Top Claims 2019 (to date)
- Alzheimer's + dementia
- Anti-inflammatory + inflammation
- Cancer + tumor
- Erectile dysfunction + ejaculation + impotence + Viagra
- Arthritis + joint pain
- Fat + obesity
- Yeast infection + urinary tract
- Blood pressure + hypertension + heart attack + high cholesterol
- HIV + AIDS
- Liver + cirrhosis + hepatitis
- Insomnia + sleep
- Cold + flu
- Multiple sclerosis
- Macular degeneration + blindness + cataracts
- Kidney disease + kidney stones
- Hair loss + alopecia + balding
- Stroke (tied with gallstones)
How FDA Affects the Rankings
Federal action helps to both identify problematic trends and drive awareness about particular claims. For example, in February 2019, the FDA and FTC sent warning letters to 17 companies for illegally selling products claiming to treat Alzheimer’s disease. The products themselves vary greatly, though most, outside of their impermissible claims, were generally acceptable ingredients such as green tea, mushroom powder, and avocado oil.
“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s,” said then-FDA Commissioner Scott Gottlieb. “Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products.”
While the FDA’s investigation may be a reflection of an increase in products claiming to treat Alzheimer’s, the administration’s action to shine a spotlight on these claims could help to reduce them for 2020 and beyond. In past years, the FDA has taken similar action against companies and dietary supplements making impermissible claims for the treatment of serious conditions such as cancer and opioid addiction. LegitScript has seen these categories drop significantly in successive years.
So far this year, the FDA has issued 249 warning letters, still far short of 2018’s 419 and 2017’s 512. Of the 246 warning letters, at least 30 were related to misbranded products, primarily in the context of impermissible marketing claims.
Posted by David Khalaf