FDA Enforcement Letter Indicates Our Freedom to Choose has been Further Eroded

Last summer I wrote a blog post about small natural health companies needing to exercise caution with social media because of how normal interaction between company and customer, can be viewed as a medical “intended use” for your product.

Regretfully not everyone is privy to the latest tactics of the FDA and their international counterparts. In a warning letter to a manufacturer of a natural cough syrup, the FDA revealed the following:

·   Positive health-related comments from customers are considered intended use claims. (Cure, mitigation, treatment, or prevention of disease)

·  When the company “likes” a customer comment, it is further evidence of the product being a drug or device.

·  The company’s website may be free of any claims, but if the company’s social media is linked to the company website, and any of the social media sites contain the above two points, it is considered the same as making the “claims” on your own website and more evidence that will be used by the FDA.

Here is the link to the FDA letter. It would be a good idea to read it carefully: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm403255.htm

You can see how sophisticated and efficient the FDA has become in their research. The letter illustrates that they did a careful analysis of each Twitter post, each Facebook post, how they linked, a website review, and more.

 

Some people, including myself, would say that although we may be frustrated with the inefficiency of bureaucracy, it is exactly that inefficiency that helps keep our freedoms. The FDA, in this case, is sadly becoming more efficient.

 

Regulatory bodies have surpassed any recognizable common sense in how they view the world. In this particular case its analysis cites that this natural cough syrup is

 

“offered for conditions that are not amenable (coughs) to self-diagnosis and treatment by individuals who are not medical practitioners; therefore adequate directions for use cannot be written (for coughs) so that a layperson can use these drugs safely for their intended purposes.”

 

It is sad that we have created such a politically compromised - and in some cases - a corrupt machine as the FDA (and their international counterparts).

To stay safe through these crazy times, I’ll repeat what I said in a previous post:

1. Let word-of-mouth advertising do the job. You may not grow as big or as fast, but you will still be around to serve those customers that believe in your product, your right to sell it, and their right to buy it.

2. Be scrupulously honest and do not dramatically market your product.

3. Be mindful of the politics and new regulations.

4. Support each other by sharing information and looking out for each other.

5. Help educate consumers on the issues surrounding health freedom.

Companies Beware of Positive Customer Feedback

Strange times indeed when we have to worry about the good things customers say about our products.

The use of social media is here to stay with many companies having Facebook and Twitter accounts where they post information on their products. This media allows our customers to comment and to give positive feedback about their experience with the products. In response to a customer comment, we politely and naturally respond by “liking” the comment they left for us. According to the Alliance for Natural Health (ANH), the FDA now considers “liking” a customer’s testimonial, a claim. By “liking” what your customer said, it transforms your product into a drug or medical device. I kid you not. As well, if you link to a site that makes a claim or link to a scientific article, those are still considered making claims about your products. These links or “likes” turn your product into a drug or a medical device.

This is a head’s up folks. We simply must curb the natural tendency to be enthusiastic and truthful about products that work and that help people. These are politically dangerous times when practitioners and company owners are going to jail over these issues. I know that our first response is to feel righteous, to stand on the moral and ethical high ground and snub our noses at authorities. However, in the short term, we need to educate ourselves about the regulations that do exist, whether for good or for evil, and abide by them to the greatest extent we can, even if this means it keeps your business smaller. The goal is to be around for the long term and changes will be coming. The near future is fraught with danger because there is tremendous push and pressure from multinational corporations to control everything natural, to block out any upstart innovation, and to fully control or crush any existing technology or ingestibles that may interfere with their current or future profits. Of course, it is no secret that these multinational corporations provide big campaign dollars and continuously lobby politicians. There is also a revolving door with executives of multinational corporations moving to executive positions in government to ensure that regulations supporting those multinational corporations are put in place, and then they use the revolving door to return to their corporate positions.

Let’s stick together and be supportive of each other. In so many cases where a company has had their knuckles rapped or worse by regulators, the company points the finger at another company saying, “they are doing it too.” Please let’s work together for the good of all natural health companies. Be mindful, responsible, support each other and stay safe.

Why Don't Companies State the Benefits of Their Products?

Often, I am asked why companies don’t share more information about their health-related products. People are either surprised or don’t believe that companies are not legally allowed to state potential benefits—even when the benefit may be well documented. The following two examples show just how difficult it is for companies to talk about their products.

1) A walnut packager had decided to list the heart-health benefits of eating walnuts on their packaging. The nutrients in walnuts are well known to support the heart. The packager received a letter from the US Food and Drug Administration (FDA) stating they were in violation of the law because they were selling an unapproved drug.

2) A manufacturer of a pillow with the herb lavender inside of it included the story of the traditional uses of lavender to help induce relaxation and sleep, with their product. They too were sent a letter citing it was against the law to market an unapproved medical device.

These two stories are by no means rare and illustrate how far regulators will go and how silly they can be. Only a minority of cases the FDA investigates are what we would consider true fraud. Fraudsters are individuals and bogus fly-by-night companies that set up shop, make wild claims that are exaggerated or false,  take our money and then get out of town. Contrary to what governments would have you believe, these companies are not typical. There will always be about 1% of any population of people or companies that finds a way to abuse the system and health companies are no exception. Unfortunately what happens is that ALL companies selling products become suspect and regulators view them and treat them in the same category as those who are truly unscrupulous and criminal.

In my experience, in most cases, advertising infractions are made by good people following their heart and sharing truthful information about the benefits of a product—benefits based on users’ experience, empirical evidence, new theories and real-time science. This form of evidence is unacceptable to regulators, not because it is bad evidence, but because of economic and political influences.

Take the case of one highly controversial product that has been in use around the world: The Hulda Clark Zapper. About a decade ago, there was a tremendous amount of regulatory push to remove these devices and all information surrounding the Zapper, from the marketplace. The push seemed to quiet down until recently when I was sent a copy of a letter showing the renewed efforts by UK regulators. Their letter stated:

Dear Sir Madam
I am a compliance inspector working for European Regulatory Affairs within the Medicines and Healthcare products Regulatory Agency, currently investigating the supply of Dr Clark Zappers to and for use on UK consumers and it has come to my attention that your website sells Dr Clark zappers.

The intended purpose for Dr Clark human use zappers is mainly the treatment of numerous illnesses including cancer and HIV so they are medical devices and as they depend on a source of electricity are classified as Class IIa medical devices requiring Notified Body Certification which they do not have.

As the zapper is intended to treat cancer, it is not possible for the device to be legal to sell due to the cancer act of 1939.

I would be grateful if you would therefore remove it from offer and exposure for sale on your website within 7 days and supply me with full name and contact details of where you purchased them from.

Failure to remove Dr Clark Zappers from sale will result in enforcement action including deletion of domain “deleted name.com”
 
Companies that have experienced enforcement action know what a heavy emotional toll it takes. It can involve threats, bullying,  physical action by police and in some cases even jail. Regulators don’t go after consumers buying the products, but they do limit access to products by making sure they aren’t sold in the first place. This means going after those that sell or promote the product. In the above case, the owner of the business stopped selling Zappers, as many other companies have done as well. This is despite the fact there is still a strong demand by the public for the product.

This letter also makes reference to the Cancer Act of 1939. Most countries, like the US and Canada have legislation preventing the marketing of any product that is for treatment of a Schedule A list of diseases. What is interesting in the letter above is  that the UK has a law specifically about Cancer advertising. The 1939 Act reads:

"An Act to make further provision for the treatment of cancer, to authorise the Minister of Health to lend money to the National Radium Trust, to prohibit certain advertisements relating to cancer, and for purposes connected with the matters aforesaid."

To be fair, even chemotherapy and radiation, which are the only approved treatments for cancer, cannot advertise either, but then again, they don’t have to when they have a monopoly as cancer treatments across the globe. The fact that the UK government lends money to the Radium Trust, and prohibits advertising related to cancer, certainly seems to give radium producers a sweetheart deal. It was much the same beginning in North America. Radium gained its start in cancer treatment in the US early in the 20th century, when the tycoon of radium was the principal backer of Sloan Kettering Hospital, which was to specialize in cancer treatment, specifically with the use of radium.

The truth is there is really no way to combat an entrenched system based on back room deals of the past and present day monopolies. The only power we have as consumers is to inform ourselves to make the best choices for our own health.

What we can do as companies is:

1)    Let word-of-mouth advertising do the job.
2)    Be mindful of the politics.
3)    Support each other by sharing information and having each other’s backs.
4)    Help to educate consumers on the issues surrounding health freedom.

FDA Ignores Studies of Safe, Non-Pharma Products

The story of Cranial Electrical Stimulation (CES) in North America is a tale of government intrigue. CES technology applies gentle and pleasant-feeling frequencies, using electrodes that are usually attached to the earlobes, to balance neurotransmitters in the brain. Decades ago, one pioneering company for this technology decided to get FDA approval, in order to make claims beyond pain relief. This century old technology, originally known as Electro-sleep, has hundreds of research studies behind it and has been in common use over many decades. Studies show that CES helps with depression, learning disorders, insomnia and even addictions. It has been well proven to be a safe and effective technology, which can readily be used at home. And yet, thirty years after it first entered the market in the US, CES companies continue to have an uphill battle with the FDA. 

Categorized by Risk

 As background, health or medical devices are categorized according to risk. The “risk” is based on what claims are made for the device, how it will be used, and the danger of the device itself. An example of a Class I device, the safest category, would be a tongue depressor. An example of a Class II device would be an electronic instrument such as a TENS microcurrent device. Examples of Class III devices are implanted devices and lasers for surgery on corneas.

510k Application or Pre Market Approval (PMA)

To get approval to market a device in the US, either a 510k application or a Pre-Market Approval (PMA) application is required. The 510k process is the simpler of the two application processes. All a company has to demonstrate is that the device is safe and effective and it is substantially equivalent to other devices already on the market. The PMA process is far more complicated and requires a long and expensive process of scientific and regulatory review to evaluate the safety and effectiveness of a device. For a PMA application, the FDA has determined that requirements of a 510K application, including general (good manufacturing practices) and special controls (requiring a doctor’s prescription) are not enough. The process is arduous, and the rules are stringent. A PMA must provide a greater burden of proof of the scientific merit of the device. If a device can’t meet the expectations of the FDA, then it is considered adulterated and cannot be marketed. This doesn’t indicate there is a real safety or efficacy risk - it can simply mean the FDA doesn’t like it.

The FDA and CES Devices

 Politics, not science, dictated from the beginning that CES devices be classed as a Class III device with special controls - meaning the device can only be sold with a doctor’s prescription. Since CES devices were substantially equivalent to other devices already on the market, only a 510k application was needed at that time instead of the more rigorous PMA. Despite assurances of safety from the FDA’s own review panels, the agency has maintained a bias towards the technology. For thirty years, CES companies have been continually bullied by the FDA. Harassment has ranged from delaying shipments, to mixing up paperwork, physical harassment by officials and generally causing both a costly and emotional experience for the companies involved.

Despite the harassment, the companies have persisted to try and get CES reclassified to a Class II device, which would allow it to be sold directly to the consumer, without a doctor’s prescription. All of the safety and scientific data supports a Class II designation. China and European governments have given Class II status to CES devices. This means these governments, after reviewing the same documentation as the FDA, consider the technology so safe it can be sold directly to the consumer. Over the years, however, the FDA has continually rejected reclassification – that is until recently.

From 2009 to 2013, the FDA required all manufacturers of CES devices to resubmit all known research and safety data. The FDA indicated it would review the resulting 275 pages of research and clinical data to finally determine if CES should be reclassified to Class II, or even to Class I. In 2011, the FDA published a new (and shocking) rule that all CES devices, including those already on the market, had to go through the PMA application process. Despite the 30 years of evidence of safety and efficacy, the more strict and expensive PMA process would be necessary. The manufacturer of one CES device has pointed out how unusual this is, as the purpose of the PMA process was to determine safety and efficacy of only new devices. “It is strange, to say the least,” he said, “to put a device through that process when it has already been legally marketed for 30 years.”

In essence, the FDA reset the clock and rewrote history. Manufacturers have to start all over again at a cost of many more millions. A safe and effective non-pharmaceutical therapy is now classified in the same group as implantable devices such as pacemakers, spinal cord stimulators and replacement heart valves.

The FDA justified the need for a PMA application based on some of the following reasons: The FDA cites the theoretical possibility that someone might have a seizure, even though in a hundred years this has never been reported in any study. The FDA has also said there was potential for blurred vision because of placement of electrodes over eyes. This is irrelevant, as no manufacturer in North America has ever had a protocol to place the electrodes over the eyes. It was a practice in Russia that was stopped several decades ago. The FDA further pointed out the theoretical possibility of adverse events from electrically stimulating the brain. Again, in all the studies, over all the years, this has never been an issue.

Basically, the FDA has created potential side effects to make CES appear unsafe while at the same time  ignoring all CES research including those studies that meet their own definition of "scientifically valid." In contrast, the FDA applies a different rule to drugs that are given a “black label warning” despite the fact that very real dangerous side effects occur and which have maimed and killed people. In the end, the FDA panel concluded that the excellent and proven benefits of CES did not outweigh the non-existent risks.

What does this mean for consumers? It means most consumers won’t discover this safe and effective technology as an alternative to drugs because it has to be prescribed by a doctor. Doctors are not trained in non-pharmaceutical technologies, so most physicians don’t even know it exists. It also means much higher prices to consumers as companies must recoup the costs of continually going through expensive, unnecessary, and burdensome bureaucracy. It means some good companies are forced underground. It means new, innovative products are either bullied from the marketplace or don’t even get to the market because of the costs and harassment involved.

To read one company's interactions with the FDA, please read:
http://www.alpha-stim.com/wp-content/uploads/FDA-History-Alpha-Stim-CES-FINAL.pdf

In Summary

Once again the FDA’s actions speak to their bias against low cost, non-pharmaceutical and natural treatments, and the lengths they are able to manipulate the process to treat one group of therapies different than their pharmaceutical counterparts.

Will the New FDA Act Stimulate Innovation?

On the surface, the new “FDA Safety and Innovation Act,” which was recently passed by President Obama, sounds exciting and progressive. We can probably all agree that innovation is healthy. However, we shouldn’t be fooled by the title, as this new law isn’t as progressive as it might sound. 
 
To be fair, there are aspects of this new Act that could work: Faster access to new pharmaceutical therapies for patients with rare diseases, promoting views of the patients and soliciting the views of representatives who have minimal financial interests in the products, are some of the promising highlights. Only time will tell if they live up to the promises. 

One of the more troublesome aspects of the Act is the new cost-recovery provisions for the FDA. In contrast to the intention, this provision will stifle innovation and consumer access to new products.  

A Brief History Lesson on the Cost Recovery Methods of the FDA 

In the recent past, the FDA introduced a fast-tracking method for new products - mostly pharmaceutical. Manufacturers could pay the FDA a million dollar fee to expedite their application. Obviously, these fees can only be paid by wealthy multi-national companies - namely big Pharma. Smaller companies simply do not have the same capital available to them to fast track their applications. 

The New Cost Recovery Methods Proposed by the New Law 

Obama’s new Act further expands the FDA’s cost recovery ability. The most obvious change will be an increase in fees and the introduction of new fees for companies who are trying to bring a new product to market. The FDA does have reduced rates for what it calls ‘small’ companies – those with gross receipts or sales below 100 million dollars. In this instance, the fee would be $62,000. For those with less than 30 million in gross receipts or sales the first-time application fee is waived. The application fee is just the first fee. In addition to the application fee, there are many other fees involved with submitting a product for FDA approval. None of these fees are waived. The FDA’s process and this new Act virtually make it impossible for a small business to navigate the FDA application process. While the FDA’s definition of ‘small’ companies are those with 100 million dollars or less in sales – a true small company may do one million dollars or less in sales.  

Does the Act help small business bring their products to market? 

Giving a first-time application fee exemption to a small company does nothing to help the company, as it is highly unlikely any product would pass upon the first application. Secondly, most of us would disagree on the FDA’s definition of a small business as a 100 million dollars in sales. Many small device manufacturers would be happy to do a million dollars in sales never mind a hundred million. I’ve worked with many, very good and honorable small companies and none of them could afford the FDA’s ongoing fee schedule. This gives further proof to the existing and growing bias against new technologies developed by small non-pharma businesses that are in the health field. Even if a company was able to meet the ongoing regulatory fees, there is a whole realm of other challenges put in place by the FDA outside this one Act. 

Does the Act help consumers have better access? 

The Act may help consumers have better access to drugs manufactured by big Pharma. It does not give consumers better access to new technologies developed by small businesses. In fact the Act suppresses consumers’ access by making the process to costly for small businesses to gain approval. Even if the company manages to meet the financial burden of going through the regulatory process, they will need to recoup the costs of approval. In most cases, this means the products are too expensive for many consumers which again limits consumer’s access to new products.  

Does the Act promote innovation? 

The fee structure outlined in the Act makes it clear how tragically impossible "innovation" will be. A company that may have an innovative product will also need the type of research funding that is usually only found through universities. Universities tend to accept only research projects that are mainstream and the “right” kind of research. Small companies cannot afford all the costs involved. This is tragic for society, because so many simple technologies out there are already inherently safe and affordable and cannot be brought to market due to the biases of the FDA and other professional bodies. 

In Summary 

While the new Safety and Innovation Act claims greater access to innovation, in practice it excludes innovation from any source except for those who have the money. These are the very entities that manipulate the regulations, regulators, and the market to eliminate competition. This Act ensures the system will continue to be about money and power - not innovation, access, or greater health. The status quo continues.