The Organic and Natural Health Association launched in October 2014, and in these past eight months, we have launched several bold initiatives in support of our mission to create a sustainable future by advancing and growing the organic and natural marketplace. This organization of consumer and corporate entities is deeply committed to four guiding principles:
- Sustainability, supporting food, farm and goods productions and distribution practices and processes that are restorative to nature.
- Transparency, reflecting our desire to empower and inform purchasing through honest relationships between consumers and corporations.
- Accessibility, enabling broader consumer access to organic and natural food, products and services as part of our commitment to the health and wellness of all individuals, communities and cultures.
- Traceability, holding suppliers, manufacturers and distributors accountable for a clearly defined, quality-controlled productions process that ensures products are accurately labeled, undergo appropriate testing and reflect consumers’ desire for wholesome goods and services.
When the New York State Attorney General announced his investigation into the quality of herbal supplements on the shelves at some of the nation’s largest retailers, Organic & Natural took action, requesting a meeting with the Attorney General’s staff and proposing what we feel is a viable solution for improving the quality of dietary supplements.
As noted in the Attorney Genera’s press release, “ just 21 percent of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels — with 79 percent coming up empty for DNA related to the labeled content or verifying contamination with other plant material." It is our position that requiring manufacturers of raw ingredients to adhere to FDA’s existing cGMPS will improve the traceability of ingredients and provide the transparency required to ensure quality and safety and enable consumer confidence in the authenticity and purity of the products they are purchasing.
To that end, we have submitted a Citizen Petition to the FDA. Applying the FDA’s current cGMPs (code 21 CFR Part 111) to raw material manufacturers will ensure supply chain integrity is managed at the earliest possible point. This will necessitate manufacturers of raw ingredients have a strong working relationship with farmers and that appropriate cGMPs are instituted at the point where raw materials are manufactured. Doing so will provide flexibility and be welcomed by branded ingredient manufacturers that are already following cGMPs, but are forced to compete with lower quality ingredient manufactures that have minimal, if any, cGMPs. The petition will also request FDA to clarify the obligations of private-label distributors under 21 CFR Part 111, as there is significant confusion to their responsibility evidenced in the warning letters issued by FDA.
Our approach is to collaborate with the Attorneys General, sharing our viewpoints and discussing items where we can both agree and agree to disagree. Organic & Natural will not support a reliance on the use of testing alone to evaluate products. We expressed our grave concerns relating to DNA bar code testing of herbal extracts, and the more general prospect of dictating testing standards for dietary supplements. Appropriate, scientifically validated testing is a critical component of supply chain integrity, but it is only one component, and it is only as good as the day a test is administered. The ability to ensure 100 percent surety through testing would require testing of every lot and batch of final product. This issue demands the implementation of a complete solution set so that all elements of product integrity are monitored, including testing for potential contamination, adulteration and identity.
In order to proactively address the continual criticism directed toward the supplement industry about lack of regulation and the inability to police ourselves, we must address the fact there are bad actors supplying the public with inferior products. Improving supply chain integrity may not solve all the issues, but it is a significant, transparent step towards progress. Organic & Natural will do all it can to establish integrity in the manufacturing process, instill clarity in the use of well research health care claims, and provide education on what constitutes quality and effectiveness of these products. With these steps, we believe consumers will no longer be required to differentiate between high-quality and low-quality products.
More on Organic & Natural at www.organicandnatural.org follow on Twitter @OrgNatHealth or www.facebook.com/organicandnaturalhealthassociation. WF
Karen Howard, CEO and Executive Director of Organic & Natural Health Association, is a visionary and results-focused leader who has spent more than 30 years working with Congress, state legislatures and healthcare organizations to develop innovative healthcare policy and programs. She has held a variety of executive positions, including serving as professional staff for a Congressional committee, and has policy expertise in the diverse areas of integrative and complementary medicine, managed care, healthcare technology and mental health. An advocate at heart, she has worked to strategically advance the mission and vision of organizations through effective advocacy and strong collaboration.
Posted May 12, 2015