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Monday, October 25, 2010

Big Pharma strikes out at Hylands

Hyland's Teething Tablets

On the 23rd of October, the FDA made the grand sweeping announcement that it was recalling Hylands Teething tablets.  Within an hour of this announcement making an appearance on Facebook I was bombarded by questions from several people. 
At first I was shocked and worried that it was a case of contamination with some terrible biological buggy or something equally horrifying- I mean, I'd given my 8 month old son 2 of Hylands Teething Tablets just a few hours before reading this news.  I quickly went directly to the FDA website to read the information, and immediately sighed in relief.  No danger- just the usual meddling by the FDA and Big Pharma into the business of the little guy.

But I'm really pissed about this now!!!  What if this puts Hylands out of business?  What if the FDA manages to have the teething tablets banned?!?  Now what the hell are we suppose to give our poor teething babies?!

Let me back up for a moment.  Do you know what "Hylands Teething Tablets" are?  They are a homeopathic remedy for ... you guessed it: teething.  They are an awesome product that I have used on all of my kids when they were cutting new teeth. (along with another homeopathic product by Boiron called "camilla"). To read more about Hylands homeopathic preparations for children you can visit their website.

In response to the FDA announcement Hylands has made this response:

Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process
Los Angeles, October 23, 2010 – Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.
The Hyland’s Teething Tablets UPC codes included in the recall are:
1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.
After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.
In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.
Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.
No other Standard Homeopathic Company products are affected by this recall.
Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at
With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit or
About Standard Homeopathic Company
Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland’s brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté, Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family.

Dr.Iris R. Bell, MD PhD  writes about Hyland's Teething Tablets Safety Information HERE

I wrote my own letter to  Hylands and will post their response here when/if I get one.

So, they (the FDA and Big Pharma) are forcing the recall of a natural homeopathic product... big shock.  Big Pharma doesn't want anyone using an alternative therapy and especially doesn't want us to useing a product that they are not making money off of. 

But Heidi Stevenson of Gaia Health writes it all out for us in her excellent article 

FDA Bans Hyland's Homeopathic Teething Tablets

The FDA is stealing your right to use safe products. Remember, the FDA says you have no right to health—and they mean it.

by Heidi Stevenson

The FDA's goal of making the world safe for Big Pharma is made obvious by their attack on a product for which the possibility of harm is so far-fetched that it's laughable: Hyland's Homeopathic Teething Tablets. Well, it would be laughable if it weren't for the fact that an exceptionally safe product that's been used by thousands to ease their children's teething pains is now gone.
I was alerted to the ban on Hyland's Homeopathic Teething Tablets by JacQue Hawkins-Howard, who hoped that it wasn't true. Sadly, it is. JacQue's unsolicited testimonial for the product—"I use Hyland's products and their teething remedy. It was wonderful!"—isn't the FDA's concern. Their concern is that safe and effective products like it interfere with the sales of pharmaceuticals and the profits of doctors, because they don't see as much money from JacQue and other patients who successfully manage their own health.

Proof of the FDA's Dishonesty

In its attack on Hyland's, the FDA clearly stated:
The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy.
So, without any proof of any sort—not even an attempt to find any proof—the FDA decided that Hyland's Teething Tablets should be banned. They don't even provide any estimate as to the amount of the product that would have to be ingested to cause harm. That, of course, is because they don't care.
Not one shred of evidence is given that the product is dangerous, which isn't surprising, because it would take an incredible quantity to cause even the mildest adverse effect. Yet, the FDA panders to fear by suggesting that parents consult with a "health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.
They imply that children have been harmed because they've "received reports of children who consumed more tablets  than recommended". Notice that they don't say how many, nor do they even try to indicate whether they've found any connection between the tablets and the possible symptoms. Here's why:
It would take ingestion of at least a thousand tablets by a ten-pound child to see even the first hint of a negative response. That's at least six bottles—and even this is an extremely conservative figure.

The FDA's Targeting of Belladonna

Many pharmaceuticals utilize a Belladonna derivative, atropine, as an antispasmodic. A typical potency is 0.4 - 0.8 milligrams per pill(1). In this form, it can be effective, but it also carries serious risks. In contrast, the amount of Belladonna in the Hyland's formulation is a mere 0.0002 milligrams per pill. A single pill of the pharmacy formulation is 2,000 to 4,000 times stronger!

Hyland's Homeopathic Teething Tablets Ingredients

Here is the full list, quoted from Hyland's website, of the banned product:
Formula: Calcarea Phosphorica 3X HPUS - supports dentition
Chamomilla 3X HPUS - for irritability
Coffea Cruda 3X HPUS - for wakefulness and diuresis
Belladonna 3X HPUS (0.0003% Alkaloids) - for redness and inflammation
In a base of Lactose (milk sugar) NF.(2)

Available in bottles of 125 quick dissolving tablets.
Calcarea phosphorica, Chamomilla, Coffea cruda, and Belladonna are all homeopathic preparations in the 3X (US scale) homeopathic potency. That means they have been diluted so that there is less than 1 molecule of each substance per thousand molecules of the solvent—and they're even less concentrated in the final product.
All of these ingredients, when taken at a high enough dose, can be poisonous. However, at this homeopathic potency, any suggestion of poisonous qualities is beyond absurd. One is more likely to die from drinking too much water than to suffer the tiniest amount of harm from this teething remedy.

FDA's Methods

The FDA's first method is intimidation. In the case of Hyland's Teething Tablets, they simply issue a warning to the public. They claimed that the product contains a "potentially toxic" agent, implied, without evidence, that it has caused harm to children, and claimed that an inspection showed "substandard control of the manufacturing operation", though they don't say what was wrong.
Most companies cannot afford the costs involved in fighting the FDA, so most do what Hyland's has done: They acquiecse. Naturally, they're hoping that will be the end of it—but history has not shown that to be the case. As has been happening to raw milk producers and distributors, once the FDA has you in their sights, your chances of survival are slim.
That, of course, is why the FDA goes after small companies and single products. For the most part, each action manages to slip under the public's radar, and most companies simply don't believe that they could be the next target. As a result, a mass movement against the FDA hasn't started...yet.

Another Attack on Your Health Freedom

Obviously, this is yet another attack on your health freedom. The FDA is targeting individual companies, picking them off one by one. Your health is the last thing on their agenda.
If your health were their concern, the FDA would go after the makers of products like the fake butter flavoring of most popcorns, which causes brochiolitis obliterans, a disease that steals people's breath, in employees of factories that make it. They took months to take any action against the battery egg manufacturers who poisoned dozens, and those two companies are still practicing without obstruction.
Instead, the FDA goes after raw milk and a harmless homeopathic compound that soothes teething babies and eases the stress it causes their families. There can be no doubt that the FDA is serving its masters, Big Pharma. The idea that the people are their masters is just so...quaint.

HERE to read the article on Gaia Health's website