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."
Regards,
Ralph Fucetola JD
www.VitaminIndustryCompliance.com
------ 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.
Thanks,
E.
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.]
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm145320.htm
“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.]
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm145314.htm
“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...."]
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/ucm059049.pdf
“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.]
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/ucm127113.htm
“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
www.easconsultinggroup.com
No comments:
Post a Comment