Inconsistent messaging? CRN critiques FDA’s portrayal of supplement and cosmetic safety
20 Sep 2022 --- Following the release of the US Food and Drug Administration’s (FDA) Supplement Your Knowledge content, the Council for Responsible Nutrition (CRN) is expressing concerns over how dietary supplements are presented, particularly in the contrasting language and tone used, compared to cosmetic ingredients.
“CRN hopes that by sharing this feedback with FDA, we put the agency on notice that dietary supplement stakeholders, such as our responsible member companies, have seen this content and won’t allow negative bias to stand,” Gretchen Powers, VP for marketing and member experience at CRN, tells NutritionInsight.
“This feedback is just one part of CRN’s long-term, ongoing effort to engage the FDA and be an active participant in the regulatory process. CRN regularly comments to the agency on technical matters in proposed regulations. For example, CRN petitioned FDA on NAC (n-acetyl cysteine) and CBD and has commented every step of the way on New Dietary Ingredient (NDI) notifications.”
Meanwhile, Powers explains that CRN is not going to speculate on the impacts of its comments on the cosmetics industry.
“We only referenced cosmetics as a basis for comparison to delineate the stark contrast in how FDA communicates how it regulates both industries to the public. While the regulatory methodology is virtually similar, the tone and language used to communicate that authority is diametrically opposite.”
Improvements to FDA’s content
The suggestions by CRN focus on how the FDA content downplays the benefits of taking supplements while exaggerating the potential hazards. It overlooks opportunities for responsible supplement use to address public health problems, the council argues.
According to CRN’s commentary, the FDA provides the impression that the regulation is insufficient because it does not explain the regulatory framework that has been put in place to give the agency control over dietary supplements.
“We strongly believe the content, in its current form, portrays supplements inappropriately by overemphasizing and overstating the risks and fails to accurately express the benefits supplements can play toward maintaining one’s overall health,” says Powers, regarding the impact the CRN commentary could have on the nutrition industry.
“However, we appreciate and applaud FDA’s desire to communicate information on nutritional supplements to the public and stakeholders.”
Additionally, future messaging could be improved by cooperation with the dietary supplement sector through CRN, the organization adds.
Missed opportunities: Addressing health
One of the most recurrent topics identified by CRN is an exaggeration of the potential risks of supplement use and insufficient inclusion of well-established health benefits.
This distorted presentation results in missed opportunities to address public health issues that could be improved with supplementation, such as nutrient deficiencies, supplement usage for specialty populations, supplements that can counteract nutrient depletion from prescription medication and supplements that have been shown to lower the risk of certain diseases.
The FDA’s “Cosmetics Product” page states that cosmetic ingredients and products are not required to have FDA approval before being sold in the US. The only exception is color additives, which need to be certified for their intended purpose – apart from the coloring components used in coal-tar hair colors.
Companies and people that sell cosmetics have a legal obligation to ensure the safety of their products. “In order to take action for safety reasons against a cosmetic on the market, we need reliable information showing that it is unsafe when consumers use it according to the directions in the labeling or in the customary or expected way,” the FDA’s page details.
Powers adds: “Our recent letter on FDA’s communications is ‘unique’ in that the agency did not publicly solicit the comments. CRN and its members found the educational content so problematic, and the process behind its development so non-transparent, that we felt it was our duty to push back.”
Contrast with cosmetics regulations
What CRN views as a one-sided presentation starkly contrasts with how the agency speaks about other categories it regulates, such as cosmetics and medical devices.
Similar to supplements, cosmetics are not FDA-approved before being sold. This fact, nevertheless, is expressed in a very different way than supplements.
CRN details that according to the FDA’s website, cosmetics do not “require” clearance and there are no big, apparent danger signs about their safety. However, pre-market approval is not required for supplements due to a lack of legal authority.
The FDA “inappropriately links” this regulatory constraint with concerns about effectiveness and safety, the council warns.
“It’s slow going, but we hope the agency will make revisions or develop balanced content that presents dietary supplements more fairly in a manner that is more useful to consumers making decisions about their health and wellness,” Powers concludes.
By Nicole Kerr
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