VeganMed, Inc.
Jul 14, 2023
Foley has officially filed a citizen petition on behalf of VeganMed, calling on the FDA to update and clarify labeling regulations for animal-derived products.
Foley & Lardner LLP, representing VeganMed, Inc., has filed a Citizen Petition with the Food and Drug Administration (FDA) calling for a revision of existing regulations and policies pertaining to the labeling of animal-derived ingredients in drugs and dietary supplements. The petition seeks to ensure transparency and provide consumers with accurate information regarding the presence of animal-derived ingredients in these products.
VeganMed, Inc., an advocate for animal-free alternatives, spearheads this endeavor as the petitioner, requesting the Commissioner of Food and Drugs to implement crucial changes:
Require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal-derived.
Encourage manufacturers to replace animal-derived ingredients with plant-based and/or synthetic alternatives when viable options are available.
Confirm that labeling of drugs and dietary supplements may include a certification symbol denoting the absence of animal-derived ingredients.
The basis for this petition stems from concerns regarding the current lack of transparency and the challenges faced by consumers with health-related, dietary, religious, or moral restrictions. Many individuals, including those with alpha-gal syndrome (AGS), allergies, religious dietary requirements, and ethical concerns, are unable to effectively identify and avoid products containing animal-derived ingredients. The petition emphasizes that approximately 3% of the U.S. population may be affected by AGS, a condition triggered by a sugar molecule found in mammalian products, and that in a recent noteworthy survey of 559 AGS patients, 3 out 4 respondents said they had reacted to animal-derived ingredients in medications. Furthermore, it highlights that an estimated 10% of Americans consider themselves vegan or vegetarian, and specific religious groups also adhere to dietary restrictions. These consumers deserve access to accurate information to make informed choices about the products they use.
Currently, drug and dietary supplement manufacturers are not required to disclose whether their products contain animal-derived ingredients. This lack of labeling transparency poses challenges for consumers and healthcare professionals alike. It forces consumers to rely on unreliable or outdated resources for information and places a burden on them to contact manufacturers directly. Healthcare professionals also struggle to obtain reliable information about the origin of ingredients used in drug products, making it difficult to address patients' concerns. By mandating disclosure of animal-derived ingredients, the FDA can empower consumers and healthcare professionals to make better-informed decisions about their health.
The petition also highlights the need for manufacturers to replace animal-derived ingredients with plant-based and/or synthetic alternatives whenever viable alternatives exist. This change would facilitate access to essential treatments for consumers with health or dietary restrictions, religious convictions, or moral beliefs. Moreover, it would promote diversity and inclusion in clinical trials and improve patient safety by minimizing adverse reactions and medication non-adherence.
In a bid to provide unequivocal clarity, the petition also calls for the inclusion of an accurate and truthful certification symbol or statement on drug and dietary supplement labels, signifying products that are entirely free from animal-derived ingredients. Such a visual cue would alleviate the arduous task faced by consumers in deciphering complex ingredient lists and provide a reliable marker for individuals seeking animal-free options.
Foley & Lardner LLP, through partner David L. Rosen, B.S. Pharm., J.D., submitted the Citizen Petition to the FDA on behalf of VeganMed, Inc.
For further information, please contact: sachin@veganmed.org
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About VeganMed, Inc.:
VeganMed, Inc. is a prominent advocate for transparent labeling and the promotion of animal-free alternatives in the healthcare industry. The company is dedicated to ensuring access to vegan-friendly drugs and dietary supplements for individuals with dietary restrictions, ethical concerns, and health-related needs.