Saturday, December 21, 2013

Hope for Liberty: Three Opinion Polls Indicate Major Public Opinion Changes

Health and Food Freedom to Lead the Way?
The Tenth Global Health Freedom Anniversary!

Over the past several months three polls, two conducted by Gallop, Inc. [] suggest, IMHO, that a real "sea change" is occurring among American voters. These polls cover (1) Trust in Government, (2) Support for the "Two Party System" and (3) Freedom Threat Identification. We are seeing a powerful rejection of the status quo.

The polls, which have been conducted repeatedly, for decades, show a powerful change starting in late '06 and accelerating into the astounding results of the latest polls. Trust in government is gone. Support for the so-called "two" [tax-eater] party system has evaporated. Big government is seen by practically everyone as the biggest threat to our futures.

Here is the Poll summary images, posted here for comment.




 A number of possible conclusions may be drawn from these astounding trends. Clearly there is a megaquake waiting in the political landscape. What we used to fear were only minority trends in favor of Liberty are becoming nearly universal opinions.

My concern here is how that extraordinary change in political consciousness will impact health and food freedom. With under 20% of the population "trusting" government, will people continue to support Big Govt coercive interventions such as mandated vaccines? Or mandated health insurance? Will people demand that crony govt finally get out of the way of heritage, non-GMO and organic farmers, co-ops and marketers?

This coming year is the Tenth Anniversary of the founding of Natural Solutions Foundation by Dr. Rima E. Laibow, MD and Maj. Gen. Bert Stubblebine (US Army, ret.) in 2004. It has been my privilege to work with them and the Foundation since shortly after its founding. The past decade has been amazing!

Nearly a hundred Accomplishments are chronicled here:

Buoyed by a powerful tide rejecting Big Govt and its crony anti-health corporatist allies, we expect to see the sacred cows of illness and hunger control, the FDA, the EPA, the USDA, Codex, WHO and FAO, among others, come under increasing public scrutiny by a population battered with the Five Big Lies...


The time has come to take back control over our own health and food, and that of our families. The first step: make sure you are on the Health Freedom eList. Go here to join the list:

Then make sure is "white listed" by your email provider. You will not receive the vital information we make available every week without volunteering for the eList!

The second decade of health and food freedom begins!

Monday, November 25, 2013

Ingesting: DSHEA-Required Dietary Supplement Delivery System

DSHEA-Required Dietary Supplement Delivery System: Ingesting

The Dietary Supplement Health and Education Act of 1994 (DSHEA) states, that a Dietary Supplement protected by the law is, in part, "...a product that - "§3(2)(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i) [21 USC § 350(c)(1)(B)(i)]. Section § 350(c) further clarifies, "...intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet."

I recently exchanged emails with one of my clients that offers sophisticated liquid dietary supplements. The company was concerned that its product directions might be risky, considering some recent FDA warning letters, relayed to them by an attorned well-versed in FDA regulation [my comments about the cited warnings in [brackets] below].

The company's product directions was, "Dissolve in mouth and swallow."

My response:

It would not surprise me that the FDA is continuing to tighten the rules, as the agency seeks to make Dietary Supplement regulation more like Drug Product regulation.  
However, the examples given by counsel are all dependent on the delivery being "topical" or "sublingual."   I don't see how "dissolve in mouth and swallow" is a "sublingual" delivery intended to "treat"-- unless there is some language in the product literature that leads to that conclusion. 
However I must further caution that FDA likes to create "per se" rules, although the law requires a showing of "intent." The FDA language below, that products "intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements." is the key to their thinking. 
What do I mean by that? As the statutory and warning language information above shows, that "intent" is a key element in the definitions. That's because foods are generally recognized as safe when used as directed. The use direction must match the intent of the marketer. The more clearly we can state the directions to the users, the safer the public will be. 
I suggest language such as, "Ingest product by dissolving in mouth and swallowing."


Ralph Fucetola JD

------ Original Message ------
Received: 11/19/2013
From: E.
To: Ralph Fucetola
Subject: Delivery of supplements

Dear Ralph,

    Last week at the natural products expo in Las Vegas I met a regulatory attorney, Chris Celeste, who voiced some concerns about the permissibility of delivering a dietary supplement in the mouth and then swallowing.  He has provided some references to FDA Warning Letters (below) I'd like for you to look at to see if they apply to us. 



    Begin forwarded message:

>     From: Chris Celeste, Esq.
>     Subject: sublingual tables
>     Date: November 19, 2013 6:16:10 AM PST
>     To: E.
>     Dear E,

In follow-up to our discussion at the SupplySide West conference I wanted to provide you with the information we had discussed regarding sublingual tables. Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the Food Drug and Cosmetic Act to establish standards for dietary supplements. Under Section 201,(ff)(2)(A)(i) a dietary supplement must be for ingestion in a tablet, capsule, powder, softgel, gelcap, or liquid form... that "is intended for ingestion..."

FDA has issued several Warning Letters to firms regarding the use of “sublingual” tablets. I have provided links to these letters for your reference:

Griffon Marketing [Topical product; not ingested.]

“Tranzabol is topically applied for transdermal absorption to achieve its intended effect. Cyclobol Sublingual Tablets is a sublingual product. These products cannot be dietary supplements because they are not intended for ingestion since they are topical or sublingual products that are intended to bypass the alimentary canal by direct absorption through the skin, or oral mucosa. The Federal Food, Drug and Cosmetic Act (the Act) defines the term, “dietary supplement” in Section 201,(ff)(2)(A)(i) to mean product that is “...intended for ingestion...” Consequently, a product that is not intended for ingestion cannot meet the definition of “dietary supplement”. “

Pinson’s Fitness Products [Topical product or intranasal; not ingested.]

“Test-4-Blast, Deca Derm and Dermadrol are topically applied for transdermal absorption to achieve their intended effect. Primavar SCC Sublingual Tablets and Pharmalogic XRX Inn-a-Oral (nasal) Androgenix Spray are sublingual or intranasal products. These products cannot be dietary supplements because they are not intended for ingestion since they are topical, sublingual or intra-nasal products that are intended to bypass the alimentary canal by direct absorption through the skin, oral or nasal mucosa. The Act defines the term, "dietary supplement" in Section 201 (ff)(2)(A)(i) to mean a product that is ". . . intended for ingestion.. .". Consequently, a product that is not intended for ingestion cannot meet the definition of "dietary supplement".”

Supplement Giant [This is the key language: "intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements...."]

“In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.”

Golden Creek LLC [Same as above.]

“In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.”

Chris Celeste

Sunday, November 17, 2013

Regulatory Compliance and Return on Investment

Vitamin Lawyer Health Freedom Blog
I Spoke in NYC on November 13, 2013

Memorandum from Ralph Fucetola JD

November 17, 2013

To: Potential Natural Product Company Investors

This Memorandum is to acquaint you with the benefits to your Company raising sufficient capital to comply fully with FDA/FTC SOP/ GMP & Clinical Study Guidelines.

Good Studies lead to good claims.
Good claims lead to increased ROI!
Properly Structured Standard Operating Procedures and
Trained Employees lead to significant regulatory savings.

Getting Ready for the FDA & FTC --

Even more evidence that the agencies are serious about nutrient & natural product claims; this from the Natural Products Association in March 2011:
“A new and completely different type of safety website is now open for business. Almost anyone can post information about a consumer product they believe might be dangerous or has already caused a safety problem. Not only will this database of consumer comments be public, it also will be searchable. "Through this database consumers will have open access to product safety information that they’ve never seen before, and this information will empower them to make safer choices," said Inez Tenenbaum, chairman of the U.S. Consumer Product Safety Commission.”
What does that mean? It means your Company reputation can be ruined by willful false posters; it means the govt will be trolling the site to find companies to harass…

And consider these “data points” from the last two editions of my Vitamin Lawyer Update eMemo: the UK advertising agency, the ASA now states, according to, “research on the ingredients was not the same as research on the product itself…”

Let’s repeat the key phrase: “…research on the ingredients was not the same as research on the product itself…” – and “research on the product itself” means a Clinical Trial, of course! The substantiation generated by the Clinical Trial is the legal basis for making product claims.

The Natural Products Association (NPA) said in February ‘11 – “Time's Up: FDA has begun real enforcement of dietary supplement GMPs. Companies of all sizes are being inspected.  Are you ready?

Is your Company ready? What does it take to be ready? See Below.
The above Red Letter warnings from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  Below are the 4 essential steps you must take with estimates of the investments these essential steps require from your Company. You need to budget this investment now and start to do what you can to be prepared; in this way you will outperform the competition who will not be so prepared.

HHS Secretary Sibelius admitted a couple years ago that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats! SOP Certification Training is what your company needs.

Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training,  the type of training, and the person(s) trained."
Federal Register, page 34811

What do you need to survive an FDA inspection? Go here: 

1.       Standard Operating Procedures – in place and up-to-date. GMP compliant detailed SOP documentation not only satisfies FDA & FTC, but also helps you organize your business!

2.       Product Substantiation Notebook – in place and up-to-date; this Notebook is a MUST if you get inspected! The Notebook should includs copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim.

3.       Your ROI can be strongly enhanced by copy-writers who know how to avoid Red Flag claims & Illegal Testimonials!

4.       A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients.
The Dietary Supplement and Natural Remedies market is at a unique moment in its recent history.

The market has grown from under a billion dollars when the Dietary Supplement Health and Education Act (DSHEA) passed in 1994 (the first law allowing claims to be made for such products) to about $50 billion in 2009. The current recession is only having a marginal effect on the nutrient market and one survey shows that 51% of the purchasers would cut back on food purchases rather than vitamin purchases. At the same time, significant regulatory initiatives have occurred during the past years with potential impact on the market. After 14 years, FDA finally issued Good Manufacturing Practice (GMP) regulations for the industry during June, 2007 which became completely effective in June 2009.

All of these factors contribute to a growing industry that typically sees, after initial investment, a cost of goods, for start-ups, at about 20 to 25% of retail, rapidly moving down to 10% as new companies are able to order product runs in the hundreds of thousands of capsules.

Bottom line: savvy investors, seeking reasonably assured ROI, will find in the natural products market potential opportunity, if the Company invests in in Regulatory Compliance!

Tuesday, October 22, 2013

Vitamin Lawyer Appears with Gov. Gary Johnson

Video Highlights from the OAI Event:

November 14, 2013 Update: Drew and I were with Gary Johnson last night in Manhattan for a panel discussion of health and freedom. We have some excellent video footage which we will post here and on YouTube.

I asked the former (G)OP governor what he thought about libertarians and TEA Party people working with the (G)OP. He laughed and suggested the party leadership really doesn't want us. He sees real potential for all patriots cooperating, provided we stick to economic freedom issues. He noted that it's social issues that have divided the patriot movement but economic issues (including the Unaffordable Care Act) can unite us, especially when, as with Obamacare, both freedom and our pockets are at stake.
I spoke in NYC on November 13, 2013 at an event sponsored by OAI.

This note from OAI's Charles Frohman
"Most voters are fiscally conservative like the Republicans, yet socially liberal like the Democrats.  Neither party is a clean fit for most, though.  The same goes for grassroots movements - they're tied usually to one or the other party.  Governor Gary Johnson's movement, the Our America Initiative, DOES try to address the preference of most voters by exploiting the IRS' audit scandal with an effort to abolish the income tax on the one hand, and on the other hand by speaking Saturday, October 26th at the StopWatchingUs protest to save 4th amendment privacy from the NSA's warrantless spying. The governor is headlining events in Washington, D.C. the weekend of October 24th and then in New York the week of November 10th." 
Meet Governor Gary Johnson in New York:

Wednesday, Nov 13th - 6 pm Happy Hour at the Players Club, 16 Gramercy Park, "What Now With Health Reform?" with special guests Dr. Eck, past president of the free market doctors group AAPS, Ralph Fucetola the Vitamin Lawyer and FDA expert, and Lee Silver, Princeton genetics professor and author of Remaking Eden.

I look forward to seeing you there!

Sunday, October 20, 2013

Natural Solutions Honored for
Powerful Social Media Campaign

I am so very proud of the extraordinary work of Natural Solutions - Chile. They have been honored by Salsa Labs (Democracy in Action) for one of the most successful Social Media Campaigns of 2013.


My co-trustees at Natural Solutions Foundation -- -- Dr. Rima Laibow and Gen. Bert Stubblebine have been living in Chile for the past year, developing Foundation projects that need the "lower radiation" Deep South for their success (see: ).

And that's when the cronies at Monsanto, Cargil, et al. made their mistake: they thought grabbing control over agriculture in Chile would be a simple task, as it has been in so many other countries. The National Assembly passed the proffered bill, to move Chile from the relatively organic/heritage agriculture friendly UPOV '78 (UPOV is the international seed regulation) to UPOV '91, decidedly unfriendly to the agriculture that my co-trustees went to Chile to promote, so those of us here in the ever more radioactive North can get more lower rad organic produce from the Deep South.

We are working with some of the world's major Truth Speakers regarding the continuing disaster at Fukushima (people like former Japanese Ambassador Murata, "The Conscience of Fukushims" and Professor Chris Busby, a leading EU radiation watchdog).

That hasn't stopped us from focusing on generating good, wholesome food from the Deep South to the North, so, as you can imagine, we were not happy to see Chile about to join the ranks of the GMO-infected nations. So what did Dr Rima and Gen Bert do?

They enlisted the help of our magnificent staff in Chile, Natalia and Naty, and did something that had not been done before: used the Social Media to change the course of the Chilean Government!
This year’s winner is the Natural Solutions Foundation for their Chile: Stop UPOV ’91 efforts. They used Salsa to generate more than two million emails to decision makers in Chile, stopping the passage of the new guidelines and protecting the rights of South American farmers. The other finalists for the Hell No, We Won’t Go Award were the Organic Consumers Association and New Era Colorado. (
 Dr. Rima, Gen. Bert and 'the two Natalias' deserve congratulations! The Social Media power unleashed by them stopped the cronies and the Senate of Chile has refused to pass the new law. Two and a half million emails through our Educate Decision Makers System has profoundly changed the farming landscape!

And that's not all... GMOs and organic/heritage farming has become a major issue in this year's elections in Chile! PUSH BACK WORKS.

Tuesday, August 20, 2013

FDA Illegally Claiming
Dietary Supplement Reinspection Fees

FDA Warning Letters to Vitamin Companies
Now Demand Reinspection Fees.

We fought hard to exempt Dietary Supplements from the unnecessary, misnamed 2011 "food safety" (really Federal Food Monopolization) law*. Others told us not to bother since Dietary Supplements were not even named in the law. We knew better and one Push Back weekend of 150,000 emails to the members of a certain Congressional Committee kept the Dietary Supplement Exemption in the bill; further Push Back effort kept the exemption in during the House/Senate Conference and the provision was enacted, reading:
21 U.S.C. 305(d) Rule of Construction.--Nothing in this section shall be construed to affect the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417).

This remains the law, although FDA showed, with its unlawful banning of a certain form of Vitamin B-6 a year later that it was willing to ignore the explicit order of Congress.

Another part of the 2011 law let FDA charge unspecified fees for reinspecting food facilities. Starting last December and continuing as recently as last month, FDA began including the following language in its warning letters to Dietary Supplement label-owners:
"Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act..."
(Emphasis added.)

The Congressional intent was clear, although obscured when the Exemption Section was oddly codified in section 305 which is about inspecting foreign food facilities. The intend was to exempt Dietary Supplements from the new, very strict, "food safety" rules.

FDA has a history of ignoring Congress and legal restrictions, prompting many Court decisions against FDA assertions of power. It was former Congressman Ron Paul who opined that giving more power to FDA was giving it "more power to abuse..."

The agency is at it again, this time seeking to impose a bureaucratic "tax" on companies when they are reinspected. Since the Obama Administration has rapidly increased the number of inspections and reinspections we can expect this new fee to become a significant burden on small and start-up companies. More crony corporatist monopolization.

In my humble opinion, the FDA is barred by law from imposing reinspection fees against DSHEA regulated Dietary Supplements.

The question is, will the industry assert its rights under the law or just allow yet another usurpation by this most overreaching of the Federal "alphabet agencies?"

One thing each Dietary Supplement label-owner MUST do is to make sure "your papers are in order..." so there is no excuse for a reinspection.

See my site at:


Thursday, July 25, 2013

FDA Targeting Vitamin Companies

The Regulatory Compliance Network Responds 

FDA News, an industry information source, put it succinctly a couple weeks ago:

"FDA on the hunt..."
Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus...”
When health freedom advocates convinced Congress to unanimously adopt the Dietary Supplement Health and Education Act of 1994 (DSHEA) it was no easy task. I remember those days, before the internet, well. We rallied at FDA locations around the country; we lobbied Congress the old-fashioned way, with phone calls, letters, petitions and faxes. I remember bringing my then 5 year-old son to DC for the march on the Capitol that lead to adopting DSHEA, the law that allowed us, for the first time, speak truthfully about the nutrient benefits of dietary supplements. It was a breakthrough and the bureaucracy has been trying to take back those concessions to our freedom of inquiry and speech ever since! We didn’t give up in ’94 and we will not let the stimulus-money, beefed-up FDA regulate our industry out of existence. The Regulatory Compliance Network, a collaboration of industry professionals, is ready to react proactively:

We knew at the time, in ’94, that the bill was a compromise between our right to seek natural means for health and the power of the Big Pharma lobby, aided and abetted by their cronies in the federal agencies. But Congress not only acknowledged our right to communicate about, and market dietary supplements, it also told the FDA that any regulations about good manufacturing procedures must be modeled after food regulations, not drug regulations. That difference is significant. Dietary supplements are foods, not drugs. Foods support normal structure and function. Drugs change the body to suppress symptoms of disease.

Fast-forward about a decade. FDA finally got around to implementing the regulatory authority granted by the dietary supplement law. Two primary sets of regulations, with associated guidelines, were proposed, adopted and phased in, over the several years. These were the “Structure and Function” regulation that tells companies what types of “support” claims can be made for dietary ingredients and the cGMPs – the Current Good Manufacturing Practices regulation. Today, with those regulations in place, and with thousands of new compliance offices hired with Federal stimulus funds, the FDA is, as our industry source says, “On the hunt…”

The Natural Products Association opined,
"FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “'the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.'..."
One FDA Compliance Officer told me:
Your company, as label-owner, must be in a state of control with its training, labels, claims, manufacturer, shipping & customer service…”
In the past I would tell my dietary supplement clients that they might be inspected by the FDA once in a decade, or not at all. Today, every company that owns its own labeled products can expect yearly or almost yearly inspections. The supplement industry is being held to strict standards and those companies that are well-organized businesses will have a competitive advantage.

To make the best of that advantage, or even to effectively communicate to the customers, “your papers must be in order…” Gone are the days when “mom and pop” vitamin companies could bottle their own products and just start marketing. Today, companies need to have a sophisticated approach to doing business. 

Standard Operating Procedures are intended to ensure that the public is offered products that are consistent as to “purity, identity, composition and strength…

But it is not enough to have written procedures, according to FDA (Federal Register, pages 34811):
"...each person engaged in an activity covered by these cGMP regulations must have the education, training, or experience to perform the person's assigned functions. Some employees will be considered qualified based in part on training taken as company employees. To show that such training is appropriate to the employee's functions and has in fact occurred, the training must be properly documented. 
This documentation is an important aspect of ensuring adequate training and, therefore, helping to ensure the result of having qualified employees who perform their functions properly.

The FDA introduced the cGMPs by reminding us all:
"The dietary supplement market has changed significantly since the passage of DSHEA. The industry itself has grown exponentially and so has the number of Americans buying these products. Access to dietary supplements has also changed. Today a wide range of dietary supplements can be purchased in supermarkets or through the Internet...”

Conducting the Certification Training at
Global Healing Center, Houston, Texas

The Federal authorities understand that Americans want their supplements. 

The strong public support that caused Congress to do that which it hardly ever does, adopt a controversial law unanimously, with no dissent, proves that. Nonetheless, the natural tendency of bureaucracy is to expand into every nook and cranny of voluntary human action. The unregulated is seen as a threat. Marketers, on the other hand, see the unregulated as an opportunity to meet consumer demands expeditiously. The tension between American industry and bureaucracy has grown for generations.

The regulatory pendulum swings this way and that way. Today, with a Federal bureaucracy emboldened by gridlock in Congress, and with ever more taxpayer or borrowed money to spend for enforcing regulations, those regulations are being interpreted in the most onerous manner, leaving little room for small companies to continue their critically important roles as innovators.

What is to be done? An aware public needs to keep the pressure on the Congress so the bureaucracy is not able to ratchet-up controls without limit. As one of the trustees of Natural Solutions Foundation – Health Freedom – I am very aware of the strong support that our dietary supplement market has from the public. You can help educate decision-makers here:

Dietary supplement company management will do what management must always do: manage. That means complying with the cGMPs to assure the public that Americans can still buy the best, highest quality and potency nutrients available anywhere on earth. To do that, the companies need to get much more serious about how they organize the ways and means they have to satisfy the consumer. My experience is that very few dietary supplement companies are in full compliance with all requirements.

The Natural Products Association sees the same issue:
"Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study … by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers.  A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.'..."
The science behind the benefits of dietary nutrients continues to advance. 

The problem the market faces is how to substantiate the claims that can be made about those nutrients. WHO, the World Health Organization, told us in 2002 that the chronic diseases of modern life – cancer, heart disease, diabetes, obesity, are all the “noncommunicable diseases of mal- and under-nutrition.” It is the role of the dietary supplement companies, whether large or small, new or well-established, to educate the public about the tremendous health benefits of good nutrition.

To do that, the companies need to stay in business by effectively meeting the increasing regulatory standards.

Education is the key. 

The companies are now required to adopt written Standard Operating Procedures and engage in third-party training and certification, to meet the higher standards expected from companies that are providing essential nutrition for our health and well-being.

That’s why I’m working with some of the leading educators in the natural products field, to form the Regulatory Compliance Network. Learn more here:

Dr. Group about the SOP / cGMP Certification Training Program

Tuesday, May 14, 2013

Medical Foods Under the Orphan Drug Act

Physicians’ Use of Dietary Supplements and Nutrients as Therapy that May Benefit 

Update:  Certification Course for HCP Now Available
Medical Foods Webinar Now Available

 Medical Foods do not treat disease; rather, they support optimal clinical outcomes by nourishing normal structure and function. A “Medical Food” under the 2005 Orphan Drug Act is any food or dietary supplement that is recommended by a physician for the dietary management of a medical condition. When recommended by a physician, the nutrient can be considered as Medical Food protected under the Act.

Here is how the Orphan Drug Act defines a Medical Food:
"…a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation....”  Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) 
The FDA, in commenting on the Congressional enactment, tells us, 
"Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods 
          a. be intended to meet distinctive nutritional requirements of a disease or condition, 
           b. used under medical supervision and
          c. intended for the specific dietary management of a disease or condition."
The FDA FAQs further inform us, 
"The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality."

And the Agency concludes: 
"In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: 
          a. the product must be a food for oral or tube feeding; 
          b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and 
          c. the product must be intended to be used under medical supervision..."
We therefore conclude from this exposition by the FDA several points of note: 
(1) the Orphan Drug Act pre-empts state regulation of Medical Foods*; 
(2) products protected under DSHEA can be considered Medical Foods, and 
(3) it is appropriate for health care providers to recommend dietary management of various nutritional and metabolic syndromes that are being identified by advanced health care practitioners.
* Many physicians are concerned about how they can integrate dietary supplements into their medical practices, since various state medical boards still have some restrictions on the inclusion of nutrition in the standard practice of medicine. Congress intended the Orphan Drug Act as remedial legislation, to address the question of the use of foods in medical practice. The Act in general is intended to exempt certain remedies from previous legal restrictions, including Medical Foods. Congress has legally pre-empted state medical regulations with regard to the “dietary management” of medical conditions. This permits physicians to recommend dietary supplements in ways that, before the Act, might have been restricted by state regulations.

Many of the fatalities or other harms people experience during standard medical treatment are not from the disease itself, but from the toll the surrounding circumstances takes on the immune system, causing malnourishment and further sickness. 

This is where nutrients step in to fight side-by-side with the patient and physician, by promoting overall wellness, enhancing immunity and supporting metabolism.  Simply put, healthier, stronger patients do better when fighting their disease compared to patients whose health has been physically compromised by, for example, cancer and the treatment for cancer. 

The type of medical conditions for which dietary management is indicated include many conditions and syndromes, including Wasting Syndrome, associated with serious diseases such as cancer or various immune system disorders.

The standard applied to the use of Medical Food is not the same standard as applies to the use of drugs and invasive modalities, such as radiation and surgery. The standard for those medical treatments is “significant scientific agreement” as mediated by FDA approval of such standard treatments.

Congress, in determining to create the separate regulatory category of Medical Food, instructed that a different standard apply. That standard is:
     “distinctive nutritional requirements, based on recognized scientific principles… established by medical evaluation…”
Thus, recognized scientific principles, as developed by nutritional science, provide the reliable and competent substantiation for the use of high-potency nutrition as Medical Food for the dietary management of medical conditions associated with disease.

As a society and medical community we are not currently at the point where we have a guaranteed "cure" to cancer or other "noncommunicable diseases of under nutrition" (as identified by WHO in 2002)… however there is always hope. Year after year, millions of patients do survive cancer and other debilitating disease.  By providing nutritional, wellness, and metabolic support, Medical Foods help patients as a complement to their prescribed medical treatment. As the physician's therapy partner and ally, the Medical Food providers will stand with physicians and patients, side-by-side. 

The Medical Foods are labeled as is usual for a food or dietary supplement, with an added label providing the requirements to meet the Medical Foods standards: a place for the physician’s name; the patient’s name; the statement, 
            “For the Dietary Management of ___________.” and “To be used under medical supervision.”
The Practice of Medicine is both an art and a science. Modern medicine has at its disposal an entire arsenal of treatment and therapy modalities. Licensed physicians are authorized by both state and federal law to bring that arsenal to bear upon proper diagnosis. State medical boards help define the standard of care. The federal FDA helps determine what drugs and devices may be used for what treatments. 

Congress, in the Orphan Drug Act, placed special emphasis on the use of nutrients, including dietary supplements, for the dietary management of medical conditions. This management is, itself, not a “treatment of disease” but is, rather, a “therapy that may benefit” permitted under AMA Ethics Code Opinion 3.04. 

In the case of Medical Foods this distinction is critical. Medical Foods, as therapy that may benefit, can be recommended by a physician and offered under medical supervision, to manage medical conditions associated with various disease conditiosn, to assure optimal clinical outcomes.

The Vitamin Lawyer Consultancy offers the Medical Community incisive CME training, “Medical Foods and Dietary Supplements In Medical Practice.My webinar course provides an overview of Medical Foods in Medical Practice. Access is available upon request: (with Medical Foods" in the subject line).

© 2013
Ralph Fucetola JD
The Vitamin Consultancy