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A New NHPD Monograph Coming Soon?

Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due to a variety of factors, such as new and emerging science breakthroughs and public health threats worldwide. The modernization is also based on public input regarding the need for greater transparency. The Canadian federal government published a Red Tape Reduction program in January 2012, and some of the reasons for change also stem from this report.

The NHPD recently released a Standards of Evidence document that is currently under consultation review by stakeholders. This consultation review is set to end August 21, 2012. The document takes a risk based approach to health claims and may allow lower risk claims to be made based on non-human studies (e.g. In vitro animal studies) as long as safety data in humans is available. Essentially this review and licensing will be based on three class levels, each having a level of risk. In addition to this license evaluation approach there are new timelines proposed. The chart below illustrated the current and future timelines:

ClassCurrent TimeframeFuture timeframe
1 – High level of certainty
– (eg. Monographs, AbLs, Category IV/TPD labeling
60 days10 days
2 – Medium level of certainty – a combination of pre-cleared information and high quality data from peer reviewed published journals180 days30 days
3 – Low level of certainty – clinical trial evidence and full pre-market assessment180 days180 days

Based on the amount of information that the NHPD has gathered over the last 8 years and pre-cleared information through NHPD monographs, the anticipation is that 99% of all product license applications would be reviewed in 30 days or less. With the Exemption number program set to expire in February, the NHPD is under the gun to clear the backlog and introduce a new process. After UPLAR expires in February, the mandate will be in place so that products will not be allowed for sale unless an NPN is issued.

These new target review timelines are a major requirement forcing companies to set dates for products on shelf with their retail partners. The new framework will hopefully prevent any future backlogs. Based on the rapid response that Quality Smart Solutions has seen in the past year, from license submission to license issuance for our clients, it is encouraging that the NHPD will meet their target of clearing the backlog and repeal UPLAR without further extension of the regulations past the due date. We also anticipate many more monographs to be published between now and next February. Quality Smart Solutions will keep you updated as this new approach develops and becomes reality.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Beware: More Bullets in Russian Roulette Game With The FDA!

Often the dietary supplement landscape in the United States has been referred to as the “Wild, Wild West” with many companies taking the approach of “gunslinger,” thinking they can say anything on their label in terms of both marketing and health claims. Many companies have done due diligence to be compliant with FDA and FTC regulations. Others are playing Russian roulette with the FDA & FTC, stating unsubstantiated structure-function claims or even preventative claims (which are not allowed on U.S. labels for dietary supplements) with their advertising and marketing material.

Fortunately, the FDA is taking a more aggressive stance on this and sending warning letters, which can go as far as issuing a recall or stopping the sale of products. The FDA action doesn’t just target marketers of dietary supplements, it targets the manufacturers also. Inspection of dietary supplement manufacturers, packagers, labelers and storage facilities has shown some to be non-compliant. If non-compliance is observed these sites are issued an FDA Form 483. If a “483” is not responded to with corrective and preventative actions, warning letters will be issued.

The FDA is arming their “compliance gun” with more bullets so that fewer dietary supplements can get away with playing the game of Russian roulette. Some of these “bullets” include:

  • No prior notice to conduct site audits
  • Checking more dietary supplement labels to ensure that claims made are substantiated, not misleading, and are not preventative claims. Since products may be sold at retail locations or online, FDA agents are checking these outlets more frequently.

You DO NOT want to be playing games with the FDA. The damage goes beyond a recall. Public notices are sent out by the FDA on their official website and through various media outlets. With social media picking up these feeds, a company’s reputation could be permanently ruined and it could mean the end of business.

Quality Smart Solutions is your dietary supplements regulatory partner. Have us be your due diligence “eyes and ears” for your product packaging, labeling and marketing to ensure that you are FDA and FTC compliant.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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News

Keeping An Eye On The Global Health Products Landscape

Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how the world is evolving into a single global marketplace. Products marketed in the United States may be in Brazil after having cleared the regulatory hurdles of that country. Products made in Korea may be in Canada after receiving an acknowledgment letter or NPN. With globalization, various regulatory hurdles must be overcome for each country or region where entry is desired. Quality Smart Solutions is involved in this global market, and our clients span the globe. We will keep you informed through news feeds which we regularly update on our website.

Other ways to follow Quality Smart Solutions are:

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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News

Thank you for visiting us at the NATURAL PRODUCTS EXPO WEST in Anaheim, California in March!

We hope you found it as successful as we did. Feel free to email us at

info@qualitysmartsolutions.com or give us a call at 1-800-396-5144.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation