A: The ADINA Act is a labeling transparency bill—not a manufacturing or reformulation mandate. Because it builds on existing labeling practices and leverages existing FDA structures, we do not anticipate significant costs to the federal budget. Cost and implementation logistics will be shaped in collaboration with industry during the markup process.

A: No. The bill does not require reformulation or removal of allergens—only transparent labeling in plain language, similar to what’s already required for foods.

A: No. The ADINA Act does not require the disclosure of proprietary formulas, manufacturing processes, or trade secrets. It simply mandates that if a medication contains any of the top food allergens or gluten-containing grains, that information be disclosed clearly in plain language—just like food labeling laws. Only the presence of known allergens needs to be stated, not how or why they’re used.

A: It would likely fall under the FDA’s oversight, utilizing existing regulatory structures. However, the exact implementation would take guidance from industry experts, stakeholders, and regulatory agencies to determine the most practical and effective path forward.

A: Our goal is to get the bill to markup, where Congressional committees can engage experts, stakeholders, and agencies to help refine and shape the most effective version of the bill. The ADINA Act is designed with broad, flexible language to ensure the FDA, pharmaceutical industry, and allergy experts can inform the best path forward. Allergen transparency is the priority—industry expertise will help define the ‘how.’ At its core, the goal is simple: ensure 24/7 consumer access to clear, plain language labeling for all top food allergens and gluten—such as ‘Contains: Milk’—so that individuals can make safe and informed decisions at the point of care.

A: The ADINA Act requires clear labeling of all top food allergens—milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame—as well as gluten-containing grains.

A: Two years from enactment to allow companies to adapt labeling and ensure compliance.

A: No. Many inactive ingredients are either not disclosed at all or listed under generalized terms that do not reveal their source. For example, a pharmacist might see “starch” on a label, but won’t know whether it’s derived from wheat, corn, or another source unless it’s clearly labeled. Even product inserts often omit this level of detail, leaving patients at risk when allergen information isn’t plainly disclosed.

A: Unfortunately, no. While ingredients may appear on packaging or inserts, they’re often listed under complex, scientific names—like “sodium caseinate” or “pregelatinized starch”—that don’t indicate their allergen source. These names don’t help the average consumer or pharmacist determine whether a substance is derived from milk, wheat, soy, or another allergen. Without clear, plain language like “Contains: Milk,” families are left to guess and hope—often in urgent or life-threatening situations. This confusion can lead people to delay or completely avoid treatment altogether, out of fear that a medication might trigger a reaction.