising laws, ensuring that all oral care product claims are accurate, substantiated, and not misleading to protect consumers and maintain fair competition.
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National Advertising Division
The NAD provides independent self-regulation and dispute resolution services, reviewing the truthfulness and accuracy of advertising claims for oral care products to ensure fair competition and protect consumers
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Food & Drug Administration
The ADA provides clinical guidelines, oral health research, product evaluation programs, and advocacy to support dental professionals and promote public oral health.
OTC Monograph
OTC monograph compliance ensures that oral care products meet FDA standards for safety, effectiveness, labeling, and permitted ingredients, allowing them to be sold over the counter without a prescription.
Standards and Quality Compliance
Standards and quality compliance for oral care products involve meeting ISO guidelines, adhering to Good Manufacturing Practice (GMP), and following Good Clinical Practice (GCP) to ensure product safety, consistency, and regulatory approval