Health Claim Strategies for Food and Drinks Companies

This report considers the implications of the adoption of EC Regulation 1924/2006. In addition to summarizing the results of the new legislation, the report examines what options now face manufacturers in this sector, what strategies can be employed to navigate the new regulations, and what opportunities have emerged due to the changing regulatory environment.

• Examine the breakdown of the claims evaluation process to date: the winners and losers of EFSA's decisions.
• Assess the breakdown of approved health claims by indication.
• Understand the implications of the new legislation in terms of which health claims will have to be removed from the market.
• Examine how vitamins and minerals can be used to maintain the use of certain health claims.
• Assess the future claims landscape and explore possible market opportunities and challenges.

The claims evaluation process has yielded 222 authorized health claims made up of 87 vitamin claims, 77 mineral claims, 11 fatty acid claims, six fiber claims and 41 "other" claims. Among the vitamins, vitamin C is the absolute winner and most versatile health vitamin with 15 authorized health claims: 7% of the total health claims authorized.

Among the minerals, zinc has been proven to offer many health benefits and has an amazing 18 authorized health claims: 8% of the total health claims authorized. Second best is magnesium (10 claims, 5% of total), followed by calcium and copper (both with eight claims, roughly 4% of total).

Coenzyme Q10 is an example of an ingredient that, despite being associated with energy-boosting benefits, has failed to secure an approved health claim. However, it may be possible for a manufacturer of a CoQ10 product to add 15% of the RDA for vitamin B6 in order to maintain the use of a claim like ”provides more energy” or ”combats fatigue.”

• Which ingredients have received approved health claims and which have failed to secure EFSA support?
• Which therapeutic areas have been the focus of approved health claims?
• What are the most notable health claims that have to be removed from the market by December 14, 2012?
• How can manufacturers limit the damage caused by this legislation and potentially maintain the use of health claims?
• How can manufacturers adapt their claims strategies moving forward?

Table of contents

About the author
Disclaimer
Health claim strategies for food and drinks companies
Introduction
About this report
The claims evaluation and authorization process
EFSA evaluation
Review by European Commission and member states
Authorization by European Parliament
Other EU and national provisions remain in place
The permitted health claims list
Claims for vitamins and minerals
Claims related to high profile health benefits
Regulation adoption: the fallout
Longstanding health claims to be removed
Areas of uncertainty remain
Phrasing an authorized health claim
Guidance by national enforcement authorities
Future claims landscape
Market opportunities
Market challenges
How to move a claims strategy forward
Generating new data
Choosing the right trial partner
Conclusions
Appendix
Scope
Methodology
Glossary/abbreviations
Bibliography/references

TABLES
Table: EU authorized health claims and related health relationships for zinc
Table: EU authorized health claims pertaining to the immune system
Table: EU authorized health claims pertaining to digestive health
Table: EU authorized health claims pertaining to body weight management
Table: EU authorized health claims pertaining to blood glucose management
Table: EU authorized health claims for which EFSA found no evidence of deficiency in the EU population leading to impaired function of the health relationship
Table: EU authorized health claims related to micronutrients and reduction of tiredness and fatigue
Table: What does it take to get a health claim approved?
Table: Requirements for successful, pertinent clinical trial

FIGURES
Figure: Health claim regulation timeline, 2007–12
Figure: Substance distribution of EU authorized health claims
Figure: Hierarchy of scientific evidence
Figure: SWOT analysis for an academic group as a trial partner
Figure: SWOT analysis for a CRO as a trial partner

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By sector: Health (in Soft drinks), General drinks