Saturday, October 1, 2016

Vitamin Consultancy September 2016 Newsletter

Mail Chimp Version
CDC dangerous quarantine and treat/vax regulation
FDA offers 102 page NDI guidance
From: Ralph Fucetola JD

Welcome to the September 2016

Vitamin Consultancy eNewsletter.

The banner above, featuring yours truly and my co-trustees at Natural Solutions Foundation, Rima Laibow MD and Maj Gen Bert Stubblebine (US Army, Ret.) points to a very important and urgent matter.

The CDC has proposed a draconian quarantine and forced treatment/vaccination regulation, giving the public until October 19th to file comments. Under the Administrative Procedures Act, this is a necessary step for agency action, or for litigation testing the validity of the new rules. What does the rule say about Informed Consent? It says your consent "shall not be considered as a prerequisite..."

“§70.18 – Agreements. CDC may enter into an agreement with an individual, upon such terms as the CDC considers to be reasonably necessary, indicating that the individual consents to any of the public health measures authorized under this part, including quarantine, isolation, conditional release, medical examination, hospitalization, vaccination, and treatment; provided that the individual’s consent shall not be considered as a prerequisite to the exercise of any authority under this part.”

The FDA's guidelines for what is a New Dietary Ingredient (NDI) were issued in 2011. Last month an updating was proposed as FDA continues to implement a policy of making Dietary Supplement rules more like Pharmaceutical Rules rather than the food-standard regulation that Congress determined to be public policy in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The new document is 102 pages. The Devil, as they say, is in the Details. As is the deviltry...

This note is just to acquaint you with the fact that the rules are being made tougher. Bottom line: [1] what is an NDI and [2] how much harder will it be to have one approved by FDA?

[1] The definition, set by statute has not changed. The FDA now phrases it this way:

"On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub.L. 103-417) was signed into law. DSHEA amended the FD&C Act by adding, among other provisions, (1) section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement”; and (2) section 413 (21 U.S.C. 350b), which defines the term “new dietary ingredient” and requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)(1))."

[2] How much harder? That of course translates into, how expensive?

The more restrictions, the more expense. Being "grandfathered" and thus exempt from the NDI process is not easy, for example:

"A notification is not required when the NDI and all other dietary ingredients in the dietary supplement have been present in the food supply as articles used for food in a form in which the food has not been chemically altered. ... FDA interprets the phrase “present in the food supply” to refer to the conventional food supply. Accordingly, we interpret a dietary ingredient that has been “present in the food supply as an article used for food” to mean a conventional food or conventional food ingredient. We do not consider prior use in dietary supplements to constitute presence in the food supply."

More directly impacting cost is what are the requirements to prove the safety of the NDI?

"That standard provides that a dietary supplement containing the NDI is adulterated unless there is adequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury."

What evidence is sufficient to meet this standard?

"A notification should provide evidence of a history of safe use; other evidence of safety, including clinical testing, animal testing, or both; or some combination of history of use and other evidence of safety. The submitted data should provide the basis for a conclusion that there is a reasonable expectation of safety under the proposed conditions of use of the dietary supplement containing the NDI."

And, to the wise this interesting hint:
"FDA expects that when history of use evidence alone is adequate to support the safety of the NDI in the supplement, notifiers will prefer to use that route. Compared to the cost and time needed to conduct clinical or animal toxicology studies, it is generally less expensive and faster to gather historical information and to conduct chemistry studies to establish the identity of the historically used materials."

So, as your vitamin business moves ahead, you will need guidance in dealing with New Dietary Ingredients.

The Vitamin Consultancy is here to help with all aspects of new product development, from concept through testing, labeling, claim writing and the rest of your product presentation needs.
Standard Operating Procedures
Dietary Supplement and Natural Products
Development, Training & Deployment


...documentation of employee training is necessary

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