Guideline No. 13 - Examples of Health Claims in contrast to Therapeutic Claims Digestive System

Health Claims.  Health Claims are defined as claims which support the normal physiological function.  They are not claims for a therapeutic purpose (therapeutic claims) as therapeutic claims make the particular product a medicine under the Medicines Act 1981 and require evaluation by Medsafe and finally Ministerial Consent.   A product is classified as a medicine either because of the ingredient (c.f. the Medicines Classification List) or because of the claim. 

 

Any natural/herbal or dietary supplement product which does not have Ministerial Consent to make a therapeutic claim must confine their claims to "Health Claims" to avoid breaching the Medicines Act.  A "Health Claim" is essentially a claim in support of the normal physiological function or system.

 

Care is needed in health claims to avoid breaching the section 4 [f] of the Medicines Act as a claim of "preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any way" would breach the Medicines Act.  In advertising terms this would mean that verbs like "inhibit", "reduce", "boost", "increase" etc. would all imply either inhibition or acceleration of a normal physiological function and would be potentially a breach of the Medicines Act.

 

c.f. TAPS Guidelines on Therapeutic Claim, Disease State for further explanation and description of the issues re the Medicines.

 

Words like "treatment" "relief from" and "symptoms" "prevention of" "medical", "therapeutic" "symptoms" are generally descriptive of a therapeutic claim and should be used with care to avoid going over the boundary line re the comprehensive definition of a therapeutic purpose in the Medicines Act.  In fact in most cases the use of such wording should be avoided.

 

TAPS has endeavoured to give examples of wording which would be regarded as "health claims".  These claims would therefore be compliant with the Medicines Act and not breach section 4 of the Medicines Act.

 

There are clearly always grey areas regarding claims and it is often the way a claim is worded or the placement of wording which will determine whether a claim is a therapeutic claim or not.  Section 58 of the Medicines Act further defines the  therapeutic claim in relation to about 60 medical conditions listed in the First Schedule of the Medicines Act.  These physiological (medical) conditions are most of the common disease states or conditions.   Whilst the list is not exhaustive it is very broad and covers most common medical conditions for which companies are tempted to make "therapeutic claims".

 

An example is given below in the digestion, gut and bowel area.

Health Claims Only.(These are compliant and would not breach the Medicines Act)

Digestive and Bowel.

 

 

 

Digestive & Gut:

 

"Aids healthy digestion"

"Helps smooth digestion"

"Aids the digestive process"

"Supports normal digestion"

"Aids the normal digestive process"

"Helps smooth the digestive function"

"Aids the digestive function"

"Aids smooth digestion"

"A natural approach for digestion"

"A natural aid for digestion"

"A natural support for the digestive system or function"

"Aids gastric emptying"

"Natural support for stomach emptying"

"Natural aid for stomachs"

"Good for your stomach, naturally"

"Naturally good for your stomach"

"Naturally good for your digestion"

"Naturally good for your digestive tract"

 

For probiotic type products (i.e. introduces commensal or good bacteria to the gut)

This helps to restore the normal bowel flora by replacing some of the good bacteria in the gut.

" Helps restore normal bowel flora"

Helps restore the balance in normal bowel flora"

"Helps maintain the normal bowel flora"

"Aids the normal bowel flora"

"Helps the normal balance of bowel flora"

"Natural restoration of bowel flora"

 

Bowel and Intestine:

 

"Aids the normal elimination function"

"Helps the cleansing process in the gut"

"Aids normal evacuation and bowel movements"

"Supports regularity"

"Supports regular bowel movements":

"Aids bowel regularity"

"Helps maintain bowel function"

"Aids normal bowel function"

"Helps with bowel integrity and function"

"Acts a support to bowel cleansing"

"Supports bowel cleansing and elimination."

"The aid for bowel cleansing"

"The aid for bowel function and elimination"

"Aids normal gut motility"

"An aid to gut and intestinal motility"

"Aids natural intestinal cleasing"

"Supports natural elimination"

"Helps natural intestinal function"

"Helps natural bowel regularity"

"Aids elimination function"

"A natural approach for bowel function"

 

Claims for a therapeutic purpose-Therapeutic Claims.   (These are non-compliant and would breach the Medicines Act if such claims are made by natural/herbal/dietary supplement products.

Gut and upper digestive tract.

 

"Relieve dyspepsia"

"Treats indigestion"

"Treats acid stomach and dyspepsia"

"Relieves acid stomach"

"Treats reflux disease"

"Relieves symptoms of gastric or duodenal ulcer"

"Treats gastric or duodenal ulcer"

"Relieves excess stomach acid"

"Relieves the pain of dyspepsia"

"Relieves pain of gastric ulcers"

"Prevents indigestion"

"Prevents dyspepsia"

 

Bowel and lower digestive tract.

 

"Treats the symptoms of Irritable Bowel Syndrome (IBS)"

"Relieves symptoms of Irritable Bowel Syndrome (IBS)"

"Relieves gut or intestinal pain"

"Treats or relieves constipation"

"Relieves symptoms of Crohn's Disease"

"Acts as a laxative" -(a laxative is a class of medicine")

"Relieves spastic colon"

"Relieves or treats the discomfort of Irritable Bowel Syndrome"

"A natural medicine for Irritable Bowel Syndrome" -this implies it can be used instead of a registered medicine.

"A natural alternative for Irritable Bowel Syndrome" -this also implies that the natural product can be used instead of a registered medicine.

"A natural approach to bowel disease" -mention of disease makes this claim a medicine by implying a treatment for disease.

"A natural treatment for bowel disease or Irritable Bowel Syndrome (IBS) -use of the word treatment implies a medicine.

 

A note on "Irritable Bowel Syndrome" (IBS).  A syndrome is defined by Dorland's Medical Dictionary as " a set of symptoms occurring together" or "the sum of signs of any morbid state" or "a symptom complex".  This is essentially a similar set of symptoms occurring together in a defined medical condition.  In this case it is "Irritable Bowel Syndrome".  Because a "syndrome" is a set of symptoms then this clearly denotes it as a medical condition or disease state for which medical treatment is required.  With IBS there is variable abdominal discomfort or pain, and constipation, diarrhea, or alternating episodes of each as some of the symptoms making up the syndrome. C.f The Merck Manual.

NOTE:  Generally use of words like "alternative" or "natural" will imply that the product can be used instead of a medicine which has Ministerial Consent for a therapeutic purpose.  This is both misleading and potentially risky for the consumer in that it could delay appropriate medical treatment at an early stage.  For this reason herbal and natural products would be likely to breach the Medicines Act by making such claims and using such wording.

As mentioned these are examples only of the two types of claims (health and therapeutic) in the gut and bowel area.  It is hoped that these examples will help to clarify the difference between a "health" and a "therapeutic claim" and will also help to clarify the TAPS Guidelines on the issue of therapeutic claim and disease state. It does not pretend to be exhaustive but is a guide only.