Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine . All content is Derek’s own, and he does not in any way speak for his employer.

Chemjobber put me on to this lawsuit filing, which is brought by the Organic Consumer’s Association versus The Honest Company. To decode all these, the OCA is an advocacy group (one of the most aggressive) for organic farming, and gets its funding both from its members and from the organic farming industry. You can pretty much fill in what they think about Monsanto, genetically modified organisms, and so on, and they’ve also been very critical of larger corporations’ activities in the organic foods business. To give you an idea of where they’re coming from, here’s an article from a couple of years back from them, arguing that Big Pharma and their henchmen are ignoring the all-natural ways to prevent and treat Ebola.

They’re going after the Honest people for their infant formula, which they say is falsely marketed as being “organic”. Their specific complaints are interesting on two levels. From a legal standpoint, just based on what I can see, they may well have grounds for complaint (see their paragraphs 5 through 11). There are apparently specific lists of what can go into a marketed product under the California Organic Products Act, and the lawsuit claims that several ingredients in the Honest product are not on those lists. I haven’t read the text of the law, but if the OCA has represented things accurately, that would seem to be their strongest argument – again, just on a legal basis, without reference to what one thinks of the whole “organic” business, the COPA, etc.

But the rest of the document. . .oh, boy. The OCA is not content to come in with a suit that says that these things have to be on this list, and they’re not. Instead, they go on, and on, and on about each substance and its horrible nonorganic nefariousness. Here, for example, is their take on sodium selenite:

Sodium Selenite is a hazardous substance. See, e.g., 40 C.F.R. §§ 116.4, 302.4. The FDA allows it to be added to animal feed, 21 C.F.R. § 573.920, but it has never been determined it to be safe to be added to foods for human consumption. Even at very low doses, animal studies show it has negative effects on the respiratory, gastrointestinal, cardiovascular, and metabolic systems, negatively impacts the liver, and has negative broad systemic effects. It is not permitted to be added to products labeled as “organic.”

Actually, guys, pretty much all selenium compounds (at least those that have a chance of being bioavailable) are hazardous substances. And yet selenium is an essential trace element, with nasty consequences if you don’t get it in your diet. Sodium selenite has been used as a selenium-fortifying substance for decades. Let’s try taurine next:

Taurine, a.k.a. 1, 2-aminoethanesulfonic acid, is not permitted in products labeled as “organic.” 7 C.F.R. §§ 205.105(c), 205.605; Cal. Health & Safety Code § 110820(b). In fact, the National Organic Standards Board (“NOSB”) specifically rejected applications to permit taurine to be added to organic products. See Exhibit 4. Even at very low doses, animal studies show the ingredient negatively impacts the brain and nervous system, metabolism, and cardiovascular system. Commercially available taurine is synthetically produced by reacting ethylene oxide with aqueous sodium bisulfate, reacting aziridine with sulfurous acid, or reacting monoethanolamine, sulfuric acid, and sodium sulfite. The FDA has not affirmed taurine to be safe in foods.

Note the emphasis on the synthetic, unnatural routes of preparation, complete with the full chemical names: it’s an evil chemical made in a vat. But also note that taurine is, in fact, produced in the human body (there’s plenty of it in bile) and is also found in all sorts of other animal tissues. So it’s hard to figure out how such low doses of it impact the brain and all those other systems, when we’re basically soaking in it, and when it’s been found to be essential for those systems to develop and function. And as for the FDA having “not affirmed” taurine to be safe in foods, well, every serving of meat and fish ever eaten has taurine in it, and the agency itself has said that it finds no reason to believe that taurine in unsafe in (say) energy drinks and the like, where it’s a common ingredient.

Let’s go on to another compound on their list, ascorbyl palmitate:

Ascorbyl palmitate is a chemical preservative. 21 C.F.R. § 182.3149. It is not permitted in organic products. 7 C.F.R. §§ 205.105(c), 205.605; Cal. Health & Safety Code § 110820. Nonetheless, Honest adds ascorbyl palmitate to its so-called “Organic” Infant Formula, despite the fact that the NOSB specifically rejected applications to permit ascorbyl palmitate to be added to such products. See Exhibit 5. Ascorbyl palmitate is prepared by condensing palmitoyl chloride and ascorbic acid in the presence of a dehydrochlorinating agent such as pyridine. It can also be produced by esterifying ascorbic acid with sulfuric acid, and then with palmitic acid. Other patented processes use dimethylformamide, dimethyl sulfoxide, or hydrogen fluoride instead of sulfuric acid.

Scary stuff, clearly – even though it breaks down in the body to palmitic acid (a naturally occurring fatty acid) and vitamin C. But the OCA is probably right that it’s not on the list, so their legal objection would stand. The next one is a particular favorite of mine in the document:

Calcium pantothenate is synthetically prepared from isobutyraldehyde, a synthetic flavoring substance and toxic chemical, 21 C.F.R. § 184.1212, 40 C.F.R. § 372.65, and formaldehyde, a hazardous substance, 40 C.F.R. § 116.4, via 1,1-dimethyl-2-hydroxypropionaldehyde and pantolactone, 21 C.F.R. § 184.1212. It is not allowed in organic products. See 7 C.F.R. §§ 205.105(c), 205.605; Cal. Health & Safety Code § 110820.

They go on to show a structure diagram of the compound and to say that “Calcium pantothenate is not the same substance as vitamin B5“. Why no, it’s the calcium salt of vitamin B5. But if you take a dose of all-natural vitamin B5, isolated by bearded artisans with only hand-made tools, and washed it down with fresh warm non-GMO milk straight from the cow, you are getting some calcium panthothenate. And I particularly like the reference to the preparation from isobutyraldehyde. The OCA would be interested to know that the all-natural route to pantothenate (which the human body cannot make for itself) is found in toxic, disease-causing bacteria, among others, and involves intermediates with names like ketovalerate and beta-alanine, which the FDA have not affirmed to be safe in foods. Here’s another favorite from the list:

Cholecalciferol is also a synthetic compound. 7 C.F.R. § 205.601. Cholecalciferol can be produced from fish liver oils, but Honest’s labels do not indicate that any ingredient was derived from seafood. The other method of production requires ultraviolet irradiation of ergosterol isolated from yeast and related fungi and purified by crystallization, or ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol. See 21 C.F.R. § 184.1950(a). Irradiated substances like cholecalciferol are not allowed in organic products. See 7 C.F.R. § 205.105(f); Cal. Health & Safety Code § 110820.

Well, it’s true that the cholecalciferol (a form of vitamin D) that’s added to food is a synthetic substance. And as stated, it’s made on scale by a reaction involving ultraviolet light, which is where all that “irradiated substance” talk comes from. But guess what, guys! It’s made in your body by the action of ultraviolet light penetrating your skin – yep, the all-natural form in your own hemp-clad, Dr. Bronner’s-soap-washed body is an “irradiated substance”. There’s no other way to get it. Freak out now.

The other substances the OCA objects to are in a similar vein – biotin, beta-carotene, and other well-known industrial toxins. Their problem with many of them is that they’re “synthetic”, which is pure vitalism – the idea that substances have some sort of essence, some vital spark, when they’re taken from a living organism as opposed to being drained out of some crusty, fuming vat. But biomolecules are biomolecules, and the pure substances are the pure substances, no matter how they’re made. So you get statements in the lawsuit such as “Phytonadione is not the same substance as phylloquinone“, when these are in fact two names for the exact same chemical substance, indistinguishable even by organic food activists.

But let me finish up with an observation. That OCA link above, about preventing and treating Ebola with all-natural stuff instead of, like, toxic drugs and chemicals? It recommends that people take more selenium. And get more vitamin D. And lots of Vitamin C. Let’s pretend that we live in a world where vitamin supplements can treat Ebola (we don’t, by the way): what would be some of the cheapest ways to treat all those desperately ill patients in the tropics with these vitamins? Why, sodium selenite, cholecalciferol, and ascorbyl palmitate. But I’m sure that those wouldn’t count. They’re not organic, right?