Magickal Realism

The perfumers and bath and body creators who use synthetics (i.e. fragrance oils) presumably have good reasons for using them. Usually, the reason is purefly financial: synthetics are produced cheap and let’s face it, most big-name perfumers are trapped in the corporate spiral so cheap the materials must be. Sometimes, it’s for a legitimately ethical reason: using the synthetic options may prevent the actual plant from going extinct through overuse.
Sometimes the scent can’t be found in nature to begin with.

I get it, I do. I just won’t do it - I like my naturals, well, natural. What’s alternately amusing/irritating me is this “praise synthetics/slam naturalism” bent I’m seeing more and more of out of the big-names in the perfume industry. The reason it’s tweaking me is that I can smell their fear, and it’s pure, superstitious, baloney fear, the kind that led to people getting stuffed in Iron Maidens during the Inquisition. These superstitious are frothing forth from men who claim “scientist” in their job title. Apparently “unscientific” is the new “heretic” among perfumers. Should I fear someone from Quest Chemicals is going to show up at my door and haul me off for perverting people with natural materials? Will my oils be cataloged and hidden in some basement with secret passageways that lead to the Vatican? Geez, I thought I had enough to fear living under a regime run by George Bush. It’s a sad day - I openly practice witchcraft, and I’m less fearful and superstitious than these science types.

I’ve been staying away from the synthetics debate because I haven’t researched synthetics that thoroughly, and I just don’t know the materials as initimately as I do natural materials. But this completely unsubtle movement against naturals has my hackles up: there’s something going on behind the scenes, and the syntheticists are scared, so scared that they’re bullying and slamming every naturalist they can. Perfume and Flavorist has started a series called In Praise of Synthetics. In an interview on National Public Radio on January 21st, Chandler Burr felt it necessary to close his interview with an unasked-about and ompletely unnecessary slam against the naturals movement. It’s not the first time he’s made that slam, either, even though from what I gather, no one was asking then, either. IFRA has been doing its darnedest to make synthetics our only chemical option in perfume creation, going so far as to issue unresearched data indicating natural materials are far more allergenic than they actually are (and conveniently ignoring the nature of allergy and the way that allergy works.)What makes much of this naturalists-stalking so ridiculous and Inquisition-like is that even among artisan perfumers, those of us actively in business as natural perfumers are something of a rarity - so much so that we don’t really have accurate numbers for how many of us there are. To get down to the numbers you would have to sort out people who make perfume only as a hobby (I would guess that’s most of us) from smartasses with an eyedropper and a few oils (next level) from those of us actively in business. Among those of us who are actively in business, you would have to separate the essential oil suppliers from the specialists.

I would place myself under that last group of specialists and I suspect my circumstances are still nontypical. Most home bath and body makers in the US are in soap, because soap is where the money is at here. Those of us still specializing in perfume are micro-businesses; our market share is people who are either perfume collectors who purchase equally from artisan naturalists and big name companies, or who have a deep-seated animosity towards syntheticists and their ilk that no amount of praising synthetics is going to unseat.

So far, I’ve left synthetics alone, just because I prefer not to use them. But the way the big chemical makers are carrying on is smelling like a superstition-driven witch hunt. So excuse me, I’m going to go hug my all-natural perfume organ now.

I occurs to me as I look back on the last entry that the last line about making claims about natural materials (saying something is natural when it’s not) is not actually what is practiced. Because of the loopholes on this particular regulation, an entire board of certification - i.e. USDA Certified Organic - has become necessary. It’s a topic that will be covered and probably revisited often. In the mean time, simply accept with as much calm as you can muster that what the law intends is not always what the law says and consequently, a regulation may not be enforced in the manner by which most people would interpret it. If people just took the law at its word AND intent, the legal industry in the United States would not be the capitalist engine that it is.

So, I give you the next portion of the retrictions and requirements per the Federal Drug and Cosmetics Act, Chapter III.

We left off at (h), which was basically “don’t claim it’s something you darn well know it’s not.”

Now on to i:

(i) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 404, or 721.

Don’t use labeling intended to trick the customer into thinking it’s something it’s not. This isn’t just about trademark violation; it’s also doing things like imitating the USDA Certified Organic label by doing something like creating a logo and font that says something like “USDA Certtified Organic.” Subtle differences to mislead will get you in trouble.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.

Don’t imitate other people’s trademarked products, either. And don’t even keep the stuff around that would help you steal their trademarks. It’s similar in thinking to posessing drugs versus posessing drug paraphernalia. Or, possibly more accurate, equipment that you could counterfeit with.

(3) [Relates to pharmaceuticals, so is not referred to on this blog]

(j) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of section 404, 409, 412, 414, 505, 510, 512, 513, 514, 515, 516, 518, 519, 520, 571, 572, 573 , 3 704, 708, or 721 concerning any method or process which as a trade secret is entitled to protection, or the violating of section 408(i)(2) or any regulation issued under that section. 4 This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

This will be another post altogether, but in a nutshell, if you find out a trade secret and you try to use it for your business and get caught, you’re in BIG trouble and could get your butt/your company’s collective butt dragged in front of Congress. And if you do get your butt dragged in front of Congress, you have to tell them ALL - trade secret protection gets revoked at that point.

(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

You can not “oops” spill coffee/trip with a marker/have a flamethrower accident that just happens to rub out the part of your ingredients label that mentions, say, arsenic. The label must be clear and easily read.

[(l) Repealed by Pub. L. 105-115, November 21, 1997 .]

(m) [not relevant for this blog unless you're taking body butter too literally]

¹

(n) The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with section 704.

You may not infer that the FDA has endorsed your product. The FDA is NOT an advertising tool, it is an adminstrative body, so find some other way to certify that your company is trustworthy.

(o) [not relevant for this blog]

(p) The failure to register in accordance with section 510, the failure to provide any information required by section 510(j) or 510(k), or the failure to provide a notice required by section 510(j)(2).

If there is information the FDA requires, provide it.

(q)(1) The failure or refusal to (A) comply with any requirement prescribed under section 518 or 520(g), (B) furnish any notification or other material or information required by or under section 519 or 520(g), or (C) comply with a requirement under section 522.

See above

(2) With respect to any device, the submission of any report that is required by or under this Act that is false or misleading in any material respect.

Don’t lie when you provide information.

(r) The movement of a device in violation of an order under section 304(g) or the removal or alteration of any mark or label required by the order to identify the device as detained.

If something was withheld for inspection, you’re not allowed to remove the inspected stamp.

(s) The failure to provide the notice required by section 412(c) or 412(e), the failure to make the reports required by section 412(f)(1)(B), the failure to retain the records required by section 412(b)(4), or the failure to meet the requirements prescribed under section 412(f)(3).

Do your paperwork, or the FDA won’t like you.

(t) [not relevant to this blog]

(u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).

Not following FDA regulations is considered a violation of FDA regulations. While I’ve never heard the defense “it’s not against the law to not follow the law!” I’m sure someone has tried it since the Louissiana Purchase.

(v) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413.
If a dietary supplement has bad side effects or is just bad for you, you can’t introduce it to the market.

(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 801(d)(3); the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 801(e) or 802, or with section 351(h) of the Public Health Service Act; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.

Indeed, lying to the government about your goods is a crime. Since what you don’t know really CAN hurt you - ergo, the Wal-Mart chemical burn fiasco of 2007 - tell the FDA what it’s asking you.

(x) The falsification of a declaration of conformity submitted under section 514(c) or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section.

More on “don’t lie to the government.” Perjury is always an ugly trial.

(y) In the case of a drug, device, or food –

(1) the submission of a report or recommendation by a person accredited under section 523 that is false or misleading in any material respect;

(2) the disclosure by a person accredited under section 523 of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or

(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this Act.

(z) 6 The dissemination of information in violation of section 551.

This just indicates that when it comes to giving your info, there’s a process and you MUST follow it. Per usual, bribes, threats, and giving up trade secrets without written consent will get you in big honking trouble.

1. image by Kapungo on flickr [↩]

While the FDA isn’t an enforcement body per se, it does have defined legal actions - and defined legal consequences- clearly outlined in the Federal Food Drug and Cosmetic Act. It even tries to cover up any loopholes, although I’ve found that the more you try to cover them, the more you wind up creating. But points to the feds for trying.

So here are the basics, with a few parts cut out because footnote chasing in excess of a very few drives me crazy:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

Don’t sell it if it’s not labeled right. In this case, adulteration could mean anything from adding something nasty because it’s cheap - let’s say, you substitute shea butter with nice, cheap, pork fat - and then you label it as vegan. Then, it’s adulterated AND misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

Doing the above, and selling it across state lines. So if someone bought my pig-fat shea butter on Etsy, and I sent it to them in Illinois, or wherever that person lives.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

If you’re a retailer, and you accept the mislabeled pig-fat shea butter mix, you’re in trouble too. You’re liable even if you don’t know it’s mislabeled.

This goes directly into the whole “sometimes, we’re going to investigate” angle:
(e) The refusal to permit access to or copying of any record as required by section 412, 414, 504, 564, 703 or 704(a); or the failure to establish or maintain any record, or make any report, required under section 412, 414(b), 505(i) or (k), 512(a)(4)(C), 512 (j), (l) or (m), 572(i)., 2 515(f), 519, or 564, or the refusal to permit access to or verification or copying of any such required record.

If you have records about what you’ve bought or sold and what you put in it, by golly, you’d better show those records when an official requests them.

(f) The refusal to permit entry or inspection as authorized by section 704.
You better let the inspectors come in and take a look. I find this one strange, as it goes against civil rights regarding search and seizure, so I’m going to write my Congressperson about it. That’s hinky. The Bill of Rights should apply to civil and criminal action.

(g) The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.
You’re not even supposed to MAKE the bad stuff. And this isn’t just within the United States - this applies to US territories and protectorates as well. So if you’re on an army base, and you’re mislabeling your goods, you’re still liable.

(h) The giving of a guaranty or undertaking referred to in section 333(c)(2) of this title, which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in section 333(c)(3) of this title, which guaranty or undertaking is false.
100% natural - GUARANTEED! (And oh yeah, 90% of it is from chemically synthesized petrol). That would be illegal.

I know the FDA isn’t the stuff of excitement and intrigue. But it’s stuff you gotta know, because when they decide they’re going to enforce, they come down with an iron fist. Would it help you to know that histories of bribes and scandals abound there? Yes, there’s some serious passion beneath all that analysis of foodstuffs! OK, really, it’s because it’s possibly the most understaffed agency in US government and the corruption is nothing more than survival, but let’s just pretend it’s because there’s something steamier than hog manure going on beneath their government-issue desks.

((image by cottergarage on flickr))

Something to keep in mind: the FDA applies to whatever you decide to sell over state lines. What you sell within the state, however, is between you and your state legislature. Some states are so strict in their food and cosmetics regulations that they make the FDA look like a cute little agricultural think tank by comparison. So what you get from state to state will vary in the way it is monitored.

The requirements of the Food, Drug, and Cosmetic act are pretty simple, really: you can’t sell it if there’s something wrong with it, and you had better tell people what’s really in there.

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition–whether they result from ingredients, contaminants, processing, packaging, or shipping and handling–cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if–

• it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual [with an exception made for hair dyes];
• it consists in whole or in part of any filthy putrid, or decomposed substance;
• it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
• its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
  except for hair dyes,
• it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)

Sounds complex, doesn’t it? It’s not.

• it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [with an exception made for hair dyes]
  If it will injure the user, you don’t get to bottle it up and sell it. Except for hair dyes - some injury is considered par for the course with that stuff.
• it consists in whole or in part of any filthy putrid, or decomposed substance;

If it’s rotten, rancid, moldy, or otherwise gross, you’re not allowed to sell it for people to rub on their faces.

• it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

While this isn’t requiring lab conditions necessarily, you are expected to make stuff so it’s actually clean by somebody else’s standards.

• its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health
  The packaging should not endanger the user, either.
• it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)
  Buyers like pretty colors but adding some pretty colors to cosmetic products are poisonous. The FDA has a specific list of what those particular dyes and additives are.

I think that a lot of people just wander around on hearsay about what is and isn’t allowed by the Food and Drug Administration in the US. And to be fair, they’re a seriously understaffed government body that sometimes overregulates because they just can’t track who was doing what when the inevitable turnover happens in an agency that overburdened. Still, they do make plenty publically available, although all in long, boring, legal terms.

So let’s start with the basics: the FDA defines cosmetics as ” (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”¹

((Painting: Governors of the Wine Merchant’s Guild by Ferdinand Bol))

For those who shorted out at the word articles, here’s the paraphrase:  Soap is not a cosmetic. But anything else you put on your body that either cleanse you, beautifies you, makes you prettier or alters your appearance (because the feds don’t like acknowledging uglifying products), then guess what? It’s a cosmetic. If you’ve got something that multitasks by combing your hair and then spreading hair dye in it, that’s a cosmetic too. Except soap. Soap isn’t a cosmetic, it’s a social requirement.

So if you go outside and rub mud on yourself in a rainstorm, the FDA will want to regulate that if you try to bottle the mud and sell it.

1. Federal Food Drug and Cosmetic Act Chapter 2 [↩]

The Independent argues the ineffectiveness of herbal treatment.

I’ve learned that I have to take British journalism like I do US-based journalism, on a case-by-case basis. Still, despite the severely slanted nature of nearly all Western press, I really think that British ”objective” journalism is much more prone to smug pandering and deliberately bad information, whereas US journalism bad reporting is the result of either sloppiness or lack of time for fact checking. (Brits do it out of mean spiritedness, while the US does it out of ignorance. Equally bad, IMO). The above article is one of those examples.

The slant is that “herbs don’t really work.” But when you delve into the details, that’s an inaccurate conclusion.

Says one passage of the article:

In the first systematic review of individualised herbal medicine – the sort where a customer goes into a herbalist’s shop, describes their symptoms, and the herbalist then makes up a preparation of several different herbs – the two researchers found no evidence that the complex Chinese, Ayurvedic or western European potions worked. Of 1,300 studies that they were able to locate, only three were randomised clinical trials comparing the herbal preparations with placebos. Of those three, two found that the individualised preparations were no better than placebos, and the third – of patients with irritable bowel syndrome – found that they were less effective than the standard herbal treatment, a mixture of 20 Chinese herbs. The results are published today in the Postgraduate Medical Journal.

Professor Ernst, a professor of complementary medicine who has been a thorn in the side of the alternative medical lobby, argued that the findings demonstrated that medical herbalists could no longer claim that their tailored remedies worked. What astonished him, he said, was the failure of the herbal medicine establishment to respond to their request for evidence. “We wrote to 15 professional organisations asking if they had any evidence and they came back with nothing. That was the most amazing thing for me,” he said.

First, notice the language: rather than “remedies” the writer opted for, in this context, the derogatory term “potions.” Second, there is information missing: where were those 1300 studies pulled from? And why aren’t there more genuine clinical trials of herbs against placebos?¹

Also, notably, while Ernst, the person opposed to use of herbs in place of traditional treatment,² there are scant quotes from an herbalist and none from an Ayurvedic expert, instead the author is choosing to use vague terms like “they.” There are thousans of herbal types in the US, Canada and the UK - even if the reporter couldn’t get one on the phone, a request or two in a few Internet forums should at least have gotten an email quote. So hello, irresponsible.  Particularly considering that there is a massive difference between Estern and Western herbal practice.

While it does conclude with a list of herbs considered “safe” per clinical trials, there are no links to those clinical trials, and it still ends on the isolated cases of poisoning/inaccurate treatment. Consumers face a barrage of information ever day, and it’s gotten far too easy to let the government do the thinking, especially when it comes to chemicals, whether herbal or synthetic. Unfortunately, since 100% of everything around you has a chemical composition, you’ve got to think about it. Not all herbs are safe - but contrary to the way this article is written - not all herbs are dangerous, either. Point of fact, one of the “safe” herbs, valerian, does have significant risk associated with its use since it’s the base ingredient for Valium³.

I will never be convinced that herbs don’t work, having used them for most of my adult life, and considering that “herbs” are the chemical foundation of the pharmaceutical industry. Especially after this latest bug that I’ve had for 6 weeks now - my doctor gave me Robitussin with codeine (why would I need codeine!!!???) and sent me home. The Robitussin did not work. Since there are plans afoot for removing nearly all cough remedies from the shelves⁴, this leaves me herbal remedies only since my doctor wouldn’t do a damn thing - and now that I’ve started taking herbs for the hideous cough befouling my life, it’s stopped making me miserable.

An intelligent article on the subject would have:
1. Quoted the studies, and named said studies
2. Asked why there are so few studies
3. Stayed away from the “ooh, magic spooky people!” language. Yes, a lot of us herbalists are Wiccan. Suck it up and get over it, these days that’s only interesting to the complete twit. There’s a whole lot of Christian/Foxfire type herbalists around, too.
4. Spoken to a Real Live Herbalist rather than lumping all herbalists into a group and calling it “they” and “them.” It’s Us versus Them. Oh Noes!!!!⁵
5. $20 that Jill Davies, head of the Association of Master Herbalism, was misquoted and then some. Why save her until the last paragraph unless you’re manipulating information?

1. Notably the author of this article completely overlooked that most pharmaceuticals are developed from extracts of the same plants used in common herbal treatments. [↩]
2. Magickal Realism advocates getting appropriate medical care from a licensed professional. We really believe herbs and snotty doctors can someday work together, once the doctors get over their politics and start caring about their patients again. [↩]
3. aka Dizepam [↩]
4. 10 stupid kids a year get high on cough syrup, so they ban it. Thousands die per year because of cigarrette smoking, and it’s still out there. [↩]
5. mocking. sarcasm. [↩]