14 June 2025... In This Issue of the Newsletter:
With RFK Jr and MAHA marketing dietary supplements completely changes...
Headline: FDA Reorganization
[1] Phosphatidylcholine Status
[2] New FDA NDIN Guidance Makes Filing Easier.
[3] FDA 'Healthy Food Claims'
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Headline: MAKE AMERICA HEALTHY AGAIN!
RFK Jr is reorganizing HHS, FDA and CDC
YOUR BOTTOM LINE WITH NOTICE!
Here is the Announcement:
https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html
The plan combines personnel cuts, centralization of functions, and consolidation of HHS divisions, including:
The current 82,000 full-time employees will be reduced to 62,000
28 divisions will be consolidated to 15
10 regional offices will become 5
Human Resources, Information Technology, Procurement, External Affairs, and Policy will be centralized.
Regarding FDA, CDC, NIH, and CMS:
FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.
Dramatic changes are coming to the dietary supplement marketplace. Make America Health Again is more than just a slogan. It is becoming the regulatory imperative! Here are some examples.
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[1] The Regulatory Status of Phosphatidylcholine
The Institute for Health Research [https://InHeRe.org]requested my professional analysis of the regulatory status of the dietary ingredient Phosphatidylcholine (PC) derived from a food source (soy). We start with the discovery of PC and then review some relevant literature.
"Phosphatidylcholine (PC), was one of the first biological amphiphiles to be discovered (Gobley, Citation1874). ... In the first half of the 20th century it became clear that PC formed a large and important part of membranes. This led to a considerable research effort to elucidate its biophysical properties (Chapman et al., Citation1977; Eliasz et al., Citation1976; Salsbury et al., Citation1970). ... leading to a widespread view that this lipid was a cellular building block..."
"... recent findings show that PC isoforms have pivotal roles in mammalian cells that are not directly connected to the role of PC as a major structural component of biological membranes. ... This invites speculation that the enzymes responsible for producing PCs are involved not only in directing the physical properties of mammalian membranes, but also some of the most fundamental metabolic activity of the organism."
https://www.tandfonline.com/doi/full/10.3109/09687688.2015.1066894
Furthermore, subsequent to its discovery in the 19th Century, and elucidation as a nutrient (from the 1950s through the 1990s) PC became utilized not as a ‘treatment’ for disease, but as part of the delivery systems for some medications that needed transport across membranes.
"In recent years Phosphatidylcholine has greatly impacted the drug delivery technology. The very first and most important advantage of phospholipid based vesicular system is the compatibility of phospholipids with membrane of human either internal membrane as well as skin (external membrane). ... Therefore the phospholipid based carrier systems are of considerable interest in this era. A number of drug delivery systems are based entirely on Phosphatidylcholine such as Liposome, Ethosome, Phytosome, Transferosomes, and Nanocochelates." https://ijpsr.com/bft-article/phosphatidylcholine-a-revolution-in-drug-delivery-technology/
The Dietary Health and Education Act of 1994 (DHSEA) protected certain ‘grandfathered’ nutrients from being regulated as prescription drugs. It is my opinion that PC qualifies under two of its clauses. The ingredient was sold to supplement the diet prior to June of 1994 and the ingredient is part of the human food supply and has not been chemically changed.
To be protected under DSHEA several other qualifications must be met.
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[2] New FDA Guidance Makes filing New Dietary Ingredient Notices [NDIN] Simpler
In the past, once the FDA allowed an NDI, it was allowed for all marketers. Now, however, the filing appears to grant a sort of 'monopoly' to the filing company. Note, for example, the second point on the FDA Guidance Summary:
"In some cases, manufacturers do not submit an NDIN because they believe the ingredient was covered by another NDIN that was not objected to by FDA. However, an NDIN for one manufacturer’s product does not eliminate the need for another manufacturer to submit an NDIN for their product."
Thus it might be possible to gain a stronger marketing position by filing NDINs to claim to market "FDA Filed Claims."
The FDA's Guidance Summary includes the following:
What common issues has FDA observed in the NDIN submission process?
1. The NDIN does not concern a dietary ingredient
The [DSHEA] dietary ingredient categories an NDI [New Dietary Ingredient] belongs to should be specified with an explanation of the basis for the conclusion [Note: an NDI is, by definition, not a dietary ingredient 'grandfathered' under DSHEA but it must be one of the categories in DSHEA: ingested vitamin, mineral, amino acid, herb, botanical, etc. not 'grandfathered']
2. The NDIN does not cover the broadest possible use of the NDI
In some cases, manufacturers do not submit an NDIN because they believe the ingredient was covered by another NDIN that was not objected to by FDA. However, an NDIN for one manufacturer’s product does not eliminate the need for another manufacturer to submit an NDIN for their product.
3. The NDIN does not include sufficient identity information
Notifications are more likely to be successful when FDA has a complete understanding of the identity of the NDI and how the scientific evidence supports it.
4. The NDIN includes irrelevant information to support the notifier’s conclusions
While the safety narrative and scientific evidence are crucial to a comprehensive NDIN, a notification should not contain irrelevant or extraneous information.
5. The notifier fails to submit proper references and/or copies of referenced articles or other underlying materials to support the safety of their NDI
https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process#videosfactsheets
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[3] FDA ‘Healthy Food’ Claims Guidance
RFK Jr is Reorganizing HHS, FDA and CDCNew Guidance Issued on Making Claims
Here is the FDA Announcement:
“Claims like ‘healthy’ on food labels can help consumers identify healthier food choices at a quick glance. Foods must meet specific criteria to use the ‘healthy’ nutrient content claim. The updated criteria for the claim replace outdated criteria for ‘healthy’ with criteria that are consistent with current nutrition science and Federal dietary guidance. For example, current U.S. dietary guidelines include a focus on the importance of healthy dietary patterns and the food groups that comprise them, the type of fat in the diet rather than the total amount of fat consumed, and the amount of sodium and added sugars in the diet. The updated criteria identify foods that help consumers build a healthy eating pattern. … To meet the updated criteria for the claim, a food product needs to [1] contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and [2] meet specific limits for added sugars, saturated fat and sodium.”
https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/use-healthy-claim-food-labeling
THE VITAMIN CONSULTANCY IS READY TO REVIEW YOUR CLAIMS WITH YOU TO DETERMINE WHICH ‘FDA ALLOWED’ HEALTHY CLAIMS YOU CAN ADVERTISE!
In addition to Healthy Food Claims, in my opinion, the revamped FDA will look more positively at Petitions for Qualified Health Claims. We should discuss which of the 24 existing approved Health Claims might apply to your products, or what possible Health Claims you could make that might be qualified for FDA ‘regulatory discretion.’
Reserve your review time now; only limited time available. Special Discount Hourly Rate for Vitamin Consultancy clients.
This special price offer covers Healthy Food Claims, Health Claims, NDIN and Normal Structure and Function Notices.
Email me at ralph.fucetola@gmail.com - Subject: CLAIMS
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