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Lactation Information and Discussion <[log in to unmask]>
Date:
Sat, 10 Jul 2004 14:43:07 -0400
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>>>but I found a company called Solus out of Virgina Beach, Virginia that
works with government, university and corporate experimental and
computational
facilities.

[snip]

Is this the company included as part of the International Formula Council?
Can someone on this list help me out here?<<<

Valerie,

You probably already realize by now that Solus Products, LLC is in
Indianapolis, Indiana.

>>>I did find a letter in the FDA dockets written by this company on July
10, 2004 in regard to docket 95N-0309<<<

The letter from Dennis Heuring, PhD, Managing Partner of Solus Products, LLC
to the FDA was dated August 26, 2003. Here's the link to a copy of the
original letter:


http://www.fda.gov/ohrms/dockets/dailys/03/Sept03/090503/95n-0309-c000022-01
-vol9.pdf

I think the link you provided to the letter gives the date the web page is
accessed, not the date of the letter. Here's the letter in its entirety for
those not able to view PDF pages:

>>>VIA OVERNIGHT MAIL

Dockets Management Branch, HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

RE:     DOCKET 95N-0309
CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY
FACTORS, NOTIFICATION REQUIREMENTS AND RECORDS AND REPORTS, FOR THE
PRODUCTION OF INFANT FORMULA

Dear Sir or Madam:

By this letter Solus Products confirms its endorsement of the comments
submitted to this docket by the International Formula Council ("IFC").

We believe these regulations are of great importance. An extraordinary
amount of effort was expended by all members of the infant formula industry
in the process of reviewing the proposed regulations and reaching the
industry-wide consensus that is reflected in the IFC comments. These
comments are the result of a detailed review of the proposed regulations by
members of industry with long experience and a high level of expertise in
the design, testing, and manufacture of infant formulas. The commitment of
this amount of time and of this level of expertise is evidence of the
importance that the industry places upon these regulations.

Like FDA, industry wants to ensure the continuing integrity and adequacy of
all U.S. infant formulas. The regulatory review process conducted by the
industry was constructive, and underscored to all of us the value of
communication to accurately determining the effectiveness and impact of a
proposed regulation. We hope that this effort can be continued in dialogue
with FDA in a joint effort to craft final regulations that are clear,
constructive, and effective.


Yours truly,

Dennis L. Heuring, Ph.D.
Managing Partner
Solus Products, LLC<<<

Found another name associated with Solus Products, LLC:

Dr. Wei Bidlack, Agriculture
Solus Products, LLC
Protein Efficiency Ration Trial
$4,500


Solus Products, LLC is also listed as one of the private sector
donor/sponsors "who have supported nutrition and food science research and
sponsored projects" of the Agricultural Research Initiative (ARI) at
California State Polytechnic University, Ponoma:

http://www.agresearchpomona.org/ari/nutrition.asp


I also did a search on Solus and Indianapolis, Indiana (per the address
given in the letterhead of the FDA letter) and found a company listed as
Solus Food Stores at this link:

http://www.naidirect.com/market_research/html/501211_marketrep.aspx

I wonder if there's any connection between the two?


Here's a couple of links to the International Formula Council's web site
where Solus Products is mentioned:

http://www.infantformula.org/aboutus.html

>>>About Us
INTERNATIONAL FORMULA COUNCIL FACT SHEET

The International Formula Council (IFC) is an international association of
manufacturers and marketers of formulated nutrition products (e.g., infant
formulas and adult nutritionals) whose members are predominantly based in
North America. It was formed in 1998 through the consolidation of the Infant
Formula Council (founded in 1970) and the Enteral Nutrition Council (founded
in 1983).

IFC members support the American Academy of Pediatrics' position that
breastfeeding is the preferred method of feeding infants, and if a mother
cannot or chooses not to breastfeed, or discontinues breastfeeding prior to
1 year or chooses to supplement -- an iron-fortified infant formula is
recommended. IFC members are committed to assuring that the highest quality
product reaches the consumer. They further recognize their special
obligation to consumers to provide products that are both safe and
nutritious, and which can be used with utmost confidence.

Members are: Mead Johnson Nutritionals; Nestle USA, Inc., Nutrition
Division; Ross Products Division, Abbott Laboratories; Solus Products; and
Wyeth Nutrition.

April 2004<<<


http://www.infantformula.org/newsroom_060404_1.html

>>>News Room
For Immediate Release
June 10, 2004  Contact: Mardi Mountford, MPH
Robert C. Gelardi
(404) 252-3663

In response to questions about the Office on Women's Health / Dept. of
Health and Human Services (HHS) campaign to promote breastfeeding, the
International Formula Council has developed the following statement:

"The International Formula Council (IFC)* and each of its members strongly
support the promotion of breastfeeding and are pleased that, through a
concerted effort by the health community, government and industry, recorded
breastfeeding rates in the U.S. are the highest they have been in over 30
years.

"The IFC and its member companies support positive, accurate promotion of
breastfeeding including additional efforts to foster high breastfeeding
rates.

"The IFC remains concerned that the images of visibly pregnant women
log-rolling and bull-riding in the HHS ads are unnecessarily alarming and
misrepresentative; however, we are encouraged that the campaign content
reflects the latest science.

"The IFC underscores the statement made by the U.S. government's Department
of Health and Human Services (HHS): "HHS strongly recommends and encourages
women to breastfeed exclusively for six months. But it understands that
there are mothers who are unable to breastfeed or shouldn't breastfeed.
Infant formula is safe and nutritious for those women who are not able to
breastfeed. In fact, the federal government is a large distributor of infant
formula through various programs, such as the Women, Infants, and Children
program." Further, the IFC supports the American Academy of Pediatrics'
position, which states that for those mothers who cannot or choose not to
breastfeed, iron-fortified infant formula is recommended.

"We strongly encourage HHS to carefully monitor reactions to the ads and
measure the impact on mothers. Many barriers to breastfeeding exist that
prevent mothers from exclusively breastfeeding their infant for six months,
and the feeding decision itself can be highly emotional and personal. The
government, the American Academy of Pediatrics and the infant formula
industry support breastfeeding as the preferred method of infant feeding,
and also encourage parents to consult with their health care professional in
making this decision.

"Research shows that mothers know breastfeeding is best, and that positive
support is what works to increase breastfeeding. The IFC and infant formula
companies are committed to working with HHS and other interested parties to
develop and communicate positive, factual information about the importance
of breastfeeding, as well as address critically important issues such as how
to overcome the true barriers to breastfeeding."

# # #

*IFC is an international association of manufacturers and marketers of
formulated nutrition products (e.g., infant formulas and adult nutritionals)
whose members are predominantly based in North America. IFC members include
all major U.S. manufacturers: Mead Johnson Nutritionals; Nestle USA, Inc.,
Nutrition Division; Ross Products Division, Abbott Laboratories; Solus
Products; and Wyeth Nutrition.<<<


Pat W

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