FDA and Milk Regulation

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“In one sense this is yet another ridiculous example of the United States Government getting involved in a situation in which it should have no say. We all should have concerns when the FDA releases comments such as the following:”

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The FDA has apparently decided that a certain sector of milk production in the United States does not have enough regulation in sales, barter or sharing. This agency would direct one to this statement:

“Risks… include exposure to infectious diseases, to chemical contaminants such as some illegal drugs, and to a limited number of prescription drugs that might be in the… milk, if … not been adequately screened.”

Pretty serious as it should be. According to the FDA this milk can be contaminated with a variety of illegal substances including STDs, environmental contaminants, herbal supplements, pharmaceuticals (with the exception of progestin-only BCP- that seems “acceptable”) – yet consumers are willing to pay up to $5.00 per ounce. Purchasers are even willing to take the “risk” of securing this substance from “unapproved” sources and even contemplate “flash pasteurization” for safety.

Therefore more “Regulation and Study” is needed in this field. Of course until then one should only purchase from sources deemed safe by the FDA such as HMBANA.

If one hasn’t figured this out by now – the FDA is discussing the Regulation of Human Breast Milk. While this dangerous substance has indeed been used for a recent assault in Kentucky, the curious mind would like to dissect why this issue and why now? In light of FDAs stellar record of Regulating the Blood Supply, Semen Usage and IVF clinics – why should anyone trust or accept any future “guidelines” from this agency?

Before one says “Why those were just isolated incidents!” understand that the increase of regulation has not created responsibility among the Industry, but disseminated responsibility until the thin line of accountability and efficiency is currently like a sheet of rice paper. See through and fragile.

In the interest of “Regulated Industry” I believe one can find the answer of the puzzling question

A title of this little piece as “Bungling Boobies Bust B-Cup Bandits” or “Milky Moms Market Moist Menace” maybe even “Dangerous D’ecolletage Divides Donors” might have garnered a few more hits, in reality the seriousness of this situation begins to be addressed once we look at the potential industry of breast milk. In the interest of said “Regulated Industry” I believe one can find the answer of the puzzling question.

The breast milk Industry is charging users, which may or may not be covered by insurance,$3 – $5 per ounce according to Time Magazine. If one takes the average of $4 per ounce that equates $512 per gallon. While no numbers are available from HMBANA, according to their site “745,329 ounces of milk 2005” was donated and “shared” throughout the United States. Of course a “Prescription” is needed for outpatient usage which may not be covered by Insurance. Believe it or not, that is a $3 Million Dollar industry. One wonders what current numbers apply here. (Update: According to NBC, HMBANA processed 1.5 million ounces last year or an estimated $6 million dollars of product – an increase of 100% in the last 4 years).

An average 10 pound infant would consume 22.5 ounces of formula or breast milk daily. Industry cost? $90 per day. On the other side we have a fully “un-regulated” industry in which new mothers can”milk-share” and determine their own price. Eats On Feets is an organization which supports direct Consumer to Producer interface. This perhaps is where the FDAs issue originates. Regulation and “infant food safety”.

How long until un-regulated Interstate Commerce is addressed here?

How long until the stories of back alley deals of illegal milk sales throughout the country are reported?

Raids – well how exactly does the FDA propose seizing the evidence?

What about Taxing the Income made?

There are still “Household Staffing” firms who provide Wet Nurse services along with Bodyguards, Butlers, or Household Managers – how exactly is that Regulated?

What about the damage caused to the Infant Formula Industry? According to Wiki:

In the United States, infant formula is heavily subsidized by the government: at least one third of the US market is supported by the government,^[70] with over half of infant formula in the US provided through WIC^[67] – WIC is the US food aid program, not a medical program, which is Medicaid. Breastfeeding rates are substantially lower for WIC recipients;^[71] this is partly attributed to formula being free of charge to WIC mothers, and partly to WIC recipients being poor and uneducated, hence less likely to breastfeed.^[67] Further, some promotional materials use the WIC trademark, in violation of federal policy.^[71] Infant formula costs are a significant fraction of WIC costs: 21% post-rebate, and 46% pre-rebate.^[67] Formula manufacturers are granted a WIC monopoly in individual states – only one brand of formula will be eligible for WIC.^[67]

WIC also pays for milk banks.^[72]^[73]

In one sense this is yet another ridiculous example of the United States Government getting involved in a situation in which it should have no say. We all should have concerns when the FDA releases comments such as the following:

FDA Deputy Commissioner Dr. Josh Sharfstein told the advisers that the agency backs breast-feeding, but is deciding whether to get involved in regulating donated milk.

“FDA doesn’t have plans at this time to enhance its role in donated breast milk,” said Sharfstein, a pediatrician. But involvement “in a reasonable way” is possible, he added.

Of course the FDA will decide the “reasonable way” and the time line – they always do.

Of a larger concern is the continued process of hindering unregulated free market trade in yet another sector of the American Public. Apparently Milk may “do a body good”, but only if fully vetted, taxed and monitored.