W

ASHINGTON — Case 7682299: Aug. 1, 2010. A mother gives her toddler three homeopathic pills to relieve her teething pain. Within minutes, the baby stops breathing.

“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” the mother later told the Food and Drug Administration. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”

The company, Hyland’s, promotes “safe, effective, and natural health solutions” that appeal to parents seeking alternative treatments. But the agency would soon hear much more about Hyland’s teething products. Staff at the FDA would come to consider Case 7682299 one of the luckier outcomes.

A review of FDA records obtained by STAT under the Freedom of Information Act paints a far grimmer picture: Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital, where emergency room staff tried to figure out what had caused their legs and arms to start twitching.   

Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. Agency records show eight cases in which babies were reported to have died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.

(The agency is also investigating two other deaths tied to teething remedies but declined to confirm the manufacturer of the products or provide the case reports.)

Following an FDA warning in September, Hyland’s said that it would no longer manufacture the teething products. But they remained on some store shelves for months, and are still available on the internet. They likely continue to be used in homes nationwide.

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Hyland’s, a 114-year-old private company based in Los Angeles, is the nation’s largest homeopathic business. It insists its products are safe and says the FDA has failed to show there is a scientific link between them and infant seizures or other complications.

“That doesn’t mean that children don’t have a sensitivity to a product. There is a lot of sensitivity on kids’ parts and we have to watch carefully,” said a spokeswoman, Mary Borneman. “It’s not something that condemns the entire product line.”

Behind each of the FDA case numbers are angry and, in some cases, heartbroken parents. But a STAT examination — and the first detailed look at the case reports — also raises questions over the response of regulators.

It took four years until the FDA pushed Hyland’s to reformulate its remedies, in 2010. In the seven years since then, there has been a steady stream of reports of adverse events tied to Hyland’s homeopathic teething products.

“The FDA could bring the hammer down on them,” said Sarah Sorscher, an attorney for the nonprofit Public Citizen Health Research Group. “But it doesn’t. At the point where you have infants being hospitalized and deaths reported, it’s simply not acceptable for the agency to delay in taking action.”

An FDA spokeswoman defended the agency’s handling of the matter.

“It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product,” the spokeswoman, Lyndsay Meyer, said in a statement.

Despite the FDA’s difficulty in proving Hyland’s products harmed children, some doctors had no doubt.

In case 462749, dated Sept. 15, 2011, a physician sent Hyland’s a handwritten note, stating his patient, a 5-month-old girl, was unresponsive for 45 minutes after taking its teething tablets.

“I am sure this was not an allergic reaction,” he wrote. “I would like you to report it, find a contact at the FDA, so we can start an investigation and pull this dangerous, unregulated product from the shelves.”

One mother wrote the company to say her son’s pupils dilated “like marbles with big black eyes.” Another described seizures her daughter continued to have after taking the tablets and told the company, “I hate hate hate u for this.”

Teething Tablet

An industry giant in a giant industry

Hyland’s and its parent company, Standard Homeopathy Co., are considered major players in the homeopathic market. CEO John P. Borneman comes from a family that has been in the business for generations, and is president of the industry group that publishes the Homeopathic Pharmacopeia, a compendium that serves as the bible of the industry.

The company sells dozens of products for pain relief, stress, sleep problems, allergies, flu, and other maladies.

As with all homeopathic treatments, Hyland’s products are based on a theory that patients can benefit from highly diluted natural substances that, in their original form, might make people sick.

Despite a lack of scientific evidence that homeopathic remedies work, they are ubiquitous.

Homeopathy has become a multibillion-dollar industry. Its products are big sellers around the world, and popular with adherents from Cher to Prince Charles. The industry also has political clout: It has been able to exempt itself from many rules proposed by Congress and the FDA over the years.

Unlike pharmaceutical company-produced drugs, homeopathic products don’t have to prove that they are effective at treating anything in particular before going on the market. It is left to the FDA’s drug division to determine whether they are unsafe after they are on the market — a difficult task since the adverse event reports are generally considered to represent only a fraction of the actual incidents and may lack sufficient information to allow for thorough investigations.

“If I’m working in the emergency room and I have a family that comes in with a seizing infant, I may not have the wherewithal to get the history of homeopathic use,” said Dr. Edward W. Boyer, a toxicologist in Harvard Medical School’s emergency medicine department.

In some cases, parents assume that products described as natural remedies, as is the case with Hyland’s tablets and gels, could not possibly result in complications, and never mention their use to a doctor. Without sufficient evidence of a problem, the FDA lacks what it needs to use the enforcement tools it does have.

For Karinna Talbott, a 26-year-old mother in Colorado Springs, the fact that Hyland’s teething products were labeled “natural” made her lower her guard.

“When our fourth kiddo comes around and starts teething at 3 months, we were like, ‘OK, what can we do to give him some relief?’” Talbott said. “Someone told us about the teething tablets and we thought, ‘give them a try.’’’

Shortly after her son began taking the tablets, she said, his hands began twitching.

“We didn’t correlate it to the teething tablets,” Talbott said. “And his symptoms got worse, went to his arms and his feet. Sometimes they all happened together.”

Talbott said her doctor was at first uncertain as to the cause. But when they stopped giving him the tablets, the seizures also stopped.

“The neurologist said, maybe he was a little sensitive to the products in the teething tablet.”

Blaine Talbott
Blaine Talbott and his father, Joshua Talbott, in their home in Colorado Springs. Kirsten Leah Bitzer for STAT

‘Deadly nightshade’

In investigating Hyland’s teething products, the FDA focused on an ingredient known as atropa belladonna, an herb known colloquially as “deadly nightshade.”

In diluted form, the substance is not expected to pose any health risk. In 2010, however, FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of atropa belladonna in its products.

The agency issued a public warning, noting “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”

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It also noted that “infants are very susceptible to the neurotoxicity of drugs” because of how the body distributes and responds to drugs, and noted that “absorption of belladonna from the skin and mouth was fairly rapid.”

The company voluntarily took the products off shelves and agreed to reformulate them, although it insisted they were safe.

“We felt it was the right thing to do so that parents didn’t have to be concerned about the product,” said Borneman, the spokeswoman.

But the number of serious adverse events tied by the FDA to the products kept climbing. Some pediatricians and neurologists concluded the tablets and gels were the cause. Many parents wrote to the FDA, accusingly, asking why the pills were still on the market.

“My son had 3 of Hyland’s Teething Tablets,” a mother told FDA on Feb. 13, 2012, noting that the product appeared to have caused several seizures. “I am shocked at the popularity of this product, which is growing, and the lack of knowledge among parents, as well as the lack of warnings on the labels. Parents desperately need to be warned about this product if it is going to stay on the shelves!!!! Please do something!”

In September 2016, the FDA announced that it was investigating more adverse events reports and recommended that consumers stop using Hyland’s and other homeopathic teething products and dispose of any in their possession. Some stores, including Target and CVS, which sold Hyland’s and other homeopathic teething products, pulled them in response.

The FDA also asked Hyland’s to recall its products again. But this time Hyland’s stood its ground, and the agency has no authority to enforce a recall of homeopathic products.

Borneman said the company’s “pharmacovigilance program,” a product safety review system launched after 2010, offers proof that the treatments are safe.

“Homeopathic medicine has a very large margin of safety,” she said. “Our testing ensures there’s not too much belladonna in any bottle” of tablets.

At the same time, the company decided to stop manufacturing the teething tablets. In an open letter to customers, Hyland’s said the FDA warning had “created confusion among parents.”

“Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA,” the company said, while insisting Hyland’s products, “including those you already have, are safe for use.”

Several weeks ago, on Jan. 27, the FDA issued another warning, saying that laboratory analysis of Hyland’s teething tablets found levels of belladonna “sometimes far exceeding the amount claimed on the label.” The agency warned consumers not to use the products and to seek medical care immediately if their child has seizures, difficulty breathing, lethargy, muscle weakness, or other problems after using homeopathic teething products.

The FDA also said there was no evidence that they actually worked.

Teething Tablet doc 2

Cracks in the FDA’s authority

With concerns about toxic levels of belladonna, and the sheer number of cases of adverse events, some critics — and parents — say the FDA should have moved faster in the case of Hyland’s.

But they also acknowledge that the episode underlines the cracks in the agency’s regulatory power when it comes to homeopathic products. There is no set mathematical formula or official standard that spells out how many sick or deceased children must be reported before the FDA seizes a company’s inventory or levies fines or shuts it down.

Critics say the fact that homeopathic products are generally highly diluted has kept them on the FDA’s back burner.

“It’s low on their priority list,” said Dr. Aaron S. Kesselheim, who coauthored a paper in the New England Journal of Medicine last year on the subject. “FDA for a long time just kind of deferred on homeopathic products because they are mostly inert and so diluted. The harm comes from people wasting their money, or diverting them from things that do work.”

In the case of some of Hyland’s products, however, Kesselheim believes that the toxic levels of belladonna show a substantial safety problem, putting a responsibility on FDA to respond.

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One problem the FDA has in doing so is a matter of staffing: The agency has a medical officer review each report from manufacturers, but it doesn’t have someone who can routinely follow up with the patient, the patient’s family, or physician for missing records necessary to take a serious enforcement action.

“Is it fair to criticize FDA for the time lag between 2010 and now?” says Patricia Zettler, a former FDA counsel and associate law professor at Georgia State University. “I think the agency is in a tough position, with these kinds of products and with adverse event reports in general. They are not necessarily a perfect indication of something happening with a drug.”

“That said,” Zettler added, “it does sound like this is a product the agency was concerned about. It’s tough to parse out whether two reports of seizures should have been enough, or three or 10. There’s a balance the agency has to strike between acting quickly on safety information and not overreacting to something that may not actually be caused by the product.”

Public Citizen’s Sorscher said criminal cases take years to pursue, so the FDA would much prefer voluntary compliance.

“They don’t have a mechanism to say, ‘this ingredient is unsafe, nobody should sell it,’” she said. “It might be time for Congress to give FDA a standard and say, you can issue a regulation saying no one can make it anymore.”

Outraged by the standoff between FDA and Hyland’s, Connecticut Democratic Representative Rosa DeLauro introduced a bill last week called the Recall Unsafe Drugs Act. The proposal would give the FDA mandatory recall authority over homeopathic products and drugs.

“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful,” DeLauro said, adding that the company “is choosing instead to prioritize the company’s profits and reputation before the safety of our children.”

“As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families.’’

For the parents of Case 10723317, any action would come too late. A mother reported that on July 9, 2014, her 9-month-old daughter died after being given two teething tablets, crushed, for the first time. She gave her infant the tablets, then a bottle, and then left her to sleep. When she checked on her 45 minutes later, she was dead in her crib, beside a puddle of vomit.

Five months later, after reading online reports suggesting babies may experience seizures after taking belladonna, she contacted Hyland’s.

“Customer did not request a refund or replacement,” noted the Hyland’s staffer who filed the report with the FDA. Hyland’s also noted that it was not able to test the bottle, because the customer threw it away.

“Due to the limited information provided by the reporter no further investigation is possible at this time of this incident,” the company concluded.

Ike Swetlitz contributed reporting.

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  • Ok, so the FDA can come down on a homeopathic “drug” for 10 deaths but not come down on vaccines that have much higher mortality rates? That makes no sense.

  • Homeopathic preparations should clearly be subject to the same regulations as medicines. They should go through pre-clinical(animal studies) and full clinical trials and before they are allowed to be sold to the public. This should be the case for each individual product.

    Clinical trial are in stages:

    Phase 0: trials on a small 10 to 15 subjects to confirm that the products interactions within the body appear to be as expected.

    Phase 1: trials on small group of subjects (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects.

    Phase 2: Testing with a larger group of people (100–300) to determine efficacy and to further evaluate its safety. The candidate product will often be tested against a placebo.

    Phase 3. Testing with large groups of subjects (1,000–3,000) to confirm products efficacy, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

    At this stage the product can be licensed for use.

    There should be ongoing Phase 4 studies once the product is in use to gather additional information, including products risks, benefits, and optimal use.

    There should as part of Current Good Manufacturing Practices be regular audits of Production records and spot checks on product containers and closures, including testing for microbiological contamination.

    The initial costs of the clinical trials would be met by the manufacturer and then passed on to the customer. Full clinical trials are expensive, though if at stage 2 it had not been possible to determine efficacy there would be little point in continuing as the product would not be approved.

    • Depends what you mean by “clearly should”; do you mean it in a normative sense or do you mean as an interpret’n of US law? If the latter, you’re probably wrong but there’s an argument that you’re right.

      Congress in enacting food & drug laws, and states in their pharmacy laws (mostly boilerplate), created a separate category generally called by analysts “official articles” that include drugs those articles specified by any of a short list of compendia which are maintained by private bodies. The major one is now called USP-NF, formed by the merger of two of them, and many government officials sit on their board, although it is still independent of direct gov’t control, although each was founded by gov’t agencies. The other, the Homeopathic Pharmacopeia of the US, was added to the federal statute by amendment in 1938, and these days I don’t know of any gov’t officials on the board of the Homeopathic Pharmacopoeial Convention of the US.

      In both federal & state laws, an article is defined as statutorily a “drug” if it EITHER fits a certain description of its “intended” use OR has a monograph in one of the compendia. So, for instance, cannabis today is no longer treated as a “drug” in US law because it was removed from the USP by their board’s convention. Nothing explicit in the statutes says something that qualifies as a “drug” by being an official article is not subject to the same provisions as an article of commerce that qualifies as a “drug” by the other statutory definition, so there are some who argue as you do that newly entered HPUS articles are apparently subject to the same provisions you listed above for “new drugs”.

      However, such has not been the case. When the safety and efficacy provisions of the drug laws were put in place, the general understanding was that the governing bodies of the official compendia were an adequate substitute for the advisory panels FDA convenes ad hoc to decide on licensing new drugs. It was not believed that the official compendia would be a major point of entry of new drugs, and indeed they have generally lagged behind FDA panels in their examination of articles. Not only that, but the overwhelming majority of new drugs has been proprietary, sponsored under a brand name, rather than as new compositions submitted generically, as they would be identified in one of the official compendia. Basically the bodies governing the compendia want to (always wanted to) see what gained & maintained acceptance by medical practitioners.

      In order for the HPCUS to have much to do these days, they’re forced to not limit themselves to looking at “new drugs” as introduced into the US market by other means, but to look at evidence from homeopathic provings as their trials. The inclusion of the HPUS in state & federal drug laws carries the implication that these will continue to go on outside of the channels used by “allopathic” drug development.

  • I’ve never had an issue with these with my son, who is now six. I find it a bit amusing that the FDA states this because of belladonna but laughs off people’s concerns about deadlier ingredients in vaccines and other drugs.

  • When my daughter took this product she almost died on my she is now 2 and has breath holding spells and they lead into seizures the doctors can still not tell me what causes them … she has to live with it for the rest of her life…

    • I have great sympathy for your daughter, you and your family. This must have been a terrible situation for you all. However, it is highly unlikely that any homeopathic medicine could have caused your daughter’s problems. The teething tablets contain two trillionths of a gram of substance. The FDA analysis found at most 53.4 billionths of a gram of substance in Hyland’s products. Neither of these amounts could possibly have any negative effects whatsoever. In fact, a child would have to ingest 12 bottles of tablets in order to develop even the most minor symptom of belladonna toxicity which is a dry mouth.

      Your doctor should be investigating other causes for her condition. The fact that a person has taken a drug and then become ill in no way assures that the drug was the causative agent. Perhaps if your doctor investigates more thoroughly he or she will be able to put a stop to her breath holding and seizures.

  • Korsakoff dilutions don’t enter into it. The Fluxion manufacturing method is deserving of serious criticism but also doesn’t enter into it. It is good to question the integrity of good manufacturing practices. However, historically, given the strictness of the rules and the simplicity of the protocols there have been fewer such issues by far than for any other type of medicaments. If the FDA had been doing its job they would have conducted inspection audits and the manufacturers would have readily complied.

    If there was some contamination or adulteration of the end-user product, the the homeopathic angle disappears. It then doesn’t enter into it. This all becomes like a bad batch of Greek yogurt.

    The incident evidence here deserves to be considered with respect but it is of very quality, carries little weight. Proper follow up should have been done. Details please. That this has not been done is most improper and raises the question of this all being a ‘staged’ event. I write as a licensed private investigator and science director. This stinks. All smoke, no fire.

  • For the longest time its enemies denounced homeopathy as totally ineffective, a placebo, incapable of effecting anything. Now hypocritically, critics have discovered that homeopathy is magically able to impart huge effects. But only to harm. So from being impossible homeopathy is now dangerous. But, if this stuff can do harm then it is not a reach to find it can do good. And those homeopaths have 200 years of positive clinical evidence to summon up.

    By the way do not image the few speculative notes by some pathologically hostile practitioners counts for anything. This is rotten forensics, absent method or standards. On such rubbish evidence one cannot build an entire scientific and regulatory regime.

  • ChristyRedd,

    That’s disingenuous to say the least.

    Adverse reactions to homeopathic medicines are possible if they are contaminated or adulterated for one thing. Many homeopathic medicines contain lactose. Admittedly, the amount would not bother most people with lactose intolerance. And as this article shows, contamination as a result of poor quality control is possible. I dread to think what might happen if nosodes or sarcodes were involved. Or toxins like Botulinum.

    Also, pretending that “aggravations” and the “healing crisis” are not side effects/adverse reactions is dishonest, if you assume that they are real things.

    You know as well as I do that J T Kent said –

    “If you see that a patient must go in twenty-four to forty-eight hours, and suffering, it is a delightful part of Homoeopathy to administer Euthanasia to arouse vital action suddenly and permit the patient to go.”

    Homeopaths regard Kent as almost as important a figure as Hahnemann, especially in the US. The meaning of this aphorism is very clear.

    • The meaning of Kent’s statement is that homeopathy can ease the fear some people feel when they are dying.

      It is disingenous of you to take advantage of how the English language was used in the 1800’s to imply that any homeopathic medicine can cause death.

    • That’s a very strange reading… The meaning of that aphorism is clear. If Kent had meant what you imply, he would have used very different words. Kent is clearly using the word euthanasia in the context of causing death to end suffering – rather than

      “The concept of euthanasia in the sense of alleviating the process of death goes back to the medical historian, Karl Friedrich Heinrich Marx, who drew on Bacon’s philosophical ideas. According to Marx, a doctor had a moral duty to ease the suffering of death through encouragement, support and mitigation using medication. Such an “alleviation of death” reflected the contemporary Zeitgeist, but was brought into the medical canon of responsibility for the first time by Marx. Marx also stressed the distinction between the theological care of the soul of sick people from the physical care and medical treatment by doctors.”

      In Kent’s time, there was an organised euthanasia movement in the US. The arguments were the same as used today. Attitudes towards euthanasia of US homeopaths of the time are not clear but Kent’s writings do contain mention of euthanasia.

      “What is more inhuman than to leave the suffering patient in his last moments to writhe in the agonies of dissolution, surrounded by weeping friends. The true physician will embrace the opportunity to exercise his skill at these moments. It has come to pass that I am invited frequently to stand at the bed of moribund patients, whom I never attended during their curable ills, and as many times do I thank the Grand Master for the wonderful means of allaying the pangs of the flesh, without resort to the necessity of departing from that homoeopathic law which I have so many times pronounced universal, even in the last moments–a euthanasia.”

    • Plain and simple: Homeopathic medicines are incapable of creating life threatening situations.

      “Skeptics” have claimed for years that homeopathy can’t possibly have any effects at all because it’s “just water”. In fact, “skeptics” have often stated that since homeopathy has no effects the only way it can cause harm is when someone uses it instead of “real”, science-based medicine. Now you want to spread the opposite misinformation about homeopathy by taking advantage of the FDA’s warning.

      You can’t have it both ways.

    • Plain and simple: Homeopathic medicines are incapable of creating life threatening situations.

      Would you say that withholding lifesaving treatment is, or is not, “creating a life threatening situation”?

  • I recently had an adverse effect to a homeopathic remedy. Rash, pelvic pain. The practitioner basically dismissed me. So I sent her this article. Of course adverse reactions are possible. I don’t understand why anyone would deny that. These are “medications” and should be wisely and with caution. And investigations should occur.

    • JoAnn,

      Is it possible that you are confusing homeopathy with herbal medicine or some other natural system of medicine? Adverse reactions to homeopathic medicines are NOT possible because most of them do not contain even one molecule of the original substance. It is not possible for less than a molecule of substance to create an adverse event. Large studies, replicated research, have proven that.

      This article proves absolutely nothing and will not change these facts about homeopathy.

    • Christine said:

      “Is it possible that you are confusing homeopathy with herbal medicine or some other natural system of medicine?”

      What’s natural about the way homeopathic products are manufactured? Or the ones made from microwave oven or mobile phone radiation? Or the ones made from synthetic drugs?

      “Adverse reactions to homeopathic medicines are NOT possible because most of them do not contain even one molecule of the original substance.”

      Except the ones that do – and I saw what you did there (“most of them do not contain even one molecule”).

      But then there’s things like this:

      “Q. Do homeopathic remedies have side-effects?
      A. Yes they do. It is a myth that there are no ‘side-effects’ with homeopathy.”

      http://homeopathyplus.com/q-do-homeopathic-remedies-have-side-effects/

      Then there’s homeopathic ‘aggravations’.

      “It is not possible for less than a molecule of substance to create an adverse event. Large studies, replicated research, have proven that.”

      Really? But please say what ‘less than a molecule of substance’ means.

      But if it’s not possible for a homeopathic potion to have an adverse effect, perhaps it is concomitant that
      it also cannot have a beneficial effect?

      But please provide links to these trials of which you speak that ‘prove’ your claim.

      “This article proves absolutely nothing and will not change these facts about homeopathy.”

      LOL!

    • Alan,

      When a lay person uses the term “side effect” he or she is thinking in terms of
      side effects caused by conventional drugs. Those side effects are actually diseases caused by the drug. Homeopathic medicines do not cause diseases. If you are now claiming that homeopathics can cause diseases, you are stating that they do have effects; that is, they are not “just water” as “skeptics” have claimed for so many years.

      The article you reference pertains to provings. What sometimes happens in practice is that a medicine will aggravate. As large studies show these aggravations are minor or moderate in nature, last brief periods of time and do not cause harm.

      http://homeopathyresource.wordpress.com/2009/01/05/extensive-study-concludes-homeopathic-remedies-and-treatment-are-safe/

      Read the body of the study. It references an earlier study which shows the same thing.

    • @ChristyRedd
      If the manufacturing process is poorly done, as in this case, and particularly as contamination must be almost inevitable unless the mixing vessels are replaced with each batch, what would be the effect in your view of getting a dose of the wrong homeopathic medication?

    • We don’t know that the mfg. was poorly done. It depends on their tolerances. And one of the accepted ways homeopathic attenuation may be done is by reusing the same container to do the serial dilutions by exploiting the carryover after emptying, known as Korsakoff potentization. It would be unusual to do an “X” (decimal) attenuation that way, but if the dilution is done that way, one would expect that over the course of serial dilutions, random or possibly systematic error could result in variation in final concentration that would span an order of magnitude or more.

    • We don’t know that the mfg. was poorly done.

      This is the logical conclusion of the findings.

      If it wasn’t done poorly it was done intentionally. Can you think of another option?

      While I don’t agree with the company’s choice of product I also don’t suffer from the delusional worldview that so many alt-med whackjobs subscribe to. Hylands, just like every other business in the pharmaceutical industry, wouldn’t have intentionally set out to harm their customers.

    • The option is as I explained: use of a mfg. method whose tolerances allow for the variation seen, because the product is still acceptable and safe.

    • The option is as I explained: use of a mfg. method whose tolerances allow for the variation seen, because the product is still acceptable and safe.

      That’s an assumption you made. Unless you can demonstrate that this is the case you’re doing little more than clutching at straws.

      Regardless, the dilution level at which the source material is detectable is far far less than that on the packaging (where there should be no possibility of detecting it at all.) So the thing in the bottle is not the thing advertised on the label/packaging. Also, from the principles of homeopathy it is far less powerful.

    • That’s not an assumption, that’s just an answer to the question of what the possibilities are, from the POV of someone experienced in the medical products industry and knows something of QC.

      Also, the labeling and potency of a homeopathic product does not necessarily correspond to the concentration of material in it, but to the process of dilution (called “attenuation”, or, paradoxically, “potentization”) it has gone thru. Even the word “potency” doesn’t have its usual pharmacologic meaning, for otherwise 10 times the dose of a 5X would have the same effect as a dose of a 6X.

    • The option is as I explained…

      That’s not an assumption, that’s just an answer to the question of what the possibilities are

      You seem fixated on this one despite you later add that it’s one of a range of possibilities. My comment on you making an assumption was in the context of you focusing on just one of these things.

      Regardless, if the “tolerances” are such that what ends up in the bottle does not reflect what is on the label that is still a shoddy process and/or QA.

    • Then you didn’t read what I wrote about Korsakoff attenuation: that its labeling is as to the process, not to the amount of material that results. It has undergone the process n times; doesn’t mean you can exactly calculate the amount remaining by knowing n.

    • Then you didn’t read what I wrote about Korsakoff attenuation: that its labeling is as to the process, not to the amount of material that results. It has undergone the process n times; doesn’t mean you can exactly calculate the amount remaining by knowing n.

      I read it, but it doesn’t matter.

      You’re initial point:

      We don’t know that the mfg. was poorly done.

      You have started by conceding that we don’t know something. You have then gone on to add something to one of the possible options that are available without first establishing that this is the correct option.

      You’re adding crap on possibilities.

      Until it is established to be true that the manufacturing process was or was not poorly done adding more assumptions on top of assumptions is just pointless.

      Like homeopathy.

  • Alan H – Because of the danger of aspiration or choking, it’s recommended that babies never be left alone with a bottle propped up for drinking (with no adult supervising). See this from the American Academy of Pediatrics: https://www.healthychildren.org/English/ages-stages/baby/feeding-nutrition/Pages/Practical-Bottle-Feeding-Tips.aspx While it’s not entirely clear that this is what was done here, from the description in the article it sounds like this was the case.

    • Betsy

      I have no reason to doubt that is a cause of death of some infants, but that was not something I was asking about. You claimed:

      “Also, I’m very sorry about the baby who died, but it’s considerably more likely that the baby died due to being left alone with a bottle (and then vomiting and aspirating), than that the vomiting was due to a homeopathic substance.”

      It was your claim that “it’s considerably more likely” that I was asking about.

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