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FDA Proposes to Revoke Authorized Health Claim for Soy Protein

The U.S. Food and Drug Administration (FDA) recently proposed to revoke an authorized health claim regarding the relationship between soy protein and decreased risk of coronary heart disease (CHD). According to a statement from Dr. Susan Mayne, FDA drafted this proposal after observing inconsistencies in published scientific data surrounding the claim.

Why is FDA changing the status of this claim?

FDA authorizes a petitioned health claim by examining the “totality of scientific evidence” surrounding the relationship between a specified substance and a disease (e.g. fruits and vegetables and the reduced risk of certain cancers).  Publically available data must demonstrate “significant scientific agreement” (SSA) among qualified experts for FDA to authorize the claim.

In the case of soy protein and CHD, Mayne states that “the totality of currently available scientific evidence calls into question the certainty of this relationship.”  Studies conducted following the claim’s authorization in 1999 yielded inconsistent findings between the two and helped influence FDA’s decision to issue the proposed rule.

What does this mean for my food labeling?

Substance/disease relationships that do not meet the standard of SSA may become qualified health claims through petitions to FDA that provide credible scientific support. Such claims require a disclaimer or other qualifying language on a product’s labeling that convey the level of scientific support for the relationship. Examples of qualified health claims include:

  • “Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.”
  • “Although the evidence is not conclusive, tomato products, which contain lycopene, may reduce the risk of prostate cancer.”
  • “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

Should FDA finalize this rule and a petition for the soy protein and CHD relationship provide sufficient scientific support, the Agency may consider it a qualified health claim. FDA issues Letters of Enforcement Discretion that outline specific language, similar to the examples above, for making qualified health claims on a product’s label.  Food manufacturers who previously displayed the authorized claim may need to adjust their labeling to reflect potential changes.

While this proposed rule does not enact certain or immediate changes, food manufacturers should be conscious of health claims on their labeling, especially when updating to comply with FDA’s new label rules. Labels presenting claims that are not authorized or qualified are considered misbranded.  Marketing a misbranded food product in the United States is a prohibited act that may be met with Warning Letters, detentions, or other enforcement actions.

An examination of your labeling by a third party experienced in FDA regulations can be an invaluable business decision. Registrar Corp’s Regulatory Specialists can conduct a full review of your product’s labeling.  In addition to a detailed report of recommended revisions, you will receive a print-ready file of your revised label.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.





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