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RUTF FDA Approved

This question was posted the Prevention and treatment of severe acute malnutrition forum area and has 7 replies. You can also reply via email – be sure to leave the subject unchanged.

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Suhail

Normal user

10 Nov 2015, 17:09

Is Plumpy Nut RUTF approved by FDA? Can anyone forward me the link.

Wisdom

Normal user

13 Nov 2015, 11:10

Greetings,

RUTF is listed as a commodity in the USAID factsheet at, http://www.usaid.gov/what-we-do/agriculture-and-food-security/food-assistance/resources/ready-use-therapeutic-food;

I hope this gives some insights.

Anonymous 94

Normal user

13 Nov 2015, 12:18

Suhail, by FDA do you mean the American Food & Drug Administration? I'm not American and don't work in the US, but I would assume that it would only need to be approved by the FDA if it was used in the US. If I'm wrong, someone please correct me.

Maybe Edesia would be able to answer your question as they produce it there. http://www.edesiaglobal.org/

Suhail

Normal user

16 Nov 2015, 12:31

Thanks dear Wisdom and Ellen Boldon for your reply. Yes, i mean the US FDA approval of Plumpy Nut RUTF. I posted this question here because may be any senior member knows about it.

Judy Canahuati

Retired

Normal user

16 Nov 2015, 14:11

In the US there is a complicated system for approving foods. There is a Federal Acquisition Regulation (FAR), which might be considered as equivalent to Codex. All of the components of an RUTF would be in that FAR system (DSM, peanuts, oil, etc.). In general, commerce in drugs is under FDA responsibility and food under USDA responsibility. At USAID, we treat RUTF as a food, not a drug. The specifications for generic RUTF are listed on the USDA commodity requirements document website http://www.fsa.usda.gov/Assets/USDA-FSA-Public/usdafiles/Comm-Operations/pdf/rutf2.pdf, as are the requirements for RUSF. USAID has initiated monitoring of manufacturers and food safety in line with the Food Safety Modernization Act which requires a HAACP audit and plans and records of environmental monitoring. These specifications are being updated to align with the new UNICEF specifications. Inspections of manufacturing plants are carried out by USDA Agricultural Marketing System inspectors, who do much of the food safety inspections in the US. USAID works very closely with USDA to monitor the quality and safety of the product.

Suhail

Normal user

16 Nov 2015, 15:18

Thanks Judy Canahuati for clarification. I assumed that RUTF is medicine due to its usage in clinical indication (SAM). It has also a specific composition of micro nutrients like other nutritional supplements. In research, specially in trials we need to register the trials in clinical trials.gov. Online procedure needs the information that is RUTF approved by the FDA which is being used as an intervention in the area.
Another question that has Plumpy Nut RUTF any chance of toxicity in the population, if it is taken more then a recommended dose?

Judy Canahuati

Retired

Normal user

16 Nov 2015, 17:28

Suhail,

Good question and one I think that we don't have definitive answers for. However, I think that you would need to look at Upper limits for the particular age group in question ss well as for the particular micronutrient. If you look at the latest version of Nut Val you can see the calculations for vitamins and some of the minerals in several versions of RUTF. Possible toxicity is pretty specific to a particular micronutrient and generally over time. In the US for example, iron toxicity has occurred in children from consumption of mother's iron (ferrous sulfate) tablets which have about 20% elemental iron. Toxicity has occurred with ingestion of about 60mg/kg of iron. A child would need to consume a tremendous amount of RUTF to get to that level of iron. Two sachets of RUTF, for example, have about 24mg of iron. There also seems to be a difference in the way the body absorbs micronutrients when they are in concentrated tablet form and when they are embedded in a food matrix but we probably need to learn a great deal more about that.

The amount of time a child would consume RUTF is relatively short. Also, we don't really have a great deal of information about what "needs" are when a child is severely acutely malnourished as this has a great deal to do with absorption and absorption is probably severely compromised in the SAM child and that is probably why some of the quantities of the micronutrients (eg Vitamin A) are so much higher than "normal". If you look at the WHO technical note on feeding of moderately acutely malnourished, the guidance (http://apps.who.int/iris/bitstream/10665/75836/1/9789241504423_eng.pdf) sets up a range per 1000 calories for macro and micronutrients. One of the micronutrients that people "worry" about is Vitamin A and the range is 2000-3000 mcg per 1000 calories. 1000 calories corresponds to 2 sachets and in general young children might consume between 2-3 sachets in a day in addition to breastmilk. If you triangulate the two documents, an infant/young child would need to get to 3 sachets per day before getting to the 3000mcg upper end of the range for Vitamin A.

Thinking about the realities of feeding a 14-month old 3 sachets of RUTF a day, it seems highly unlikely that s/he would consume enough Vitamin A to be worrisome. There is some good guidance for use of micronutrients in the Codex Guideline for formulated complementary foods for older infants and young children

"6.6.1.3 If the dietary intake data for the target population is not available, the vitamins and minerals listed in the Table in the Annex to these Guidelines can be used as a reference for the selection of particular vitamins and minerals and their amounts for addition to a Formulated Complementary Food.
6.6.2 National authorities should ensure that the total micronutrient intake from the Formulated Complementary Foods, local diet (including breastmilk and/or breastmilk substitutes) and other sources do not regularly exceed recommended upper levels of micronutrient intake for older infants and young children."

I think that the key would be "regularly exceed" in this guidance. RUTF is provided for a specific purpose for a fairly defined period that is relatively short-term. We still don't understand enough about what the actual micronutrient status is of infants and young children at the end of treatment -- which means that we don't know that much about how recovering SAM kids are actually aborbing these micronutrients.

My hypothesis would be that appetite would probably be key to consumption of the micronutrients and that it would be difficult to "make" an older infant consume enough so that toxicity might be an issue. If you've ever eaten a packet of RUSF or RUTF, you know they are pretty filling, even for an adult-- much less an infant with much smaller stomach capacity at any one "meal" --who might also be breastfeeding.

Don't know if this helps -- but the sum of this is that, while not an "easy" question, the chances of over consumption to the point of toxicity, provided that food safety and quality standards are followed in the process of the food -- is probably minimal.

Suhail

Normal user

16 Nov 2015, 18:59

Thanks Judy Canahuati. Really it was a new question for me, i don't know how much is this applicable in the field. But i have learnt from your detailed reply.

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