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]
(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.
