ANTI-VAX & PROUD!
Here is a new video podcast featuring Dr. Rima and the Vitamin Lawyer.
. . .Your Right to choose healthcare with the advice of your own healthcare providers, as stated in the 07/09/2000 Wilton Declaration: "The time has come for healers and those they seek to help to... assert our Right to Heal and Be Healed... we declare our independence from bureaucratic restrictions on our fundamental human rights ... to defend these basic human rights and the healers, physicians and other practitioners alike, who we freely choose to help us achieve and maintain health. . ."
Let's allow that they do—and that a majority of scientists agree about man-made climate change and a host of other issues. Just when does the Tribunal of the Holy Office of the Inquisition meet to decide what is still subject to debate, and what is now holy writ? And is an effort to "undermine the public’s understanding of scientific consensus" always criminally negligent? Can it ever be simple scientific inquiry? Or even heroic? The history of PC Medicine, the official govt licensed and approved method for talking about and doing something about disease, is repeatedly pocked with examples of how very wrong govt medicine has been over the centuries.
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 ------
To: Ralph Fucetola
Subject: Delivery of supplements
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.”
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 -- www.VitaminIndustryCompliance.com
Even more evidence that the agencies are serious about nutrient & natural product claims; this from the Natural Products Association in March 2011:
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 WINSH.org, “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!
"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:
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. (SalsaLabs.com)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!
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).
"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.) http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339936.htm