Is Aging a Disease? Regulation and Aging as an Indication

Why the question matters

Regulators approve medicines for diseases and conditions. If aging is not one of those, a product cannot be approved "for aging," and a seller cannot lawfully promise to treat it. The debate is partly about words and partly about how drug development, insurance and marketing work. This page reports what we could read from regulators and from published expert statements, and where we found nothing.

Evidence labels used here: approved medicine, established, insufficient evidence, preclinical (cells/animals only) and marketing claim. Where we looked and found nothing usable we write "Proper evidence not found."

What the WHO classification says

The World Health Organization (WHO) publishes the International Classification of Diseases (ICD), a common language for recording and monitoring diseases and health conditions. Its FAQ on "old age" says the ICD is not classifying old age as a disease. The relevant category is used for quality control and to code unclear statements by physicians on death certificates or medical records. [1]

WHO also says the category label was changed in ICD-11 to "Ageing associated decline in intrinsic capacity," and that the term "old age" is kept for indexing only, because physicians use it in records. [1] A 2022 commentary in The Lancet Healthy Longevity is titled "How 'old age' was withdrawn as a diagnosis from ICD-11." [2]

What drug labels list

We read two US labels used in aging research. Neither lists aging.

• Metformin: indicated as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 and older with type 2 diabetes. [3]
• Sirolimus (rapamycin): indicated to prevent organ rejection in kidney transplant recipients aged 13 and older and to treat lymphangioleiomyomatosis. [4]

Approved medicines are reviewed for named conditions. The FDA says that once a drug is approved, health care providers generally may prescribe it for an unapproved use when they judge it medically appropriate, but FDA has not determined that the drug is safe and effective for that use. [5] See off-label prescribing for longevity.

Proper evidence not found for an FDA statement that defines aging itself as a disease or approves an aging indication. We checked FDA's surrogate-endpoint, off-label, supplement and anti-aging consumer pages and the two labels above. If you need the current regulatory position, ask the FDA or read its guidance directly.

What dietary supplement law adds

FDA says a product sold as a dietary supplement and represented to treat, prevent or cure a specific disease is a drug. [6] Structure/function claims, which describe effects on the body's normal structure or function, are allowed with a required disclaimer that FDA has not evaluated the statement. [6] FDA also says that, despite claims about pills or treatments that lead to endless youth, no treatment has been proven to slow or reverse the aging process. [7] More in anti-aging products and regulation.

The scientific debate

Some researchers argue for a path in which aging-related decline could be targeted directly. A 2022 paper in Aging Cell proposed a standard process for evaluating FDA-approved medicines for their potential to target aging, and described a "TAME-like" next study (Targeting Aging with Metformin). [8] A 2016 summary in Cell Metabolism described metformin as the drug to be tested in the TAME trial, as an initial step toward developing better ones. [9] We did not verify the current enrollment or results of TAME; see aging clinical trials.

Others work on definitions. In 2025 a consensus meeting of 150 experts, held in Cardiff in 2024, agreed three criteria for an "ageing-related pathology, disease or syndrome": it develops or progresses with increasing age, it contributes to functional decline or susceptibility to it, and it is evidenced by studies in humans. Each criterion needed at least 70 percent agreement. [10] Note that this defines age-related diseases, not aging as a whole.

A 2021 critical review concluded that the evidence that metformin extends human lifespan remains controversial. [11] That is why the regulatory question and the evidence question are separate: even if the label problem were solved, the benefit would still need to be shown.

What this means for readers

• A claim to "treat aging" is a marketing claim, not a regulated medical indication.
• Age-related diseases, such as osteoporosis or type 2 diabetes, are real conditions with approved treatments. See healthy aging for practical guidance and surrogate endpoints for why proof is hard.
• Do not start or stop any medicine because of this debate. Talk with your prescriber.