Recently the U.S. FDA has issued 12 warning letters and 5 online advisory letters to many foreign and domestic companies which were selling misbranded and unapproved supplements to treat Alzheimer’s and other diseases.
More than 58 products including dietary supplement were sold on websites and social media platforms, without been tested by the Food and Drug Administration.
The issue was published on FDA official, on 11 January 2019. According to the reports, the products which are not reviewed by the FDA might be ineffective or unsafe and mislead a person from getting proper treatment.
These products claim to prevent, treat serious diseases like Alzheimer, however, they are been sold in the market without the approval from FDA. Thus these products are violating the Federal Food Drug and Cosmetic Act.
They were sold in a variety of product types such as tablets, capsules, and oils. FDA demands a letter within 15 days from the companies stating how the contravention outlined in the agency can be corrected. Legal action or seizing of products will be taken if failed to do so.
The big names like Pure Nootropics, TEK Naturals, and Sovereign Laboratories, are rebuked for marketing their product by writing, ‘clinically shown to help diseases of the brain such as Alzheimer’s and even dementia.’
FDA encourages the costumes to be vigilant on the online website as well as stores which sell such products that claim to cure or treat these diseases without any approval. Also, all the health care professionals and consumers are advised to report any adverse reaction occurs due to the consumption of such products to the agency’s MedWatch program.
FDA Commissioner Scott Gottlieb, said, “Alzheimer’s is a challenging disease that, unfortunately, has no cure. 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.”
Additionally, he said, “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”.
In the past five years, the FDA has issued more than 40 warning letters to protect patients from fraud companies that illegally market medications to treat Alzheimer. According to the FDA reports, today there about 50,000 to 80,000 dietary supplements available in the market. Every third out of four American consumers take these supplement regularly.
FDA has assured the health of the public by monitoring the drugs, food, vaccine and other biological products that a person use. They are also responsible for regulating the national food supply, cosmetics, tobacco products, and all the products that radiate electronic waves.