Do as I say, NOT as I said.

As we press onward in our never-ending search for the reality of the regulatory structure we live in here in the United States, it seems that we are forgetting history.  And by WE I mean all of us.  The industry members, the FDA – everyone who is presently involved has forgotten what went before.  What triggered this epiphany was a review of some claims a company wanted to make concerning a product or two intended for release into the market.  The company crafted the claims carefully, insured that substantiation existed for the claims intended to be made and were ready to go.  Then, a review of extant (not historical) FDA responses to similar claims stopped the whole process short.

Now, the historical perspective goes all the way back to 2000 – and actually goes back farther than that, but for the discussion here, the operable date is but seven years ago.  The Federal Register notice of January 6 of that year contained (on pages 999 through 1050 the section titled: Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Final Rule.  This is the regulation now found in the Code of Federal Regulations at 21CFR Section 101.93.  What is not contained in the CFR is the history (in this case the discussion that was part of the posting way back in the year 2000.

I have long held the position that FDA is slowly but surely narrowing the claims that supplements can legally make by opinion and fiat and not in accordance with the Law – you know the Federal Food, Drug and Cosmetic Act.  Anyway, here’s a bit more proof.

The claims at issue by this company involve a product intended for support of joint health.  A glimpse into history now provides some of the perspective applied in crafting the claims desired.

On page 1013 of this Federal Register notice FDA states:

“FDA does not agree that the final rule eliminates all meaningful claims for dietary supplements. FDA believes that there are many meaningful structure/function claims that can be made without implying disease treatment or prevention, and has listed a number of such claims in this preamble.”

This would seem to be great news.  The comments to the Proposed Rule inquired and FDA answered.  What a wonderful outcome.  Or so it seemed.  But to reinforce this statement, FDA also said (across pages 1016 and 1017):

“The claim ‘helps support cartilage and joint function,’ on the other hand, would be a permissible structure/function claim, because it relates to maintaining normal function rather than treating joint pain.” [emphasis added]

FDA had additionally clarified its position on pain relief claims as follows:

“FDA agrees that some minor pain relief claims may be appropriate structure/function claims for dietary supplements. A claim that a product is intended to treat minor pain, without reference of any other conditions, symptoms, or parts of the body that would imply disease treatment or prevention, would be an appropriate structure/function claims, because minor pain, by itself, can be caused by a variety of conditions, not all of them disease-related.” [Found at Page 1030 – again emphasis added]

Wow.  So pain claims can be made (as long they aren’t joint pain claims) and joint health claims can be made (as long as they don’t involve the mention of pain.  Not so fast.

In 2004, FDA sent a “courtesy letter” to another company stating that the claim “[R]educing pain due to everyday activity . . . . [is] a disease claim because it suggests that the product is intended to treat, prevent, or mitigate diseases, namely joint disorders such as arthritis, when consider in the context of the other claims regarding the promotion of joint health, mobility, comfort and cartilage integrity and C-reactive protein levels.”  [still more emphasis added]

Therefore, you cannot have a product capable of accomplishing both outcomes (relief of pain and promotion of joint health).  That is you can have a product – you just can’t tell anyone what it does.  Once again we have stepped through the looking glass of the FDA’s view of dietary supplements.  In spite of the fact that FDA publicly stated that joint health claims could be made and that pain relief claims could be made – you cannot make them in the labeling of a single product.  Where this logic comes from is anyone’s guess but there it is.  The intended claims for the joint product that is the genesis for this posting is one that has ingredients that perform both functions.  The intended claims were lifted directly from this cited Federal Register notice as being “acceptable” by FDA.  Yet, the precedent set by what FDA now SAYS rather than what it SAID eliminates the opportunity to make these claims.

Another “courtesy letter” issued in 2005 disallows the claim “Reduces Pain.”  If that phrase sounds familiar it should – it was posted in the Federal Register notice.

You see, as time passes we all tend to forget that which has gone before.  Like FDA forgetting that they allowed specific claims and offered the opinion that such claims were fine.  It seems the context is the thing here and FDA continued in its reasoning in 2004 that:

“We stated that since pain is not a normal state, nor are there ‘normal pain levels’” a claim about pain treatment or prevention is ordinarily a disease claim.”

This was an obvious reference to their statements made in that silly old 2000 Federal Register notice.  Funny that.  If one takes the time to review the history, here is what FDA had to say “in context.”

“FDA does not agree, however that general well-being or health maintenance claims would encompass such pain claims. Pain is not a normal state, nor are there ``normal pain levels.’”

The context of their excerpted statement was one of general well-being.  The disallowed claim presentation was not at all aligned with this.  Disallowance of claims previously allowed without following regulatory procedure is not only inappropriate, it is in violation of the same United States Code that FDA contends it is upholding.

The point to all of this is that we, as an industry, face a large number of challenges.  It is fully time for us to challenge back.  This action would take the place of inaction, or non-compliance in acknowledgement of FDA’s complete lack of enforcement of the existing regulations – that is unless you submit your claims as mandated by the regulations and allow for FDA to ignore or rewrite history.

The hope here is that someone somewhere will have the gumption to stand up to this incredible revisionism and stop the process of claims elimination.  I once wrote an article (and a bit of commentary to the Proposed Rule that preceded this Final Rule) that discussed FDA’s intentions as to claims.  The apparent fear is that the consumer will learn too much about the products they use from sources other than the FDA.  In the end, unless we, as an industry, do something constructive, the only claims we will be allowed to make will be:

“This is a REALLY Good product.  We can’t tell you what it’s good for or what it does but it is REALLY Good.”