Talk:Medical food

Wiki Education Foundation-supported course assignment

This article was the subject of a Wiki Education Foundation-supported course assignment, between 27 August 2019 and 18 December 2019. Further details are available on the course page. Student editor(s): Kellyyyyy123.

Above undated message substituted from Template:Dashboard.wikiedu.org assignment by PrimeBOT (talk) 03:46, 17 January 2022 (UTC)

Source of this article

Was this originally a college paper? The format is highly non-encyclopedic. --Orange Mike 19:47, 21 September 2007 (UTC)

Efficas Care is not a medical food as the company that manufactures this product has received a warning letter from the FDA dated September 28, 2007 stating that the product failed the definition of medical food, and reference to this product should be removed from this discussion. —Preceding unsigned comment added by 165.236.71.234 (talk) 19:27, 23 April 2008 (UTC)

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)

Unsourced

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)

from WP:LEAD

Medical foods are distinct from the broader category of foods for special dietary use and from traditional foods that bear a health claim. In order to be considered a medical food the product must, at a minimum:

• be a food for oral ingestion or tube feeding (nasogastric tube)
• be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements, and
• be intended to be used under medical supervision.

Medical foods can be classified into the following categories:

• Nutritionally complete formulas
• Nutritionally incomplete formulas
• Formulas for metabolic disorders
• Oral rehydration products

Examples

Allergic conditions

Medical foods for management of allergic conditions may contain both gamma-linolenic acid (GLA), a short chain omega-6 fatty acid primarily sourced from the seeds of the borage plant, and eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid sourced from fish. These fatty acids help to inhibit the production of leukotrienes in the system. Sufficient quantities of GLA and EPA necessary for reduction of leukotrienes cannot be obtained from a normal diet. Leukotrienes are inflammatory molecules produced by immune cells (neutrophils, basophils, mast cells, macrophages and eosinophils) in the body. They are involved in the inflammatory response and cause the narrowing of the airways, increased mucus production and tissue swelling associated with both allergies and asthma. In order to control allergic symptoms, research shows that it helps to inhibit the production of leukotrienes in the body.

Diabetes mellitus

Medical foods for management of diabetes mellitus generally contain slowly digested carbohydrates, which helps minimize peaks in blood sugar. Consistent maintenance of optimal blood sugar levels (avoiding highs and lows) over time can help reduce the complications of diabetes.

Gastrointestinal tract impairment

Medical foods for management of gastrointestinal tract (GI tract) impairment provide an amino acid-based diet in its most easily digestible (elemental) form to aid in poor nutrient absorption due to digestive disease, malabsorption, severe food allergies, or other conditions in which the GI tract is severely compromised.

Metabolic stress

Medical foods for management of metabolically stressed patients provide supplemental glutamine to nourish the GI tract and restore glutamine while a patient is in a stressed, catabolic state.

'Depression Medical foods containing L-methylfolate are used in conjunction with a serotonin reuptake inhibitor to treat depression.

References

-- Jytdog (talk) 14:05, 16 May 2017 (UTC)

According to FDA guidance (2016) the medical foods classification does not apply to health conditions such as Alzheimer's disease, diabetes mellitus, allergies.... This does not preclude making and selling functional foods or dietary supplements to these health states, but those are restricted as to what is allowed for health claims in a way that medical foods are not.David notMD (talk) 09:37, 27 June 2017 (UTC)

FDA revised definition of 'medical foods'

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)

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[1] 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)

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)

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)

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)

Thanks for the cleanup and added content. Jytdog (talk) 15:35, 27 June 2017 (UTC)