Collaboration, Industry Regulatory Bodies

Industry and Regulatory Bodies Collaborate with Adversarial Respect

Careful word choice for industry interaction with regulatory agencies reflects relationship, defines approaches to be used and insists on respect.

Collaboration: noun:

  1. The action of working with someone to produce or create something.
  2. Traitorous cooperation with an enemy.

Source: Oxford American College Dictionary

Words have meaning. More importantly, words transfer their meaning into actions, and establish the bounds and limits for those actions. They also establish relationships between people, organizations, business entities and industries. These words must be carefully chosen, since their application may be critical to the outcome of any interchange of words between the parties involved.

Collaboration is a critical word when discussing the relationship between any industry and the government agencies involved in regulating that industry. Collaboration once had an exclusively negative connotation, with the second definition (see above) applied with greater frequency. Today, discussions through the industry apply the term as a foundation for relating with the regulatory agencies governing industry. Obviously, the meaning of the word recently is interpreted in a more positive light. Modern dictionaries relegate the negative definition of the word to secondary application, but the definition remains and should be remembered.

The choice of words used in discussing health and nutrition industry approaches in today’s regulatory environment is essential to long-term, regulatory outcomes. While evidence shows the current governmental environment is more in favor of business and minimally interested in developing and/or enforcing regulations, the fundamental perspectives of the regulatory agencies involved remains unchanged. Simultaneously, the perspective of a large percentage of the industry is one that ranges from choosing to ignore current requirements to applying only the loosest compliance attempts while challenging the regulatory agencies to act.

The relationship between any industry and regulatory agencies responsible for that industry must be one of respectful adversaries. The parties establish respect while simultaneously recognizing the relationship as adversarial. This falls far short of collaboration, regardless of the definition chosen. The concept of working with regulatory agencies in a collaborative effort stops with the recognition of the adversarial nature of the relationship.

The development of respect is an earned result of dialog as well as discussion without unnecessary intransigence; but, this is not dependent on automatic or even routine concession. The industry needs to recognize the nature of the commitments required for the relationship, while remaining forthright in the consensus positions of the industry.

Discussion of topics and matters between parties must not consist of concession to the adversary from the outset. This is recognized by regulatory agencies as cooperation occurs daily with the compliant operation, marketing, production and sale of products. No additional requirements need to be fulfilled.

Recognition of the adversarial nature of the relationship does not mean scoff-law approaches to existing regulations. Misunderstanding of the relationship results in immense challenges. Discussion of issues and resolution of conflicts results from maintaining relationship recognition and working with, just short of collaboration, the adversary. That work is challenging but necessary to ensure continued health of the industry as well as continued delivery of safe, meaningful products to the population. These discussions begin with coming to an understanding of the most critical terms’ definitions. Acceding to terms, outlines of approach or even published draft guidance is not evidence of a respectfully adversarial discussion. Each of these discussions must build upon previous determinations, ideally based on consensus of both parties in a respectful fashion.

Everyone in the industry has a requirement to fulfill their role in maintaining the respectful, adversarial relationship. Industry members must comply with applicable regulations for activities they perform in their workplace. Industry leaders must approach regulatory discussions respectfully and completely, but with firm recognition of the adversarial nature of the relationship. These efforts include a greater understanding of the definition of terms, regardless of their application.

Resistance to efforts or initiatives should not be construed as being uncooperative. This approach is far from any definition of collaboration, but is the approach that fits the regulatory scheme the country has long established. The application of the two key words “respect” and “adversary” offers a vastly superior approach to all regulatory matters when compared to collaboration.

As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity (ingredientidentity.com). He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.

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