THE LATEST FROM FOCAL POINT RESEARCH

Cannabis Regulatory Proposals for Upcoming Legalization in Canada

Cannabis Regulatory Proposals for Upcoming Legalization in Canada

With Cannabis legalization coming this year in Canada, people are asking a lot of questions about how it will be regulated and prevented for use by underage youth. The federal government announced a consultation paper in which they outline cannabis regulatory proposals for authorizations, security, product packaging and labelling, cannabis in health products, cosmetics, and more. While the federal government is responsible for the licensing of cannabis and its derivatives, provincial governments authorize distribution and retail sale. Additionally, the minimum age requirement and the maximum amount of cannabis an individual may possess is at the discretion of the provinces, therefore there may be variations among provinces. As of now, the federal Cannabis Act will allow the production and sale of dried cannabis, fresh cannabis, cannabis oil, cannabis plants and cannabis seed. Currently, there are prescription drugs containing cannabis, with parts of the cannabis plant that fall under the Controlled Drugs and Substances Act. Non-prescription health products such as natural health products, and medical devices, and non-prescription drugs may have cannabis present – although it is only the parts of the cannabis sativa plant that are not under the Controlled Drugs and Substances Act, or [...]

Learn more

Proposed Amendments for Increased Transparency in Drug and Medical Device Clinical Information

Proposed Amendments for Increased Transparency in Drug and Medical Device Clinical Information

In drug submissions and medical device applications, clinical information provided by the manufacturers is treated as confidential business information by Health Canada. However, since the development of Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act) there have been calls for increased transparency within drugs and medical drugs. As a result, Health Canada had announced their intention to amend the Food and Drug Regulations as well as the Medical Devices Regulations to allow for public release of clinical information submitted to Health Canada by drug and medical device manufacturers. This disclosure of confidential information to the public will allow health professionals and researchers to perform independent analyses of the published research findings, identifying or responding to possible risks of the health of Canadians as well as promoting greater confidence of the drug or medical device. This amendment will mirror the European Medicines Agency and the U.S. Food and Drug Administration who have had clinical data transparency for over 10 years. Manufacturer clinical information that will cease to be confidential once the amendment passes includes:

  • clinical summaries,
  • reports and supporting data of clinical trials submitted to Health Canada in support of a drug submission or,
  • reports and supporting data [...]

Learn more

Maui Plans to Ban Oxybenzone and Octinoxate Containing Sunscreens in Effort to Protect their Coral Reefs

Maui Plans to Ban Oxybenzone and Octinoxate Containing Sunscreens in Effort to Protect their Coral Reefs

After having a first-hand look at the impacts of dangerous chemicals on marine environment and wildlife, the Hawaiian island of Maui has proposed a bill preventing the sale and use of SPF sunscreen containing oxybenzone and octinoxate within the region. Maui, like the rest of the state of Hawaii, is heavily reliant on its natural beauty to attract visitors all over the world.  It is known as a great spot for snorkeling due to the presence of its coral reefs.  However, recently Maui’s famous coral reefs have been bleaching and dying.  There are many factors that cause coral bleaching, such as high ocean temperatures, but studies have determined that corals exposed to oxybenzone and octinoxate, popular sunscreen actives, exhibit signs of bleaching as well.  Oxybenzone and octinoxate are known to be toxic to coral reefs at 62-280 parts per trillion (ppt) and 10-220 ppt respectively.  Samples, taken by Haereticus Environmental Laboratory, of snorkeling spots around Maui have found levels of up to 4000 ppt oxybenzone and 1500 ppt octinoxate. The ban is widely supported by residents as they believe it would help protect coral reefs from bleaching.  Also, oxybenzone and octinoxate are also known to affect the development and [...]

Learn more

Microbead Ban and its Effect on the World’s Oceans by the Numbers

Microbead Ban and its Effect on the World’s Oceans by the Numbers

With the recent plastic microbead ban in the United Kingdom coming into force and Canada’s ban effective summer of this year, there are questions about the use of plastic microbeads and the controversy surrounding them and why they are being banned in cosmetic products in more and more countries. Microbeads are less than 1mm (or 1/25 in) in diameter and were used as exfoliants in many cosmetics and toiletries.  Because microbeads are made of plastic, they can’t dissolve. Due to their small size, they are not properly filtered in wastewater treatment and are easily expelled into oceans and lakes, even consumed by marine organisms.  In a 2015 study it was found that more than 800 trillion plastic microbeads were washed down the drain every day in the US alone.  Worldwide, this contributes to the 93,000 to 236,000 tonnes of microplastics (from various sources) that accumulate in the ocean every year. This strict regulation on plastics in cosmetic products should be extended to plastic products beyond the cosmetic sector.  There is an average of 8 million tonnes of plastic that enter the world’s oceans every year.  Plastic microbeads from cosmetics would make up a small fraction of ocean [...]

Learn more

Legal Responsibility for Generic Drugs

Legal Responsibility for Generic Drugs

When prescribed a drug product, patients can receive the brand-name variety or a generic drug.  Generic drugs have the same pharmacological active ingredients as their brand-name counterpart but are sold at a lower cost, simply because generics are produced when the patents and exclusivities of the brand-name drug end . A major difference between the two types of products, is that generic drugs do not require the same inactive ingredients as its brand-name version.  Thus, depending on the individual, a person may have differing reactions to generic drugs based on the inactive ingredient present. According to the FDA, generic drugs must be sold with the same label as of the brand-name variety despite the two being manufactured and regulated differently as well as possibly containing different inactive ingredients. This detail led a brand-name drug manufacturer into trouble last month.  The Supreme Court of California ruled against Novartis, a brand-name drug manufacturer, holding them liable for failing to warn the proper risks in the generic drug labels. This came after a generic drug label, terbutaline, failed to warn of its risks for pregnant women and led to deficiencies in fetal brain development.  Prosecutors claimed Novartis was responsible since generic [...]

Learn more