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The FDA just published an inquiry in the Federal Register to the makers of Dietary Supplements ostensibly to determine if the submission of so-called “structure/function” claims to FDA is a burden.  Please make no mistake:  It’s a trick question

Why is it tricky?  Well there are three possible answers to the question and choosing the correct one is just the first step.  We will discuss this more but first a little background.

When DSHEA passed in October of 1994 it AMENDED the Federal Food, Drug and Cosmetic Act (FFDCA) in some very specific ways.  Sometimes and frankly too often, DSHEA is referred to as a stand-alone piece of legislation and an entity unto itself.  The reality is that it amended an existing piece of legislation in some very important ways.  One of these was in the area of claims that can be made for Dietary Supplements EXCLUSIVELY.  Foods are not allowed to make these claims nor are drugs.  Just Dietary Supplements.  These claims are now called “structure/function claims.  

Rather than opine about what the Law means we shall accept the FDA interpretation for a moment regarding this class of claims and take a look at what DSHEA did in amending the Law regarding these claims.

Quoting directly from DSHEA as it was passed:

“Section 403(r)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)) is amended by adding the following new sentence at the end: ‘For purposes of this subparagraph, a statement for a dietary supplement shall not be considered a claim of the relationship of a nutrient or dietary ingredient to a disease or health-related condition if the statement does not claim to diagnose, prevent, mitigate, treat, or cure a specific disease or class of diseases. A statement for a dietary supplement may be made if the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.' ”

Now this got translated into the language and references within the existing Law (FFDCA) but the intent of the legislation is clear in the plain language of the amendment.  When you look at the amended language of Section 403(r)(1) of FFDCA it comes out like this:

(r)    Nutrition levels and health-related claims.
(1)    Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication—
(A)    characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or
(    characterizes the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition unless the claim is made in accordance with subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as part of the nutrition information required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (.

This is quite a bit different in linguistic terms than DSHEA itself as passed but the reasons are it is an amendment and had to be fit into place.  No bother.  What is important is that the claims themselves are identified now in Section 403(r)(6) as follows.

"(6)    For purposes of paragraph (r)(1)(, a statement for a dietary supplement may be made if—
(A)    the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
(    the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and the statement contains, prominently displayed and in boldface type, the following: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made."

Now here is where it gets interesting.  You see the FDA is now making an inquiry as to whether the burden of notifying the agency concerning these claims is too much.  They are obviously concerned about the terrible price we in the industry must pay for having to send off these letters and so forth.  Nonsense.   This is precisely why FDA’s latest inquiry is a trick question.  First let’s look at the inquiry and what FDA wants to know:

The FDA is inviting comment on the following:
•    whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
•    the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
•    ways to enhance the quality, utility, and clarity of the information to be collected;
•    ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

FDA said it believes the burden on industry of this information collection is “minimal” as the information required is immediately available to companies.

Now let’s look at the three possible answers:

POSSIBLE ANSWER 1.  SILENCE – not saying a word in response to the FDA inquiry is an available option.
However you should be aware that your trade associations are going to say something – that’s part of what you have them around for.  Without your input they will make up their own mind as to the best answers and provide a whole pile of detail surrounding each piece of the inquiry and those inputs may not align with your desires or your positions.  You participate in trade associations (or should) for a reason – to get your voice heard.  Therefore silence is not golden.

POSSIBLE ANSWER 2.  YES – this is a burden to us as manufacturers to have to notify the FDA of each of our claims.  We suffer mightily and wish this burden be lifted.  By the way, now that you ask – the information submitted will not have practical utility and is not truly necessary for the performance of FDA’s functions.
Well – guess what.  This “burden” comes not from the regulations (the things we most often refer to and think of when we think of the notification of structure/function claims (21CFR Section 101.93) but rather the mandate comes from the Law itself.  Thus in order to remove the burden, you must also change the Law.  It is not enough to simply lift the section out of the Code of Federal Regulations.  As you can see in the Law as it exists today, there would be a need for actual statutory change.  Once Congress gets to tinker with legislation, there is no telling what the outcome might be.   A simple amendment can get way out of hand.  There are other linkages within FFDCA to this little “burdensome” section that would also require change and those changes officially open up the ability to remove all traces of DSHEA from FFDCA.

POSSIBLE ANSWER 3.  NO – there is no problem with our having to notify each of these claims.  We hold the substantiation and are more than happy to continue submitting.  Thank you for your concern over our expenditure of time and effort.
All right – this aligns with FDA’s position in the inquiry that it is not a burden to submit these notifications.  What you need to ask yourself is whether you are notifying all of the claims you are supposed to and whether you do hold the substantiation necessary.  Remember that there is a Guidance that issued in January discussing FDA’s current thinking on the matter of what the substantiation requirements should be.  This development has yet to play out in its entirety.  Lastly you also should support the notion that indeed this information is of extreme practical utility for FDA.

Here’s what you need to know:  FDA is thinking hard about the whole “structure/function” claims arena and all that it entails.  There are some deeper issues surrounding the matter you are likely not aware of either that are not the topic of this blog.  The message therefore, is simple:

Your BEST POSITION to advocate to your trade associations for response is a simple response of:  

“NO, you are not unduly burdened by the requirements of the Law to provide notification.”

Please note that this is neither an advocacy of nor a reference to the section of the CFR that is in place.  Advocating conformance to the Law is not a burden.  Such conformance part of how this responsible industry performs.  If you must elaborate further, discussion of electronic submission of the notification (not the substantiation but the actual notification) is an acceptable position.  Leave the rest of it alone.  Most particularly, leave issues of the regulation (21CFR Section 101.93) itself aside and DO NOT EVEN MENTION IT.  Next, continue as you have with your substantiation and notification process.

The topics of “structure/function” claims and their substantiation requirements are getting hotter and hotter these days.  It is important to the overall health of DSHEA that each address of question and each action taken concerning these claims are done carefully.