Editing Infant formula (section)

==Policy, industry and marketing==
The policy, regulatory and industry environments surrounding the infant formula market vary tremendously between countries.

===International===
{{Main|International Code of Marketing of Breast-milk Substitutes}}
{{See also|Nestlé boycott}}

The [[International Code of Marketing of Breast-milk Substitutes]] is an international [[health policy]] framework adopted by the [[World Health Assembly]] of the [[WHO]] in 1981 regarding infant formula marketing, including strict restrictions on advertising.<ref name="ICMBS"/> Its implementation depends on the laws of different countries and the behavior of infant formula manufacturers – the code has no power itself. Legislation and corporate behavior vary significantly between countries: at least 84 countries have enacted national legislation implementing all or many of the provisions of the Code and 14 countries have draft laws awaiting adoption;<ref>UNICEF. [http://www.unicef.org/nutrition/index_24805.html International Code of Marketing of Breast-milk Substitutes.] {{Webarchive|url=https://web.archive.org/web/20171212070106/https://www.unicef.org/nutrition/index_24805.html |date=December 12, 2017 }} Retrieved August 9, 2011.</ref> whereas elsewhere neither the Code nor its principles are followed by governments or formula manufacturers.

Practices that are banned in the Code include most advertising, claiming health benefits for formula, and giving [[Product sample|free samples]] to women able to breastfeed – this latter practice is particularly criticized because it can interfere with lactation, creating dependence on formula, without proper education on ensuring continued breast stimulation while formula is being used. In many countries free samples of infant formula have been provided to hospitals for decades; infant formula is often the only product routinely provided free of charge to hospitals.<ref>Counseling the nursing mother, By Judith Lauwers, Anna Swisher, [https://books.google.com/books?id=crW6348Iw_wC&pg=PA597 p. 597]</ref> The [[Baby Friendly Hospital Initiative]] (BFHI) aims to reduce and eliminate this controversial practice; however, there is increasing criticism of the BFHI's rigidity in limiting use of infant formula, which can be an appropriate treatment for common conditions such as suboptimal intake jaundice, and may cause mothers to feel pressured or guilted into breastfeeding.<ref>{{Cite journal |last=Wilde |first=Vera K |date=2021-10-04 |title=Breastfeeding Insufficiencies: Common and Preventable Harm to Neonates |journal=Cureus |volume=13 |issue=10 |pages=e18478 |language=en |doi=10.7759/cureus.18478 |doi-access=free |issn=2168-8184 |pmc=8491802 |pmid=34659917}}</ref><ref>{{Cite journal |last1=Howard |first1=Tera F. |last2=Hinten |first2=Brittany |last3=Ott |first3=Corilyn Mae |last4=Ye |first4=Yuanfan |last5=Tita |first5=Alan T.N. |date=2022-01-01 |title=What Women Really Think About Breastfeeding and Breast Pumping: A Qualitative Analysis of Women Who Deliver at a Baby-Friendly Hospital |url=https://www.liebertpub.com/doi/10.1089/bfm.2021.0135 |journal=Breastfeeding Medicine |volume=17 |issue=1 |pages=65–71 |doi=10.1089/bfm.2021.0135 |pmid=34919409 |s2cid=245279889 |issn=1556-8253|url-access=subscription }}</ref><ref>{{Cite journal |last1=Flaherman |first1=Valerie |last2=Von Kohorn |first2=Isabelle |date=2016-10-25 |title=Interventions Intended to Support Breastfeeding: Updated Assessment of Benefits and Harms |url=http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.15083 |journal=JAMA |language=en |volume=316 |issue=16 |pages=1685–1687 |doi=10.1001/jama.2016.15083 |pmid=27784077 |issn=0098-7484|url-access=subscription }}</ref>

===By country===

====Philippines====
Infant formula is one of the top three consumer commodities in the Philippines, and among the most imported products.<ref name="milkwars">[https://globalvoicesonline.org/2007/07/11/milk-wars-in-the-philippines-breastmilk-versus-infant-formula/ Milk wars in the Philippines: Breastmilk versus Infant Formula], ''Global Voices'', posted July 11, 2007.</ref> Annual sales amount to some US$469 million annually. US$88 million is spent on advertising the product.<ref name=ATrirr>Cher S Jimenez, [https://web.archive.org/web/20071011113818/http://atimes.com/atimes/Southeast_Asia/IG25Ae01.html Spilled corporate milk in the Philippines], ''Asia Times Online'', July 25, 2007, Retrieved 22 December 2008.</ref>

Infant formula marketing has been regulated since the 1987 Executive Order 51 or "Milk Code",<ref name="milkcode" /> which regulated, but did not ban, practices such as advertising and providing free samples. Shortly after it was enacted, [[Wyeth]] introduced "follow-on formula", which was not in the purview of the Milk Code which predated its market entry.

In 2006, the [[Department of Health (Philippines)|Department of Health]] banned the advertising of infant formula and the practice of providing free samples, regardless of intended age group (in the ''Revised Implementing Rules and Regulations'' of Executive Order 51, or RIRR).<ref name="UNICEF-P">UNICEF Philippines. [http://www.unicef.org/philippines/news/061101.html Breastfeeding advocates form consolidated action against formula companies.] {{Webarchive|url=https://web.archive.org/web/20100710002946/http://www.unicef.org/philippines/news/061101.html |date=July 10, 2010 }} Makati City, November 13, 2006. Retrieved August 9, 2011.</ref> The new regulation was challenged by the infant formula industry in the Supreme Court. Initially the challenge was dismissed, but this decision was reversed following industry pressure and a controversial letter by American business leader Thomas Donahue,<ref>{{cite web|url=http://pcij.org/blog/wp-docs/US_Chamber_of_Commerce_Letter.pdf|title=Letter by Thomas Donahue, August 11, 2006|website=pcij.org|access-date=April 3, 2018|archive-date=November 8, 2016|archive-url=https://web.archive.org/web/20161108053124/http://pcij.org/blog/wp-docs/US_Chamber_of_Commerce_Letter.pdf|url-status=dead}}</ref> then President and CEO of the [[United States Chamber of Commerce|US Chamber of Commerce]], resulting in the regulation being suspended and advertising continuing.<ref name="milkwars"/><ref name="milkcode">{{cite web|url=http://www.pcij.org/blog/?p=1789|title=The Philippine Milk Code: A timeline|date=June 20, 2007|website=pcij.org|access-date=April 3, 2018|archive-url=https://web.archive.org/web/20100825211915/http://www.pcij.org/blog/?p=1789|archive-date=August 25, 2010|url-status=dead}}</ref><ref name="UNICEF-P"/><ref>{{cite web|url=http://www.pcij.org/blog/?p=1788|title=Breast or bottle: The final showdown|date=June 20, 2007|website=pcij.org|access-date=April 3, 2018|archive-date=July 29, 2010|archive-url=https://web.archive.org/web/20100729035119/http://www.pcij.org/blog/?p=1788|url-status=dead}}</ref>
 
''[[The Guardian]]'' newspaper reports widespread illegal advertising and marketing of formula milk contrary to [[World Health Organization]] guidelines. Doctors and midwives are encouraged to promote feeding babies formula milk, advertising also targets mothers directly. Babies get sick and sometimes die because poor mothers cannot sterilize bottles.<ref>[https://www.theguardian.com/lifeandstyle/2018/feb/27/formula-milk-companies-target-poor-mothers-breastfeeding How formula milk firms target mothers who can least afford it] ''[[The Guardian]]''</ref>

==== South Africa ====
In South Africa, there is a move towards plain packaging of infant formula<ref>[https://blogs.sun.ac.za/iplaw/2013/12/03/formula-for-plain-bland-packaging/ Formula for Plain (Bland) Packaging] ''The Anton Mostert Chair of Intellectual Property'', December 3, 2013. Retrieved 24 July, 2014</ref> under R 991 of the Foodstuffs, Cosmetics and Disinfectants Act; as of 6 December 2013, Regulation 7 (Sale and Promotion) is force, whereas Regulations 2-6 (primarily with respect to labelling) are scheduled to come into force on 6 December 2014.
One of the key requirements as per Regulation 3.1.A.iii is a conspicuous message stating “[t]his product shall only be used on the advice of a health professional”.

==== Thailand ====
In 2017, Thailand banned advertising for infant formula. Initially a ban on advertising for toddler formula was also proposed, but was dropped after the intervention of United States trade officials.<ref>{{Cite web |last=Tri-yasakda |first=Heather Vogell,June Watsamon |date=2024-03-21 |title=The U.S. Government Defended the Overseas Business Interests of Baby Formula Makers. Kids Paid the Price. |url=https://www.propublica.org/article/how-america-waged-global-campaign-against-baby-formula-regulation-thailand |access-date=2024-04-07 |website=ProPublica |language=en}}</ref>

==== United Kingdom ====
In the United Kingdom, infant formula advertising has been allowed since 1995;<ref>{{cite web|url=https://www.opsi.gov.uk/si/si1995/Uksi_19950077_en_1.htm|title=The Infant Formula and Follow–on Formula Regulations 1995|website=www.opsi.gov.uk|access-date=April 3, 2018}}</ref> advertising for "follow-on formula" is legal, which has been cited as a loophole allowing advertising of similarly packaged formula.<ref name="loophole">{{cite web|url=http://www.babyfriendly.org.uk/items/item_detail.asp?item=47|title=The Unicef UK Baby Friendly Initiative|website=Baby Friendly Initiative|access-date=April 3, 2018}}</ref>

==== United States ====

In the United States, infant formula is both heavily marketed—the country has not adopted [[International Code of Marketing of Breast-milk Substitutes|the Code]], nor is it being systematically implemented by manufacturers for domestic marketing<ref>[http://www.breastfeedingbasics.org/cgi-bin/deliver.cgi/content/International/his_code.html Breastfeeding Around the World: The International Code of Marketing of Breast Milk Substitutes.] {{webarchive|url=https://web.archive.org/web/20110503210250/http://breastfeedingbasics.org/cgi-bin/deliver.cgi/content/International/his_code.html |date=May 3, 2011 }} Retrieved August 9, 2011.</ref>—and even heavily [[subsidy|subsidized]] by the government: at least one third of the American market is supported by the government,<ref name="kaminis"/> with over half of infant formula sold in the country provided through the [[Special Supplemental Nutrition Program for Women, Infants, and Children]] (known as [[WIC program|WIC]]).<ref name="whopays">[http://www.ers.usda.gov/AmberWaves/September04/Features/infantformula.htm Sharing the Economic Burden: Who Pays for WIC’s Infant Formula?] {{webarchive|url=https://web.archive.org/web/20090511224550/http://ers.usda.gov/AmberWaves/September04/Features/infantformula.htm |date=May 11, 2009 }}, ''AmberWaves'', September 2004.</ref>

According to surveys, over 70% of large U.S. hospitals dispense infant formula to all infants, a practice opposed by the [[American Academy of Pediatrics]] and in violation of the Code.<ref name="AAPad">[http://www.aap.org/research/periodicsurvey/ps13.htm Periodic Survey of Fellows: Survey shows most AAP members support formula advertising policy] {{webarchive|url=https://web.archive.org/web/20110321185321/http://www.aap.org/research/periodicsurvey/ps13.htm |date=March 21, 2011 }}, American Academy of Pediatrics (AAP).</ref> The [[Gerber Products Company]] began marketing its brand of infant formula directly to the public in October 1989, while the [[Carnation Company]] began marketing ''Good Start'' infant formula directly to the public in January 1991.<ref name="AAPad" />

Infant formula costs are a significant fraction of the WIC program costs: 21% post-rebate and 46% pre-rebate.<ref name="whopays"/> Formula manufacturers are granted a WIC monopoly in individual states.<ref name="whopays"/> Meanwhile, breastfeeding rates are substantially lower for WIC recipients;<ref name="gao">[http://www.gao.gov/htext/d06282.html Breastfeeding: Some Strategies Used to Market Infant Formula May Discourage Breastfeeding; State Contracts Should Better Protect against Misuse of WIC Name] {{Webarchive|url=https://web.archive.org/web/20160303183249/http://www.gao.gov/htext/d06282.html |date=March 3, 2016 }}, U.S. Government Accountability Office (GAO)</ref> this is partly attributed to formula being free of charge to mothers in the WIC program, who are of lower socio-economic status.<ref name="whopays"/> Violations of federal policy have also been found in terms of infant formula company advertising using the WIC trademark, to reach both WIC and non-WIC participants.<ref name="gao"/> In recent years WIC has been expanding its [[breastfeeding promotion]] strategies, including providing subsidies for clients who use [[milk bank]]s.<ref>[http://www.breastfeeding.com/all_about/all_about_milk_banks.html Banking on Breastmilk] {{webarchive|url=https://web.archive.org/web/20090531022711/http://www.breastfeeding.com/all_about/all_about_milk_banks.html |date=May 31, 2009 }}</ref>

=== 2022 United States Baby Formula Shortages ===

[[2021–2022 global supply chain crisis|Supply chain disruptions]] related to the government response to the [[COVID-19 pandemic in the United States]] have been reported<ref name="US 2022 infant formula shortage – Reason" /> as responsible for causing widespread [[2022 United States infant formula shortage|shortages of infant formula]] in the United States, as of May 2022. This contrasts with far less severe shortages of infant formula around the globe. [[Reason (magazine)|Reason magazine]] reported that this was largely the result of [[Food and Drug Administration]] (FDA) processes delaying approval of otherwise safe infant formula from Europe or other sources abroad, which might otherwise have eased demand for infant formula tensions in the United States.<ref name="US 2022 infant formula shortage – Reason">{{cite web |last1=Soave |first1=Robby |title=The U.S. Baby Formula Shortage Is the FDA's Fault |url=https://reason.com/2022/05/10/baby-formula-shortage-fda-approval-biden/ |website=reason.com |date=May 10, 2022 |publisher=Reason |access-date=13 May 2022}}</ref>

As a result of the shortages, on May 16, 2022, the FDA announced that it would temporarily ease enforcement of some labeling rules to allow the importation of foreign formulas. FDA Commissioner [[Robert Califf]] stated, "Today's action paves the way for companies who don't normally distribute their infant formula products in the U.S. to do so efficiently and safely. We anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks."<ref>{{cite web|url=https://www.fda.gov/news-events/press-announcements/fda-encourages-importation-safe-infant-formula-and-other-flexibilities-further-increase-availability|archive-url=https://web.archive.org/web/20220516223533/https://www.fda.gov/news-events/press-announcements/fda-encourages-importation-safe-infant-formula-and-other-flexibilities-further-increase-availability|url-status=dead|archive-date=May 16, 2022|title=FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability |website=[[Food and Drug Administration]] |date=May 16, 2022}}</ref> Former FDA associate commissioner, Peter Pitts, asserts that the FDA's regulatory scheme is at least partially to blame for the shortage. Pitts states, "The difference between European baby formula and American baby formula, more or less, is that the labeling is different. The knot in getting that product into the U.S. isn't safety, it's a regulatory issue. I don't want to say it's a nitty issue, but it's certainly something the FDA could have jumped on a lot quicker."<ref>{{cite web|url=https://reason.com/2022/05/17/fda-baby-formula-peter-pitts-safety-european-shortage/|title=Former FDA Official: The Prohibition on European Baby Formula Isn't About Safety | date=May 17, 2022}}</ref>

Amid and prior to the formula shortages, Woman and Infant Children (WIC) centers in Georgia and North Carolina were disposing of infant formula.<ref>{{cite news|url=https://www.ajc.com/news/georgia-news/georgia-destroys-thousands-of-dollars-worth-of-baby-formula-every-year-heres-why/NJWSS6MYCNE57GVXINABGAK4MU/|title=Georgia destroys thousands of cans of baby formula every year. Here's why. |newspaper=The Atlanta Journal-Constitution |date=May 22, 2022|last1=Grinspan |first1=Lautaro }}</ref><ref>{{cite web|url=https://www.wral.com/investigation-finds-nc-destroying-infant-formula-supplies-despite-shortages/20312111/|title=WRAL INVESTIGATES Investigation finds NC destroying infant formula supplies despite shortages |date=June 2, 2022}}</ref>   This was done under the USDA's recommendation that unused, returned WIC infant formula were to be disposed of upon return.<ref>{{cite web|url=https://fnsprod.azureedge.us/sites/default/files/resource-files/WPM-2020-1-DonationofUnsedReturnedInfantFormula.pdf |title=WIC Policy Memo 2020-1: Donation of Unsed Returned Infant Formula |date=December 12, 2019}}{{Dead link|date=February 2023}}</ref> Despite an attempt by the USDA to walk back this recommendation by stating that it is a recommendation rather than a requirement, the USDA confirms that it will not reverse this recommendation, even amid the formula shortage.<ref>{{cite web|url=https://reason.com/2022/06/08/following-usda-guidance-state-clinics-destroyed-thousands-of-cans-of-usable-baby-formula/ |title=Following USDA Guidance, State Clinics Destroyed Thousands of Cans of Usable Baby Formula |date=June 8, 2022}}</ref> As a result, from October 2021 through May 2022, 16,459 cans of baby formula were destroyed by WIC clinics in Georgia and an unknown amount of baby formula cans were destroyed in North Carolina and other US States.

On July 6, 2022, the FDA announced that it would change its rules to allow foreign formula manufacturers to permanently import their goods into the U.S., potentially reducing the severity of the shortage.<ref>{{cite web|url=https://www.fda.gov/news-events/press-announcements/fda-developing-new-framework-continued-expanded-access-infant-formula-options-us-parents-and|archive-url=https://web.archive.org/web/20220706185158/https://www.fda.gov/news-events/press-announcements/fda-developing-new-framework-continued-expanded-access-infant-formula-options-us-parents-and|url-status=dead|archive-date=July 6, 2022|title=FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers|website=[[Food and Drug Administration]] |date=July 6, 2022}}</ref> Critics of the FDA note that this does not remove the regulations entirely and that this shortage has been self-imposed by the FDA from the start.<ref>{{cite web|url=https://reason.com/2022/07/07/fda-finally-admits-it-caused-the-baby-formula-shortage/|title=FDA Finally Admits It Caused the Baby Formula Shortage|date=July 7, 2022}}</ref> Additionally, critics note that if a formula maker passes EU regulations, this should be good enough for the FDA to allow importation of that formula.

Critics of the FDA's regulatory policy note that the regulatory scheme surrounding European formulas is not borne from a science-based desire to protect children, but rather an influence that the US dairy industry has on the agency.<ref>{{cite web|url=https://www.usdec.org/Documents/TPA-105-003_Public%20Comments_NMPF%20USDEC%20ITC%20USMCA%20Submission.12.20.18.pdf|title=Submission by the U.S. Dairy Export Council and the National Milk Producers FederationRegarding United States-Mexico-Canada Agreement: Likely Impact on the U.S. Economy andon Specific Industry Sectors (Investigation No. TPA-105-003)|date=December 20, 2018|access-date=October 13, 2022|archive-date=April 19, 2022|archive-url=https://web.archive.org/web/20220419140913/https://www.usdec.org/Documents/TPA-105-003_Public%20Comments_NMPF%20USDEC%20ITC%20USMCA%20Submission.12.20.18.pdf|url-status=dead}}</ref><ref name="reason.com">{{cite web|url=https://reason.com/2022/07/25/my-baby-needed-special-formula-from-europe-u-s-trade-policy-made-it-almost-unobtainable/|title=My Baby Needed Special Formula From Europe. U.S. Trade Policy Made It Almost Unobtainable.|date=July 25, 2022}}</ref>  Critics also note that if there were an issue with European formulas, the issue would be widespread among the European babies that regularly consume the formula.<ref>{{cite web|url=https://www.nytimes.com/wirecutter/blog/us-parents-european-baby-formula/|title=Why US Parents Are Choosing European Baby Formula|website=[[The New York Times]] |date=March 12, 2021}}</ref><ref name="reason.com"/>

The FORMULA Act is set to expire at the end of 2022, which will subsequently reinstate tariffs on foreign made formula.<ref>{{cite web|url=https://www.congress.gov/bill/117th-congress/house-bill/8351|title=H.R.8351 - Formula Act|date=July 13, 2022}}</ref>  Experts worry that this will result in a repeat formula shortage for 2023.<ref>{{cite web|url=https://reason.com/2022/12/13/the-government-hasnt-learned-a-thing-from-the-baby-formula-shortage/|title=The Government Hasn't Learned a Thing From the Baby Formula Shortage|date=December 13, 2022}}</ref> The CEO of the National Milk Producers Federation, a lobbying organization for dairy producers, wrote in a letter to Congress and the Biden administration to allow for the reinstatement of tariffs on foreign baby formula to commence.<ref>{{cite web|url=https://www.nmpf.org/wp-content/uploads/2022/11/NMPF-Letter-to-Congress-on-Restoration-of-US-Formula-Tariffs_Nov-17-2022.pdf|title=National Milk Producers Federation Letter to Congress|date=November 17, 2022}}</ref>