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Logo, Lingos and Labels

BY Clarice Oelofse

Today we are talking about supplements...
 
The Dietary Health Education Act (DSHEA) which was passed in America in 1994, defined a dietary supplement as a product (other than tobacco) that:

  • Is intended to supplement the diet
  • Contains one or more dietary ingredients (including vitamins, minerals herbs or other botanicals, amino acids and other substances) or their constituents
  • Is intended to be taken by mouth as a pill, capsule, tablet or liquid and
  • Is labelled on the front panel as being a dietary supplement

Unlike drugs, products that fell into this category could be marketed and sold without having to undergo a rigorous process of research, pre-market review and approval by the FDA (the Federal Agency in the USA that oversees both drugs and supplements, equivalent to the MCC or Medicines Control Council in South Africa). The manufacturer thus became responsible for proving that its products are safe and that the label claims are truthful and not misleading.
  
Don’t be fooled by sales talk such as “It is natural & safe”. Herbal supplements are not any more effective or safe than unnatural ones, and herbals sometimes naturally contain active ingredients that interact with each other or with medications.
 
Logos
Several independent organisations quality test products and provide their logos (seals of approval) if products pass these tests. Although the logo states that the product has been tested for prohibited substances, it is important to know to what extent batches were tested.
 
Labels
South Africa does not currently provide a system which regulates what tolerance for discrepancy is allowed in respect of labelling of products such as this. In the premises, it is submitted that the parameters set out by the United States Food and Drug Administration (FDA) may be of assistance. The FDA’s Guidance for Industry: Nutrition Labelling Manual – A Guide for Developing and Using Data Bases is a guidance document written by the Center for Food Safety and Applied Nutrition at the FDA. It assists industry in the task of preparing nutrient information for labels and labelling that meet the requirements of FDA regulations.
 
Sometimes ingredients are disguised by the use of pseudonyms. For example geranium might be methylexanamine, methylsynephrine is oxilofrine, ma huang is a plant source of ephedra, citrus aurantium is a source of synephrine and Acacia rigidula may contain phenpreomethylamine.

Decoding the labels - watch out for these red flags on labels:

  • Cures or treats or prevents disease - It is illegal for supplements to make health claims
  • Real Results, Fast! - No magic in a bottle, no quick fixes
  • Proprietary Blend - Secretive strategy of not declaring individual ingredients – may contain trace amounts of cheap fillers

In spite of the FDA making the statements that "dietary supplements are products intended to supplement the diet" and that "they are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases" many supplements are sold on the premise of being both powerfully beneficial (with drug-like side effects) and harmless.
 
This raises an important question: "If a substance has powerful effects, surely it should be regarded as a drug" (Fontanorosa et al: 2003). 
 
The MCC has proposed an additional category, ‘health supplement’, to be included in the definition of a complementary medicine. This category requires to comply with parameters that were to be furnished in a guideline, that would define the requirements for the claims for efficacy, quality, safety, etc. This has now been formally released. This document, released on the 20th November, is a draft released for comment by 26 February 2015.
 
The purpose of this Guideline is to provide clear guidance with regard to the quality, safety and efficacy (QSE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa. The intent of this document is to ensure that the levels of evidence for QSE are rigorous enough to protect public health and maintain consumer confidence, while providing a clearly defined pathway to register health supplements.
 
The document is available here.
 
Sources:
www.camcheck.co.za
Supplements: Help, hype or hindrance (Module 1: Introduction)
 
p.s. FACTS is presenting a Labelling Workshop in Port Elizabeth on 14 July 2015. Cost is R1 500 pp ex VAT. Contact info@entecom.co.za for more information.

 July 01, 2015
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Food Safety
Clarice Oelofse

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