But this year is even more of a time for reflection as CRN prepares to celebrate its golden anniversary in 2023. Are we living up to the mission and legacy established 50 years ago when three vitamin companies formed the Council for Responsible Nutrition in response to FDA’s publication of a final rule establishing a Standard of Identity for vitamin and mineral supplements. FDA proposed to limit the amounts and combinations of vitamins and minerals that could be marketed without a prescription. Needless to say, the fledging industry did not take the news well, and the opposition, led by CRN, eventually led to the Proxmire Amendment which required FDA to demonstrate that the serving level of a vitamin or mineral is unsafe to remove it from the market.
According to Annette Dickinson, CRN’s first full-time employee, CRN’s goal was to establish a moderate, rational, scientifically based voice on dietary supplement issues at a time when most organizations speaking on the subject tended to be somewhat extreme. CRN took a moderate view --the organization would be led by science, data and facts. If this nascent industry was to thrive, some government guardrails had to be established, but that framework also had to accommodate wide access to the products and innovation for product development. Right from the start, “responsible” was front and center in the mission and approach. So, it became CRN’s middle name.
Responsible is a moniker we don’t take lightly at CRN. “Responsible” is defined as “capable of being trusted; morally accountable for one's behavior; having an obligation to do something, or having control over or care for someone.” During the past year, we have strived to live all aspects of that definition--worthy of trust, accountable, and stewards for the industry and our consumers.
This past year, the most notable example has been CRN’s unwavering commitment to create a dietary supplement registry. At this writing, the outcome is uncertain, but our motives have been transparent from the start. Quality-focused companies consistently complain that FDA isn’t doing enough to enforce the law or to maintain a fair and level playing field for conscientious marketers—yet FDA can’t effectively oversee an industry if it can’t see the four corners of the market. FDA’s Cara Welch stated it succinctly when she spoke to CRN’s Board recently saying, “It’s ridiculous that we don’t know the size of the market we are regulating.” Mandatory listing solves that dilemma.
Being responsible has meant providing the facts and being honest in our lobbying. While some industry groups have falsely claimed that dietary supplement listing is a form of pre-market approval, the facts demonstrate otherwise. To counter this misinformation campaign, CRN even requested and obtained the insertion of language stating “Nothing in this section shall be construed … to grant the Secretary authority to require the approval of a dietary supplement prior to marketing.” Controversy resolved. Regardless of the outcome, CRN will continue to promote a transparent market where regulators and consumers can get information about the supplements being sold and hold manufacturers accountable for their products and labels.
Being responsible means holding others accountable too. Earlier this year, CRN called out FDA for its consumer education programs for supplements that overemphasize supposed risks over benefits and dwell on ways supplements are not regulated as drugs are, rather than all the ways FDA does regulate them. We have challenged mainstream media when they misreport the outcomes of clinical research, achieving retractions and corrections, or inserting an industry perspective into otherwise one-sided coverage of supplements.
Being responsible doesn’t mean being a pushover, and that resolve has been on display this year with CRN’s response to states seeking to impose age restrictions on certain supplements. As with all our policy stances, the position began with a review of the science. Proponents of age limits on weight management and sports nutrition products allege these products are associated with development of eating disorders, but the science just doesn’t support these claims. Then, CRN commissioned a safety review of six of the most popular ingredients in these products, and again, the evidence failed to demonstrate any significant concerns. Science should dictate the outcome, and CRN will defend the right for consumers to access these products.
This year, FDA weaponized the drug preclusion provision of DSHEA to protect pharmaceutical interests—that has tested what responsible firms should do too. CRN determined quickly that the invocation of drug preclusion was about more than a single ingredient, like NAC, but would have implications for innovation across the industry. We were right, as FDA has invoked drug preclusion with regard to NMN and several other ingredients. Industry will need to recognize that FDA’s actions here will have an impact, and must join in resisting this reinterpretation of the law. FDA must not be allowed to grant Pharma broad monopolies over dietary ingredients.
“Responsible” requires acting with restraint and self-regulation too, and that was on display this year as CRN’s board of directors adopted a new voluntary program regarding labeling of proprietary blends, and endorsed the BAPP program on destruction of irrevocably adulterated ingredients. Next up is a possible best practices guideline for labeling ingredients that are inextricably combined with other ingredients. These are not easy exercises, but they are critical to reinforcing the consumer trust being built for products promoted for health and wellness.
So, as I look ahead to CRN’s 50th anniversary, I’m buoyant on our future. No other organization so strenuously fights for its members and the future of the industry. Throughout the year, we will be highlighting milestones and accomplishments from our first 50 years. Through all these challenges, we never forget “responsible” is our middle name.
