Dicentra Bi-Weekly Regulatory Updates

August 26, 2011 By

Health Canada

Natural Health Products Directorate – NHPD


NHPD Releases its Status of Applications Quarterly Report: Quarter 1

  • NHYPD has received 62201 PLA from Jan 1, 2004 to June 30, 2011.
    • 85% PLAs completed
    • Issuance of 29011 product licences, representing 39973 products.
  • Of the 10885 PLAs and amendments received before August 5th, 2010 (pre-UPLAR PLAs), 3561 have been completed or are in the process of being completed.
    • NHPD committed to completing the remaining 7324 applications before NHP-UPLAR is repealed in February 2013.
  • Of the 9697 applications and amendments received on and after August 5th, 2010 (post-UPLAR PLAs), 48% fully meet NHPD’s pre-cleared information (60 day target) and 52% require full assessment (180 days review target)
  • Performance Targets:
    • 30 day initial assessment: 96%
    • 60 day pre-cleared information: 98%
    • 180 day full assessment: 97%
  • NHPD received 1826 Site Licence Applications from Jan 1, 2004 to June 30, 2011
    • 1770 SLAs have been completed
    • Issuance of 1198 site licences
    • 2174 Site Licence Renewals have been received
    • 96% of all Site Licence renewals have been completed.
    • Quarter 1: 45 SLAs received, 99 Site Licence Renewals received
      • 63 SLAs completed
      • 114 Site Licence Renewals completed.
  • NHPD received 347 Clinical Trial Applications (CTAs) between Jan 1, 2004 and June 30, 2011
    • 324 CTAs have been completed
    • Issuance of 277 notices of authorization
    • Remaining were refused or withdrawn by the applicant.
    • Quarter 1: NHPD received 15 CTAs and 9 CTA Amendmens
    • 15 CTAs completed
    • 9 CTA amendments completed.




EFSA launches public consultation on draft guidance for the risk assessment of food and feed derived from GM animals and related animal health and welfare aspects

August 10, 2011

Guidance document outlines specific data requirements and the methodology to be followed for risk assessment should applications for food and feed derived from genetically modified animals be submitted for market authorization in the European Union.


Public consultation on a draft guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.

  • Deadline: August 31, 2011


Public consultation on a draft guidance on the scientific requirements for health claims related to bone, joints and oral health

  • Deadline: August 31, 2011


Public consultation on a draft guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

  • Deadline: August 31, 2011


Medicines and Healthcare products Regulatory Agency


Press release: Public warning against buying dangerous herbal slimming aids online

  • Several products available to buy from overseas websites have received international safety warnings and alerts from health agencies in Sweden, Canada, Australia, Hong Kong and the US. Products including ‘Instant Slim’, ‘Acai Berry ABC’ and ‘Sport Burner’ have been found to contain the prescription-only substance sibutramine which has been withdrawn across Europe due to increased risk of heart attacks and strokes following use.




Shift in practices for marketing food products with health benefits imminent in EU

  • 2010 will see advertising messages across the functional food market moving in a new direction as the European Commission begins to finalize its draft article 13.1 “Union List” of permitted health claims.
  • Once the article 13.1 transition period expires, food companies will face the challenge of having to develop alternative ways of marketing and advertising to communicate health and other benefits of products.


American Herbal Products Association


AHPA Clarifies Its Position on the Science Linking DMAA to Geranium Oil; New Research on DMAA in Geranium Reported

  • The trade requirement, which becomes effective on January 13, 2012, requires that AHPA members do not label 1,3-dimethylamylamine, whether identified by this name or any synonym, as geranium oil or as any part of the geranium plant, whether by the common name of geranium or by the botanical name of any plant known as geranium.
  • In an August 8 statement to announce this policy, AHPA referenced a review of one published study that reported DMAA as a naturally occurring constituent of the geranium species, Pelargonium spp. In this announcement, AHPA inadvertently stated that there are no known-published reports indicating that DMAA is a natural product. This was a misstatement since the announcement noted the study, by Ping et al. (Ping Z, Jun Q, Qing L. A study on the chemical constituents of geranium oil. Journal of Guizhou Institute of Technology 1996;25:82-85), which identified the presence of DMAA in geranium.
  • In the interim, AHPA has been informed by an analytical chemist and an AHPA member that they have initiated new research on the chemistry of geranium. Both have reported that their preliminary results indicate the presence of DMAA, and some effort to validate these results is now planned.

AHPA Launches New Website to Inform Industry about Tainted Products Being Sold as Supplements

  • The American Herbal Products Association (AHPA) has launched a new website called KeepSupplementsClean.org, which is designed to keep the dietary supplement industry informed on issues related to illegal tainted products being sold as dietary supplements.

Natural products Insider


EHPM: EFSA Should Expand 13.1 Claims Evidence

  • The European Federation of Associations of Health Product Manufacturers say EFSA should go beyond intervention trials when it determines article 13.1 (General function) claims evaluations.
  • Essential that the totality of data is weighted by assessing the strength and consistency of data.
    • Example: EFSA’s approach cannot confirm that a diet rich in fruits and vegetables promotes heart health.




China set to slash approved health claims by a third

  • In 2009, China passed the Food Safety Law which included 27 approved health claims.
  • Claims for sleep and fatigue were not supported by human clinical data and could be revoked.


British botanical group welcomes “new era” in herbal products in Europe

  • The British Herbal Medicine Association supports the Traditional Herbal Medicinal Products Directive.
  • Will increase the credibility of the sector by improving product quality, standardising claims and boosting public confidence in herbal products.