FDA Update

Not All Supplements are Created Equal…

Amazon Faces a Lawsuit Over Mislabeled Dietary Supplements

A class action lawsuit has been filed against Amazon, alleging that the company sells dietary supplements with misleading labels and without proper FDA disclaimers, essentially marketing them as drugs without FDA approval. The lawsuit claims that Amazon promotes supplements with health-related claims without the necessary disclaimers, violating both federal and California consumer protection laws. Amazon is also facing scrutiny for potentially selling counterfeit supplements and failing to properly vet third-party sellers.

Here is a breakdown of the Amazon supplement safety situation:

1. Misleading Labeling and Health Claims:

• The lawsuit argues that Amazon markets supplements with unsubstantiated health claims, such as claims about supporting joint, heart, brain, hair, teeth, and immune health, without the required FDA disclaimers.
• These disclaimers are crucial to distinguish between supplements and drugs, as supplements are not reviewed or approved by the FDA for their health claims.
• According to Bloomberg Law News, the judge in the case stated that the plaintiffs adequately showed that Amazon violated California consumer protection laws by selling supplements with broad, unverified health claims without proper disclaimers.

2. Counterfeit and Unapproved Supplements:

• The lawsuit alleges that Amazon is selling supplements that are essentially illegal drugs because they lack the necessary FDA review and approval.
• There have been previous concerns about counterfeit supplements on Amazon, particularly those from third-party sellers.
• Amazon has faced warnings from the FDA for selling supplements with undeclared ingredients.

3. Legal Challenges and Implications:

• The lawsuit has been allowed to proceed, with the judge rejecting Amazon’s attempt to dismiss the case.
• The judge found that the plaintiffs had standing to sue, even if they did not purchase the specific supplements mentioned in the lawsuit, because they alleged a systemic marketing practice by Amazon.
• According to Law360, the case highlights the legal complexities surrounding dietary supplements and the potential risks of buying them online, especially from platforms like Amazon.
• The case is ongoing, and the outcome could have significant implications for Amazon’s policies on selling supplements and its liability for third-party sellers.

4. Amazon’s Response and Policy Changes:

• Amazon has updated its dietary supplement policy to require third-party testing to ensure products meet specific safety standards.
• The updated policy requires products to be manufactured in facilities compliant with FDA regulations, free of contaminants, and accurately labeled.
• Amazon also requires third-party verification through a Testing, Inspection, and Certification (TIC) organization for dietary supplement products.

In conclusion: This lawsuit underscores the importance of carefully vetting supplements before purchasing them online, especially from platforms like Amazon. While Amazon has implemented new policies to address safety concerns, the ongoing legal battle highlights the potential risks associated with the platform’s handling of dietary supplements.

Questions?

For more information on Amazon and supplement safety please email us at: info@mdiconsultants.com and ref: Amazon and supplement safety.

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