Talk:Medical food

message: Was this originally a college paper? The format is highly non-encyclopedic. --Orange Mike 19:47, 21 September 2007 (UTC)
replies: text: this does not seem in the least like a college paper, Mike, and the format seems encyclopedic enough. A college paper would have much denser references, for one thing, more of an attempt at evaluation rather than description,  and wouldnt have illustrations. If it's a major FDA class of stuff it should have an article. DGG (talk) 22:22, 26 April 2008 (UTC)
thread_title:  Source of this article 

message: Moving here per WP:PRESERVE as this is almost all unsourced.   Per WP:BURDEN please do not restore without finding reliable sources per MEDRS, checking the content against them, and citing them. Jytdog (talk) 14:05, 16 May 2017 (UTC)
thread_title:  Unsourced 

message: In 2013 the FDA issued a draft guidance stating that it considered inborn errors of metabolism (IEMs) to be diseases or conditions that a medical food could be used to manage. IEMs was defined by FDA as including inherited biochemical disorders in which a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate. On the other hand, the agency pointedly noted that it did not consider pregnancy, diabetes, and essential nutrient deficiencies (e.g., scurvy, pellagra) to be diseases or conditions for which a medical food could be labeled and marketed because they do not present distinctive nutritional requirements. The final guidance was issued June 2016. Starting in 2013, after the draft guidance, the FDA started aggressively sending Warning Letters to companies claiming products were medical foods which the FDA declared were actually foods or dietary supplements making disallowed health claims.David notMD (talk) 20:50, 26 June 2017 (UTC)
replies: text: That raises an interesting point. Are any of the products listed in the article FDA-approved as medical foods for the advertised indications, or are they merely marketed in that manner without approval. If it's the latter, the list probably doesn't belong in the article, since the efficacy claims are primary-sourced and apparently not backed up by independent third-party sources. Rhode Island Red (talk) 01:36, 27 June 2017 (UTC)
replies: text: I deleted one example (Anoxa) because I knew the company had received a FDA Warning Letter. The others should be checked. The Medical Food classification is/was being used as a niche for dubious products because FDA pre-approval is not required (akin but different from dietary supplements). Simply put, a company could concoct a mix of nutrients and sell to consumers as a supplement, or call it a medical food and market it to doctors, to 'prescribe' to their patients. The latter allowed for much stronger health claims than allowed for supplements.David notMD (talk) 09:45, 27 June 2017 (UTC)
replies: text: That's what I suspected. All of the products mentioned are linked to the manufacturers' websites rather than to independent WP:MEDRS. Since the marketing claims are non-vetted and there is no reason to focus on this particular group of products, I deleted the section. Rhode Island Red (talk) 14:39, 27 June 2017 (UTC)
replies: text: I concur. It would be nice to have examples, the problem being that even for valid medical foods, would mean naming brands.David notMD (talk) 14:51, 27 June 2017 (UTC)
replies: text: Thanks for the cleanup and added content. Jytdog (talk) 15:35, 27 June 2017 (UTC)
thread_title:  FDA revised definition of 'medical foods'