Dietary Supplements

FDA considers alternatives for regulating qualified health claims

The US Food and Drug Administration (FDA) is currently considering the way in which it regulates qualified health claims for foods and dietary supplements, and is reviewing comments submitted by interested parties during a consultation on appropriate alternatives to the current system (see Table 1 for explanation of qualified health claims)^1,2. The new system will either replace or codify an interim system for regulating these claims, which was implemented in July 2003 as part of the FDA Consumer Health Information for Better Nutrition initiative launched six months earlier. The initiative is intended to improve the provision of information on dietary supplements and increase enforcement activities to prevent misleading claims^3,4. Under the same initiative, the FDA established a task force to make recommendations on the regulation of health claims for food and dietary supplements⁵. These recommendations formed the basis of the FDA's consultation which ended on 25 February 2004.

Options for regulating health claims

The FDA is considering three options developed by the health claim task force. These are outlined below:

Option 1: Codify the current interim procedures and evidence-based ranking system (or variation of these) into a regulation

This option would maintain the pre-market clearance system that provides for FDA review of claims and supporting data, and allows for public comment on the claims, although not through a notice-and-comment rulemaking process⁶. Claims would remain in the form of an enforcement discretion letter and not a regulation. The FDA notes that:

• it allows claims to be made in a timely manner - FDA review would be required within 270 days of application as opposed to the allowed 540 days for the notice-and-comment rulemaking process;
• it would allow claim decisions to be revised more easily in response to subsequent data; and
• it would provide for the use of disclaimers where they may cure potentially misleading health claims.

Option 2: Reinterpret the significant scientific agreement (SSA) standard (see Table 1), to apply to the accuracy of evidence for the claim, rather than the underlying disease/substance relationship, and introduce a notice-and-comment rulemaking procedure for qualified health claims

This option is consistent with suggestions made during FDA consultation on the 2002 guidance for industry on qualified health claims⁷. Under this option the FDA would focus on whether the words of the claim accurately reflect the supporting data, rather than whether there is significant scientific agreement supporting the substance-disease relationship. Claims would be maintained in a regulation and subject to a notice-and-comment rulemaking process. The FDA notes that:

• reinterpretation of the SSA standard could eliminate the value of the standard because claims about any substance-disease relationship, no matter how weak or preliminary the evidence, would meet the SSA as long as they accurately described the level of evidence;
• it is a more time-consuming option due to the requirement for notice-and-comment rulemaking process;
• it may not provide sufficient flexibility to implement changes to the claims necessitated by rapid developments in science; and
• it is open to legal challenge of unconstitutionality as the value of commercial speech often depends on its timeliness.

Option 3: Regulate qualified health claims on a post-market basis

Under this option the FDA could only evaluate and, where necessary, prohibit a claim after it appears on a product label. This would require the FDA to build an enforcement case by searching literature and consulting with experts, and possibly testing how consumers would interpret the claim. This is because the FDA does not have the administrative subpoena power to obtain a company's substantiating data, evaluate the data and, where appropriate, take enforcement action with relative speed. The FDA would not review or clear claims before they appeared in labelling and there would be no opportunity for public comment. The FDA notes that:

• it could be inefficient and too resource-intensive for the FDA to be able to protect consumers from misleading claims that would already be in the labelling of products in the marketplace; and
• the procedure for challenging a health claim under this option would be difficult.

Other issues under consideration

Other issues that were raised in the FDA task force report, and which the FDA is considering, are as follows:

Data and research in a substance/disease relationship for significant scientific agreement (SSA)

The FDA is considering how to provide incentives for manufacturers to develop the data needed to obtain significant scientific agreement for unqualified health claims (see Table 1).

Revised claim language for unqualified health claims

On the advice of the task force, the FDA is considering removing the requirement for the word may to be used in health claims (e.g. calcium may reduce the risk of osteoporosis) to eliminate any uncertainty that may be, or often is, caused about the science underlying claims that meet the SSA standard.

Interim final rules for unqualified health claims

The FDA is considering whether to authorise unqualified health claims through interim final rules to expedite the availability of the health claim in labelling. This would speed up the availability of this information to consumers while retaining the public comment period. It should be noted, however, that although comments help the FDA to more accurately articulate the science and to better define the substance, they have never been used as the basis for the rejection of a health claim.

Use of phrases such as ‘FDA authorised’ in qualified and unqualified health claims

The FDA is considering whether the use of a phrase indicating FDA authorisation would be appropriate on foods and dietary supplements, and it would encourage consumers to have more confidence in a claim it accompanied than in a claim without the phrase. Currently the FDA discourages or prohibits use of such phrases, as all products of that type are FDA approved, therefore a label statement on one product would imply a difference that does not exist. In addition, the FDA does not approve any individual product.

Consumer education

The FDA is looking into how to best educate consumers about the role for qualified health claims and how such claims may be used by consumers to advance their own understanding of diet and health matters.

Evaluations of outside scientific groups

The FDA is considering whether or not to accept the evaluations of outside scientific groups, either specifically convened groups of experts or existing organisations such as the American Heart Association, as representing scientific consensus that could justify health claims. In making this decision the FDA must consider whether it can place confidence in the groups’ conclusions, given the fact that some groups would have more expertise than others and the FDA is not aware of a mechanism for evaluating them fairly and accurately.

Competent and reliable evidence

Finally, the FDA is also looking into the meaning and relevance of ‘competent and reliable scientific evidence’ for the purposes of supporting a qualified health claim, following a recommendation made by the task force that the FDA should only consider this type of information, which the FTC defines as: ‘tests, analyses, research, studies or other evidence’ based upon the expertise of professionals in the relevant area that has been ‘conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted’ in the profession to ‘yield accurate and reliable results’.

Table 1. Types of claims that can be made on dietary supplements, US

Unqualified health claims

These are health claims that characterise a relationship between a dietary supplement and the risk of a disease, and require FDA authorisation. The FDA authorises these health claims based on an extensive review of the scientific literature, generally as a result of the submission of a health claim petition, using the significant scientific agreement (SSA) standard to determine that the nutrient/disease relationship is well established.

 

Qualified health claims

These claims are used when there is emerging evidence for a relationship between a dietary supplement and reduced risk of a disease or health condition, but the evidence is not well enough established to meet the significant scientific agreement standard. Qualifying language is used as part of the claim to indicate that the evidence supporting the claim is limited.

 

Structure/function claims

Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, ‘calcium builds strong bones’. In addition, they may characterise the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, ‘antioxidants maintain cell integrity’, or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also describes how widespread such a disease is in the US. On dietary supplement labels these claims must state in a ‘disclaimer’ that the FDA has not evaluated the claim, and that the dietary supplement product is not intended to ‘diagnose, treat, cure or prevent any disease’. Manufacturers of dietary supplements must submit a notification to the FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.

 

References

1. Federal Register, 27 January 2004, 69(17), 3868

2. Federal Register, 25 November 2003, 68(227), 66040-66048

3. The Regulatory Affairs Journal - Pharma, 2003, 14(4), 322-325

4. FDA News, P03-54, 10 July 2003, www.fda.gov

5. Federal Register, 11 July 2003, 68(133), 41387-41390

6. Ibid

7. The Regulatory Affairs Journal - Pharma, 2003, 14(4), 322-325