The Zicam issue brings to the fore yet another issue involving the mandate of the US Food and Drug Administration (FDA), the federal health regulator that has jurisdiction over medical devices and medical drugs—and food. A wieldy mandate indeed and one that, due to funding and staffing issues, the agency has been hard-pressed to undertake effectively.
That said, naturopathic products, natural-health potions and homeopathic elixirs do not fall under the FDA’s regulatory mandate for approval.
Given the growing popularity of homeopathic products, the FDA’s mandate should be expanded.
“Many of our clients believed the FDA had evaluated Zicam before it reached the market,” said lawyer Robert Gordon, a partner with the New York law firm Weitz & Luxenberg. “In fact, Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural ingredients. Mounting evidence from the scientific community is proving Zicam with zinc should never have been sold. Some trusting users are now paying a price with their health.”
The status quo only confuses the public. To be fair, nowhere on the labels for products such as Zicam does it say that the product carries FDA approval. And yet, when there is a problem with a product—homeopathic or otherwise—which agency undertakes the issue of the health alert?
The FDA. The latter is also involved in the negotiation and co-ordination of voluntary product recalls—as it was for Zicam—for products the FDA was not required to approve. That, together with the blurring of the lines between what is medicinal and what isn’t, leaves Joe Q. Public at a loss to explain just who is running the show.
The same holds true for dietary supplements and other weight-loss remedies that use natural ingredients. If it’s homeopathic, then a product does not have to satisfy the FDA before it goes to market.
But here’s the rub: various medicinal ingredients, either on their own or in concert with other ingredients, can elicit side effects and other dangerous risks. Hence the requisite testing required of the manufacturers, with the subsequent vetting through the FDA before the product is approved for sale.
However, just because an ingredient is listed as ‘natural’—a mineral, herb or otherwise—doesn’t automatically suggest it is safe. Natural products can hurt you too, if used in the wrong way and in misguided combination with either another product or in association with an incorrect indication.
People who have used Zicam nasal spray for colds have reported a loss of their sense of smell. Sometimes it is immediate. For others the loss occurred after prolonged use. Some had their sense of smell return after they stopped using Zicam. Others are fearing that their smell loss (and concurrent loss of the ability to taste food) may be permanent, and lawsuits have been launched.
All, because of zinc. Zinc on its own has a benefit to the human body. It’s actually integral, in proper balance with copper, to maintaining a healthy system. However, zinc up the nose is apparently a problem, as various studies and a flood of reports to the FDA now show.
Would this have happened, had this product been required to go through the rigorous FDA approval process?
The FDA is under the gun due to the perception of lax oversight. The agency’s critics cite too many close ties, funding and otherwise, with pharmaceutical companies that only serves to cloud its objectivity. Defenders of the FDA cite the fact that the agency has suffered through years of chronic under-funding and staff shortages and thus cannot hope to cope with a regulatory environment that now sees drugs and medical devices increasingly manufactured offshore.
And now this.
The FDA needs to promote to the American consumer that it does not have jurisdiction over homeopathic products—at least at the approval stage—and therefore the consumer cannot assume that a homeopathic product he is buying comes with the FDA stamp of approval.
Either that, or Congress needs to provide a massive funding and staffing boost to the FDA in order to undertake its current mandate, together with the adoption of a new mandate to regulate the homeopathic industry.
The FDHA—the US Food, Drug and Homeopathic Agency.
Has a nice ring to it.
Well, to be fair, Zicam is NOT EVEN a homeopathic product! This is a serious problem with the position in this discourse, do you not know what homeopathy is? Of course you don't because no matter what name calling the Zicam product is using…..it is definetly not homeopathic. The product is one of those shotgun remedies with a little of this and a little of that but NOTHING of that concoction is homeopathic, classical or otherwise. We don't need the FDA, another harmaceutical companiy that is never a problem that money can not handle………to be now, taking on additional responsiblities (especially when the FDA ran to the Obama transition team in advance of the inauguration, telling Obama that the FDA was corrupt…..and inept!). Zicam is not a homeopathic remedy classical or otherwise, so please, get your facts straight ESQUIRES before you start trying to direct traffic in a country whom you do not even know the driving laws!
Sincerely,
Dr. Jordan
Hi Dr. Jordan, Thanks for your comment; I agree that the definition of "homeopathy" and "homeopathic" have taken a beaten over the past couple of decades–and they've become inappropriately intertwined with "natural" and "holistic" as well. It is for this very reason that we feel some oversight would be a beneficial. I'm intrigued by the work you're doing–in bringing homeopathic medicine into the realm of your veterinary practice; it is not a blend of studies one sees too frequently. In regard to Zicam, we are only reporting the use of "homeopathic" relative to the nasal cold remedy based on what the makers of Zicam profess themselves; as published on their site on 6/30/09 in response to the question of whether Zicam is homeopathic, read on:
Regarding questions from consumers as to whether Zicam Cold Remedy products are really homeopathic, let me simply state, yes, they are. If you read the packaging on our Cold Remedy products, you’ll see that the active ingredient is a compound called Zinc gluconate. This compound is listed as a drug in the Homeopathic Pharmacopeia of the United States (HPUS) (a compendium of the FDA). To be clear, this ingredient and its concentration in Zicam intranasal Cold Remedy products are in compliance with this reference guide. Zicam intranasal products are labeled, marketed and sold in accordance with the Homeopathic Pharmacopeia of the United States and the Federal Trade Commission.
Due to the confusion, misclassification and misinformation consumers find on their local drug store shelves relative to any product marketed as "homeopathic", "holistic" or "natural", there should be some oversight to minimize misuse–or at the very least, provide some clarity to the purchase decision process. The FDA may not be the organization to best handle this, however at present, they seem the logical choice. And while we do not advocate a "big brother watching" or added-red-tape scenario that runs the risk of hindering progress in these fields, one can only think that the benefit of oversight/regulation would outweigh any negatives for consumers, the respective industries, and the practitioners.
Oh, and with regard to your closing comments–thank you for bringing the word "esquire" back into the lexicon–it sadly is not used that much in the US anymore. In reality, none of us at LawyersAndSettlements.com is an attorney–sort of a separation of church and state thing, if you will; we do, however, drive in the good ol' US of A and, as such, are all quite aware of the nation's driving laws.
In due respect, Dr. Jordon is wrong. I do not know how or why she makes this statement, but it is not factual.
Legally, Zicam IS a homeopathic medicine, but it is in a dose that is called a "low potency" (which means that it has not undergone many dilutions). Actually, Zicam has undergone many high quality double-blind and placebo controlled trials in the treatment of the common cold, and most of these trials have found positive results (it is strange that so many media reports have omitted this fact, even though anyone can google information about these studies). However, the dosage form in which Zicam had a problem was a very unusual method of placing the medicine on a q-tip and inserting it directly in the nose (no other homeopathic medicine has ever had that delivery form, as far as I know). This dosage form possibly increased the chances of problems from it.
The fact of the matter is that homeopathic medicines have a stellar history of safety. Anyone who says or suggests otherwise is playing loose with the facts.
Hi Dana, Thank you for your comments and perspective. Perhaps Dr. Jordan will respond here, as I'm interested to hear her perspective–particularly to your reference of Zicam being "legally" homeopathic. Still, aside from this debate (if there is indeed one), is the question of whether this class of medications should fall under the watchful eye of the FDA…
I am under the impression that the FDA's current position is that Zicam spray with zinc could not be sold without testing to demonstrate its safety and effictiveness because the homeopathy exception did not apply. At least one homeopathy group tried to distance itself from the recalled nasal spray. Following the FDA issuance of a warning letter to Matrixx Initiatives last June, Bloomberg's reporting on Matrixx's exploitation of the homeopathic medicine loophole in the Food, Drug and Cosmetics Act noted that the company's claim its intranasal products qualify as "homeopathic" is, at least, questionable:
"Zicam's recall has raised concerns among homeopathic industry officials. According to [Homeopathic Pharmacopeia Congress of the United States spokeswoman Mary] Borneman, the Zicam nasal products, because the medicine is inserted into the nose rather than taken orally, doesn't meet the guidelines of the homeopathic congress. Applying zinc in the nose hasn't been tested by the industry group, she said." See <a href rel="nofollow"> <a href="http://;http://www.bloomberg.com/apps/news?pid=20601109&sid=aUjZT68DlqiI” target=”_blank”>;http://www.bloomberg.com/apps/news?pid=20601109&sid=aUjZT68DlqiI.
There is NO debate on whether Zicam is a homeopathic medicine; it is! Some homeopaths have their own definition (and desires) of homeopathy, but they do not understand legal issues. However, Mary Borneman is absolutely correct on the usual appication of this medicine into the nose.
By the way, the TITLE of this article is deceiving because the FDA is (!) already in charge of regulation of homeopathic medicines. In fact, if you ask a homeopathic manufacturer, they will tell you that they are inspected regularly without notice.
Dana–wanted to get back to you re: your latest comment–you are right when you say that the title of the blog is a bit misleading. Titles and headers are a generalized summary of the content. If they were specific, they would be sentence-length.
As for the FDA, I was careful to make the point that the FDA is not involved in the approval process of these products, but that the agency's involvement comes into play when there is a problem. The FDA's own website states that the manufacturer is responsible for assuring that the products are safe before they are brought to market.
Also, the FDA refers only to dietary supplements. Nowhere–at least that I could find–does the site make any reference to homeopathic products. It would be helpful if it did.
The point I was making in the blog was not to slam homeopathic products. My own mother-in-law is a sound believer in them. Rather, I was trying to make the point that all products that are used…..ingested into the stomach, put onto the skin and thus absorbed via transdermal absorption, or put into internal cavities such as the nose and sinuses should be regulated by the FDA at the approval stage as well.
It's one thing for Grandma to prescribe a potion that she swears works and has been in the family for years. It's quite another to bottle it, market it and sell it. Grandma's potion is probably–like most homeopathic remedies–wonderful stuff, and is an alternative to putting unnatural chemicals and drugs into your system. I try to avoid drugs like the plague, personally and even try to avoid taking painkillers for headaches.
That said, the public has a deeply-rooted assumption that anything sold in a store, on a shelf with a label is safe and has been approved by some overseer. With homeopathic products, that is not the case….save for the manufacturer who, granted, has a reputation staked to the product.
However as homeopathic and naturopathic products become increasingly popular, it invites anyone with dubious intent to make a fast buck by putting something out there that could prove harmful, collect their money and scram. Nothing against the homeopathic and naturopathic industry, that for the most part exists to genuinely help humankind and is not in this simply for profit. But bottom line, in my view, is if it goes IN you, ON you or UP the nose and is SOLD by somebody….the regulatory oversight should extend, by the FDA, to the approval stage.
That's all. – Hunter
The FDA shouldn't even be in charge of anything. What a waste of Government money I wouldn't trust the FDA, CDC or any branch of our government wake up. These government agencies are full of fraud and disception. They are allowing the drug companies to poison us. They have allowed GMO's in our food supply.
chemicals and poisons in our water. What a freakn bunch of crap.