FDA Warning: Unapproved Eye Product Marketing Alert

Michael S on September 12, 2023

FDA Warns Against Unapproved Eye Products 

The United States Food and Drug Administration (FDA) has formally notified eight entities through warning letters, citing their involvement in the production or distribution of ophthalmic medications that have not received FDA approval, thus contravening federal regulations. This action is a continuation of the FDA’s commitment to safeguarding the public from ophthalmic products that may pose health risks. 

Key Points:  

  • FDA Issued Warning Letters to Eight Companies: The U.S. Food and Drug Administration took action against eight companies for manufacturing or marketing unapproved ophthalmic drugs, which is a violation of federal law. 
  • Concern Over Unapproved Eye Products: The eye products in question were being marketed to treat conditions like conjunctivitis, cataracts, glaucoma, among others. The FDA raised concerns about the legality and safety of these products. 
  • Risks of Using These Products: The FDA highlighted the risks associated with using these unapproved eye products, including the potential for harm as these drugs bypass some of the body’s natural defenses. Products containing silver, for example, were noted for the risk of causing argyria, a condition where skin and body tissues, including in the eye, turn gray or blue gray. 
  • FDA’s Commitment to Drug Safety: The FDA emphasized its commitment to ensuring the safety and efficacy of medications available in the U.S. The agency is dedicated to identifying and addressing illegal marketing and quality lapses in drug standards. 
  • Potential Legal Actions and Consumer Advisory: The FDA warned of potential legal actions against the companies if they fail to comply with regulations, including product seizure or court orders. Additionally, consumers using these products were advised to consult healthcare professionals, and the FDA encouraged the reporting of any adverse reactions. 

The medications in question, featured in the warning letters, are being marketed for the treatment of various eye-related ailments, including conjunctivitis, cataracts, and glaucoma, among others. Additionally, the FDA has identified concerns regarding the sterility and quality of these products. 

A significant concern of the FDA pertains to the risk associated with these unauthorized ophthalmic products. Medications applied to the eyes can circumvent some of the body’s inherent protective mechanisms. Notably, several of these products contain silver (referred to as silver sulfate, silver sulphate, or argentum). Prolonged exposure to silver in medications can lead to a permanent discoloration of the skin and other body tissues, including the eyes, a condition known as argyria. Furthermore, the use of these unapproved drugs might result in consumers postponing or discontinuing medically approved treatments that have been verified for safety and efficacy by the FDA. 

Jill Furman, the Director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s dedication to ensuring the safety, efficacy, and quality of medications available to the American public. The FDA’s efforts include identifying and addressing violations related to the marketing of unapproved drugs and lapses in quality standards. The FDA is resolute in its mission to investigate and regulate the market to prevent the distribution of potentially harmful eye products. 

The entities that have received these warning letters include: 

  • Boiron Inc. 
  • CVS Health 
  • DR Vitamin Solutions 
  • Natural Ophthalmics, Inc.
  • OcluMed LLC
  • Similasan AG/Similasan USA
  • TRP Company, Inc.
  • Walgreens Boots Alliance, Inc. 

The FDA advises consumers currently using any of the implicated eye products to consult with their healthcare professionals. The agency also encourages the reporting of any adverse reactions to its MedWatch program. 

The cited companies are required to respond within 15 days from receipt of the warning letters, outlining their corrective actions. Non-compliance may result in further legal action by the FDA, including product seizures or court orders to cease production and distribution of these unauthorized products. Moreover, some of these companies are now subject to import alerts to prevent their products from entering the U.S. market. 

The FDA continues to actively investigate this matter and may initiate additional regulatory or enforcement measures as necessary. 

As an integral part of the U.S. Department of Health and Human Services, the FDA upholds public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use, along with medical devices. The agency also regulates the national food supply, cosmetics, dietary supplements, products emitting electronic radiation, and tobacco products. 

 

Navigating the Legal Tides: Understanding the Landmark AFFF/PFAS Water District Settlement

Michael S on July 26, 2023

Unpacking the Monumental AFFF/PFAS Water District Settlements

In recent legal developments, the potential settlements involving AFFF (aqueous film-forming foam) and PFAS (perfluoroalkyl and polyfluoroalkyl substances) have marked a significant turn in environmental and public health litigation. With DuPont, Chemours, and 3M reaching monumental, proposed class action settlements, the legal implications for public water systems and potential personal injury claimants are substantial. Below are key points and a closer discussion on the legal ramifications of these developments:

  

Key Points: 

  • Dupont and Chemours proposed a class action settlement for $1.185 billion affecting around 7,000 public water systems. 
  • 3M announced a settlement with a net present value of $10.3 to $12.5 billion over 13 years for over 6,000 water systems. 
  • Judge Gergel acknowledged these as potentially the largest drinking water settlements in history. 
  • Settlements present a significant step forward for AFFF and PFAS personal injury claimants. 
  • Future settlement negotiations may extend to a broader group of victims with PFAS-related diseases. 

  

Legal Implications for Public Water Systems 

The legal environment for entities involved in the management of public water systems has been significantly altered due to the proposed settlements announced by DuPont, Chemours, and 3M. These agreements represent not just financial compensation for the alleged contamination of drinking water but also signal a shift in how companies address massive environmental tort claims. 

  

DuPont and Chemours Settlement 

The settlement proposed by DuPont and Chemours offers a substantial sum, potentially benefiting thousands of public water systems. While the amount is notable, the allocation of these funds across the various districts remains unclear. Moreover, the settlements are not without their limitations; for instance, they exclude state attorneys general and other entity plaintiffs. Despite these constraints, Judge Gergel has pointed out that the standard for preliminary approval is relatively low, suggesting that the process may progress swiftly, with a fairness hearing expected to occur by late 2023[^1]. 

  

3M Settlement 

Similarly, 3M’s proposed settlement introduces a complex funding structure to be disbursed over more than a decade. This prolonged payment period adds a layer of complexity to the financial management and planning for public water systems seeking remediation and preventative measures against PFAS contamination[^2]. 

  

Potential Impact on Individual Entity Litigation 

Judge Gergel’s indication that the settlements could have advantages over continuing individual litigation reflects a broader legal tendency to favor collective resolution in mass tort cases. This preference is underscored by the potential for quicker resolution and the distribution of settlement funds to address pressing contamination concerns[^3]. 

  

Implications for Personal Injury Claimants 

The settlements carve a path for personal injury claimants within the MDL (multidistrict litigation) to move forward, potentially expediting their claims. It also allows companies like 3M, DuPont, and Chemours to better manage market pressures by quantifying liabilities, potentially improving their financial narratives[^4]. 

  

The settlements may also open avenues for future negotiations regarding personal injury claimants, particularly those with conditions supported by studies linking PFAS exposure to certain diseases. This suggests a legal landscape that is becoming more receptive to substantial compensation for victims of environmental contamination[^5]. 

  

Looking Forward 

As these proposed settlements move toward preliminary approval, the legal community, particularly those representing personal injury claimants, is closely monitoring court filings and hearings for additional details that may influence the litigation’s trajectory. 

  

Conclusion 

These settlements are groundbreaking not only in their scale but also in their potential to set precedents for environmental litigation and corporate accountability. While the legal process is far from over, the proposed resolutions reflect a notable shift in addressing the liabilities associated with PFAS contamination and the rights of those affected.