Home » Articles » Regulatory Issues

Voices: Regulatory Issues

Some health claims in jeopardy

FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer.

FoodProcessing.com
By David Joy

The FDA recently announced its intention to re-evaluate certain authorized health claims in light of new scientific evidence that either supports or calls into question the health claims. This is the first time FDA has reassessed the scientific evidence supporting health claims since the current regulatory regime governing health claims went into effect.

A health claim is a claim about the relationship between a substance in the diet and a disease or health-related condition. They are generally worded along the lines of  “a diet rich in substance X may reduce the risk of disease Y.”

Health claims must be cleared by FDA before they are used to promote food or dietary supplement products. There are currently three paths available for the authorization of a health claim:

• A petition showing that the “significant scientific agreement” standard of the Nutrition Labeling and Education Act is satisfied can result in a traditional, unqualified health claim;
• In cases where FDA believes the “significant scientific agreement” standard is not met, a qualified health claim may be authorized;
• A manufacturer may notify FDA that it intends to make a health claim based on an authoritative statement from a federal scientific agency, as provided for under the Food and Drug Administration Modernization Act.

FDA has not announced plans to tamper with this basic regulatory framework, but intends to re-examine the following specific claims.

1. Soy protein and a reduced risk of coronary heart disease

In July 2005, the Agency for Healthcare and Research Quality (AHRQ) issued a report titled Soy, Effects on Health Outcomes. FDA notes the conclusion that soy products appear to exert a small benefit on low-density lipoprotein cholesterol. However, it was not clear, either to FDA or in the report, whether soy protein or other soy components were responsible for any effect. FDA has concluded that the AHRQ report raises questions regarding the strength of significant scientific agreement supporting this particular health claim.

2. Dietary fat and cancer

In 2005, the Institute of Medicine (IOM) issued a report titled Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids, which suggested that the association between diets high in fat and increased cancer risk has been weakened by recent epidemiological studies. IOM concluded that the evidence linking consumption of fat with increased cancer risk was not sufficient to consider cancer as a disease outcome in setting an acceptable macronutrient distribution range for total fat.

3. Antioxidant vitamins E and C and selenium, and certain cancers

This re-evaluation appears to be based on a May 2006 report by AHRQ, titled Multivitamin/Mineral Supplements, Chronic Disease Prevention. The report did not identify any studies on the efficacy of vitamin C supplements and cancer risk, but concluded that the overall strength of the evidence is low for vitamin E and selenium.

FDA intends to review the current scientific literature to determine if evidence continues to support the permitted qualified health claims or whether the language of the health claims should be modified to reflect a stronger or weaker relationship.

4. Cancer health claims by cancer site

FDA also is re-evaluating its position on whether cancer-related health claims for dietary fat (authorized) and antioxidants and selenium (qualified), which currently must refer to “certain forms of cancer,” may specifically identify sites affected by cancers. FDA has already considered separate qualified health claims for each type of cancer for some other substances, e.g., tomatoes and prostate, ovarian, gastric and pancreatic cancers; green tea and prostate and breast cancer; and calcium and colon/rectal, breast and prostate cancers and recurrent polyps. FDA notes that the most current scientific evidence indicates the etiology, risk factors, diagnosis and treatments are unique for each type of cancer.

FDA’s desire to re-evaluate these claims is sensible and comes at a time when health claims and particularly qualified health claims are often attacked as misleading by consumer advocates.

Scientific knowledge regarding diet and health is constantly evolving. This obviously creates both challenges and opportunities for the food industry, as manufacturers scramble to keep up with the latest information and then hope it remains current long enough to realize a return on investments in new formulations and claims.

David Joy is a partner in the Washington DC office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.

---

More Voices

Some health claims in jeopardy
02/15/2008
FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer.

Regulatory Issues: New rules on reporting contamination
11/16/2007
Manufacturers will not have the option of handing recalls quietly. Information may even appear on FDA’s web site.

Regulatory Issues: Navigating the health claim maze
09/04/2007
FDA’s recent guidance focuses only on the process for evaluating evidence supporting a health claim.

Regulatory Issues: Aspartame gets scrutinized again
08/08/2007
The sweetener is the most scrutinized food additive present in the diet. Regulatory bodies around the world have agreed many times on its safety.

Regulatory Issues: Labeling reconsidered for irradiated foods
06/18/2007
Irradiation may not eliminate food poisoning, but it would be a big step in the right direction.

Regulatory Issues: Atkins put to the test
05/07/2007
Nutrition is complicated. It’s not a bad thing to question the science underlying conventional wisdom.

Wellness Foods' Regulatory Issues: It’s a Natural
04/03/2007
A “natural” claim for foods is still subject to uncertainty over standards.

Regulatory Issues: Trans fat tipping point
03/05/2007
For better or for worse, there seems to be no real, ongoing scientific debate about whether trans fats are truly dangerous.

Regulatory Issues: Food Allergen Update
02/07/2007
At the end of 2006, FDA issued Edition 4 of its Food Allergen Guidance for Industry.

Regulatory Issues: Democrats eye regulatory changes
02/01/2007
We may see the creation of a Food Safety Administration, taking all food safety activities from FDA, USDA and EPA.

Regulatory Issues: FDA considers functional foods
01/09/2007
Existing requirements for functional foods meet a very high standard; any additional requirements would exceed FDA’s statutory authority.

Regulatory Issues: A tiny bit of regulation
10/23/2006
In addition to questions about how FDA will address food nanotechnology is the question of consumer acceptance. Hopefully, we will not see a repeat of the war against genetically modified foods.

Regulatory Issues: Regulatory Roundup
09/28/2006
As the legislative year grinds to a halt, here’s what’s left – and what will be on the table when things pick up again.

Regulatory Issues: FDA reports on allergen contamination
09/27/2006
If the food industry continues to show awareness of the dangers of food allergens, FDA and Congress likely will continue with a measured and deliberative approach.

Regulatory Issues: Guard against intentional contamination
09/06/2006
The food industry is fortunate Congress and FDA have not developed more specific requirements for food security.

Regulatory Issues: Food Safety Warnings
09/06/2006
Two developments regarding the preemption of state food safety warnings the food industry should know.

Regulatory Issues: Opportunities and challenges of functional ingredients
08/07/2006
Common use in dietary supplements simply does not go far toward establishing GRAS status for a functional ingredient’s use in conventional foods.

Regulatory Issues: EU rules on health claims take a step forward
06/30/2006
Ten years in the works, the European Parliament’s review of health and nutrition claims on food labels may end a longstanding prohibition against claims relating to human diseases.

Regulatory Issues: Self-Regulation of Advertising to Children
06/29/2006
Emotions run high when it comes to advertising to kids, but processors have an alphabet soup of tools for enacting voluntary regulations.

Regulatory Issues: Trade lawyers descend on Codex
06/01/2006
No longer the province of food scientists, Codex meetings and standards play a role in the resolution of trade disputes.

Regulatory Issues: FDA may cut food-contact program
05/21/2006
The agency’s proposed budget may mean an end to the efficient and speedy Food Contact Notification Program … and two- to five-year waits for reviews.

Regulatory Issues: Marketing Products Using the Dietary Guidelines
04/04/2006
Companies must ensure that any marketing use of the guidelines is truthful and not misleading within the total context.

Questionable new tactics from the Food Police
03/29/2006
The Center for Science in the Public Interest assumes incorrectly there is no room in a healthy diet for enjoyable foods.

Regulatory Issues: FDA Denies Petition on Whole Grain Descriptors
02/23/2006
Currently, hundreds of products are marketed with “whole grain” statements, despite ambiguity concerning the regulatory status of descriptors such as “good” and “excellent” source.

Regulatory Issues: Modernization of food GMPs
01/31/2006
Most of the modernization opportunities involve written documentation or recordkeeping, suggesting FDA wants to enforce the food GMP regulations efficiently.

Regulatory Issues: Bioterrorism recordkeeping essentials
12/19/2005
This month, FDA expects food companies to start “one-up, one-down” recordkeeping.

Regulatory Issues: Natural acrylamide in food faces FDA scrutiny
12/06/2005
Are warnings for acrylamide in foods informative, premature or preempted?

Regulatory Issues: FDA Accepts Use of Existing Labels
11/01/2005
The FDA has agreed to accept requests by processors to use existing labels after the trans fat labeling effective date.

Regulatory Issues: A proposed rule is not a final rule
09/23/2005
FDA recently confirmed its reversal on “and/or” wording in ingredient statements.

Synthetic Organics Out
09/01/2005
As a result of a recent federal court decision, the use of synthetic substances in processed organic products will be restricted in the future.

Regulatory Issues: Uncertainty of allergen thresholds
08/29/2005
Unfortunately, science does not allow us to know with certainty that a particular allergenic protein will not cause a single reaction in the entire population of sensitive individuals at a given level of exposure.

Regulatory Issues: Progress on health claims in Europe
06/28/2005
Proposals look similar to what we have in the U.S; differences reflect a greater degree of skepticism toward health claims in Europe.

Regulatory Issues: What’s in a name?
06/27/2005
FDA and USDA propose new principles for food standards of identity.

Regulatory Issues: Serving up whole grains
04/04/2005
With consumers increasingly aware of the benefits of whole grains, a simple, factual statement about their presence is enough.

Regulatory Issues: Obesity Report In, Allergens Out
03/01/2005
The Obesity Working Group Report confirms calories are what count when it comes to healthy eating.

Regulatory Issues: The FDA agenda for 2005
12/28/2004
It’s not good when FDA’s scientists are demoralized and the agency stands accused of being too friendly with a regulated industry.

Regulatory Issues: COOL rules finally issued
10/07/2004
The country of origin law applies only to commodities, not processed foods.

Regulatory Issues: FDA weighs labeling changes
05/30/2004
One issue is if food packages that can be reasonably consumed at one time need to declare the whole package as a single serving.

Regulatory Issues: E.U. issues new GMO regulations
12/15/2003
The new rules may represent a step forward -- and the most that any proponent of genetically modified foods can realistically hope for

Regulatory Issues: COOL reception for country-of-origin labeling
11/15/2003
Retailers may ask suppliers to guarantee the information is correct and/or indemnify the retailer in the event of an enforcement action

Regulatory Issues: Science and food safety
07/15/2003
NAS criteria pinpoint dangers and may prompt new legislative authority for feds

Regulatory Issues: Security, safety and efficiency
05/15/2003
Two years ago, no one could have predicted that food security would so dominate FDA's priorities for 2003 and beyond