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Food Sensitivity Lab Test – Is it a medical device?

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EverlyWell‘s test measures your bodys immune response to 96 foods to help provide guidance on what foods may be the best to choose for an elimination diet. It measures IgG Reactivity to 96 foods.

A food reactivity is different than an immediately life-threatening food allergy. Food reactivity is a delayed immune response by the Immunoglobulin G (IgG) antibody, the most abundant circulating antibody in our immune system.

EverlyWell says their tests are

  • physician reviewed
  • use certified labs
  • easy-to-do at home with finger prick testing
  • can be paid with HSA/FSA payments

Walt’s answer:

This is not a medical device, although it comes close. They describe numerous health conditions that it helps with, although most of them are generic such as feeling tired or having joint pain. Some are specific, such as migraines. IgG Reactivity is a measurement that is not accepted as beneficial by many in health care. It does not have clinical tests to show efficacy. As with food supplements, the company can claim general health improvement, but they cannot claim specific disease treatment, unless it is a medical device. Since they give no specifics regarding migraines, I believe they have avoided the need to be a medical device. Because of their claims, this is a close call, and the FDA could send them a letter someday asking about their claims.

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