Phthalates are also:
- Proven to decrease sperm counts in extensive laboratory studies on rodents; reduce fertility in both males and females; and cause testicular atrophy, birth defects (including skeletal malformation and cleft palate), "small or absent reproductive organs," developmental delays, and miscarriages;
- Proven endocrine disruptors, as admitted by the FDA, that have been shown, in humans, to have reproductive and developmental toxicity resulting in birth defects and low sperm counts;
- Detectably present in 95% of Americans' urine;
- Banned, by Congress, from children's toys;
- Identified by the European Commission as reproductive toxicants and banned from cosmetics produced in the EU;
- According to the American Chemistry Council, a lobby group for phthalate manufacturers, "totally safe;" and
- Used as a plasticizer in coated, extended-release prescription pills, as a recent article in Dr. Robert J. Rowen's Second Opinion newsletter reminded us.
Essentially, the 2012 guidance lists the plethora of health issues associated with phthalates, and then politely asks drug companies not to use DBP or DEHP in their drugs. This is despite the fact that the FDA has full power to ban phthalates and - in the text of the guidance - admits that "exposure to DBP and DEHP from pharmaceuticals presents a potential risk of developmental and reproductive toxicity" and "safer alternatives are available."
Two years later, the response from Big Pharma is about what you'd expect. On the upside, Prilosec, despite its numerous other faults, no longer contains phthalates, nor does generic theophylline. On the downside, Asacol, a drug for ulcerative colitis produced by Actavis Pharma, still contains DBP, as does mesalamine, the generic form of Asacol; didanosine (brand name Videx) contains DBP; and omeprazole, a generic heartburn prescription, contains DEHP. Additionally, phthalates are also present in at least fifteen other drugs.
It's been well established that patients who take drugs containing phthalates absorb that chemical into their body: in 2008, a man became infertile after taking Asacol daily for just three months (he had 100 times more DBP in his system that the EPA considers safe). Studies have also found that the average urine concentration of DBP in mesalamine users is fifty times higher than non-users, and elevated phthalate levels are also detectable in omeprazole, didanosine, and theophylline users.
Why would the FDA issue a voluntary guidance, when they have the power to ban harmful substances outright?
The answer, as always, can be reduced to three little words: "Follow the money." Drug companies today pay a large proportion of the FDA's budget, and FDA career personnel may hope to work for drug companies later in their career.
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