The Natural Health Products Protection Association
600 – 235 First Avenue
Kamloops, B.C.
V2C 3J4., Tel. 250-372-1404 Fax 250-374-5800,
Shawn Buckley , one of the founders of the NHPPA , is a lawyer with expertise in the Food and Drugs Act and Regulations. Mr. Buckley acts primarily for manufacturers of Natural Health Products and has an enviable track record in protecting companies charged by Health Canada. www.healthcanadaexposed.com
Peter Helgason has spent the last six years as the Regulatory Affairs and Contact person for the Strauss Herb Company. He has spent the past six years networking in Canada and the world finding capable, ethical people who support the rights of small businesses, practitioners and consumers to access, manufacture and sell Natural Health Products.
"There has been a lot of talk about 60% of Natural Product License applications failing by either being refused or withdrawn after deficiency notices were sent. This is clearly a startling number as if the trend continues, it will mean that over half of the products currently on the market will have to be taken off of the market.
The Failure of Multi-Ingredient License Applications is Estimated to Become 80-90%
The current 60% failure rate for product license applications has mainly involved applications for single-ingredient products. This means that 60% of single ingredient NHPs have failed to pass Health Canada's stringent safety and efficacy standards. The difficulty in meeting Health Canada's standards increases with each ingredient. Because of this many are estimating that 80 to 90% of multi-ingredient NHPs will become illegal when their license applications fail.
What Natural Health Products Will be Left Once Health Canada is Finished Judging 60% of Single-Ingredient NHPs Illegal and 80-90% of Multi-Ingredient NHPs Illegal ?
Because Health Canada has been so slow to process license applications, NHP manufacturers and retailers have not yet had to decide what they will do when the overwhelming majority of their products are deemed illegal.
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| The Natural Health Products Protection Association is federally incorporated as a non-profit company with the sole object of: Protecting access to Natural Health Products and Dietary Supplements. By limiting its purpose to protecting access to Natural Health Products and Dietary Supplements, the NHPPA will focus on identifying and responding to threats facing the Natural Health Product and Dietary Supplement industry. | ||||||||||||
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When consulting industry members on the structuring of the NHPPA, small and medium sized manufacturers voiced concern about the NHPPA being taken over by large companies if a membership organization structure was adopted. Whether or not this concern is warranted, there is a perception that some trade organizations in both Canada and the U.S. operate for the benefit of large members when the interests of large and small manufacturers conflict. For example, the Natural Products Association and the Council for Responsible Nutrition in the U.S. were cited as groups supporting the FDA’s Interim Final Rule on Good Manufacturing Practices for Dietary Supplements. Support for this Interim Final Rule is viewed as significant in that the new GMPs are expected to drive many small and medium manufacturers out of business. The FDA states in the Rule: "We find that this final rule will have a significant economic impact on a substantial number of small entities…Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business. The regulatory costs of this final rule will also discourage new small businesses from entering the industry. The DS [industry] has been characterized by substantial entry of small businesses". Because the NHPPA views the survival of small and medium manufacturers as vital to the NHP industry, it was decided to adopt a board-only structure. Voting membership will be limited to 5 to 7 members who will be responsible for electing the NHPPA Board. This will prevent the NHPPA from being taken over to promote the interests of one segment of the industry at the expense of other segments of the industry. | ||||||||||||
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| The NHPPA will involve its stakeholders in the decision making and direction of the organization by taking direction from an Advisory Board of stakeholders. There is currently an interim Advisory Board fulfilling this role. A final Advisory Board will be selected annually by those NHPPA stakeholders who join the NHPPA as Associates. All NHPPA Associates will also have the right to submit proposals and comments to both the Advisory Board and the NHPPA Board. | ||||||||||||
Become an NHPPA Associate
The NHPPA is inviting any person, company or group with an interest in protecting access to Natural Health Products and Dietary Supplements to join the NHPPA as Associates.
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Why Join the NHPPA ?
The Natural Health Product Industry is under immediate threat. For example:
the majority of NHP License applications are being denied under Regulations that were to legitimize the industry. At this point almost 60% of license applications have been either refused or withdrawn. These are primarily license applications for single ingredient products. The NHPPA expects that the percentage of license refusals will increase to 80-90% as the NHPD starts considering multi-ingredient products. In short, the industry will remain largely illegal, or the majority of NHPs will have to be taken off of the market;
the new NHP Regulations are driving small and medium manufacturers out of business;
manufacturers continue to drop low selling Natural Health Products due to the high cost of compliance;
the NHP Regulations unduly increase the cost of products;
the NHP Regulations drive products from the market that Canadians depend upon for their health;
innovation on new products is grinding to a halt as it becomes clear that novel multi-ingredient products will not pass Health Canada’s scrutiny without drug-style evidence in the form of clinical trials;
natural health products that consumers, retailers and distributors depend upon are stopped at the border due to non-compliance with the NHP Regulations.
The NHPPA is ideally suited to deal with this immediate threat.
There is a pressing need for an organization that is positioned to take a leading role in uniting both the stakeholders and the other interest groups in the industry. The leading consumer groups have already expressed a desire to work with the NHPPA in forming a coalition. ALL OF THE LEADING CONSUMER GROUPS ARE NOT WILLING TO WORK WITH ANY OF THE EXISTING TRADE AND INTEREST GROUPS SUCH AS THE CHFA and the Canadian Coalition for Health Freedom. Several manufacturers, retailers and distributors have advised the NHPPA that they are not willing to work with the CHFA and organizations such as the Canadian Coalition for Health Freedom. The NHPPA MAY BE THE ONLY ORGANIZATION CAPABLE OF CREATING THE COALITION NECESSARY TO ADDRESS THE IMMEDIATE REGULATORY CRISIS.
The NHPPA will be able to include those stakeholders that for whatever reasons are unwilling to work with the other industry groups.
The NHPPA will seek to work with all other industry groups to bring about regulatory change and in this way can act as a bridge between those groups and stakeholders and consumer groups currently unwilling to work with them.
bullet Strategy for Immediate Regulatory Threat
The current regulatory crisis is not the issue threatening the NHP industry. Although the Natural Health Product industry is facing an immediate threat with the imposition of the drug-style NHP Regulations, there are other threats lurking in the background. These threats include:
international treaties Canada and the United States are participating in such as CODEX;
the imposition of ever stricter standards upon the industry by Health Canada and the Food and Drug Administration in the United States;
the seizure of products at the border between the United States and Canada. Currently, the main problem is U.S. products entering Canada. However, with the imposition of stricter standards on dietary supplements by the F.D.A., there is a real risk that the F.D.A. will adopt the Health Canada approach of stopping products at the border;
Stakeholders are currently not being kept up to date on these issues. NHPPA Associates will be kept up to date on these issues and will have input in to how the NHPPA should be working to protect Associates from these threats.
Contact Us
Contact us by mail at:
Natural Health Product Protection Association
#2 – 953 Laval Cres.
Kamloops, B.C. V2C 5P4
Contact us by email at: hrondeau@nhppa.org
Contact us by fax at: 866-789-1416
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