Some marketers attempting to capitalize on the latest influenza outbreak are veering into product claims territory that risks drawing warning letters or other enforcement from FDA.

Bridgeport, Conn.-based vitamin and dietary supplement marketer VitalMax Vitamins referred to the flu in a Jan. 16 marketing release, promoting its BodyGuard product as “a powerful ally in the current flu epidemic” that “offers ultimate wellness protection.” However, the firm withdrew its claims after a request for an interview on those claims.

Boca Raton, Fla.-based Flu and Cold Defense LLC stands by claims it makes for GermBullet botanical formula inhaler. A spokesman said lab tests back statements made in a Jan. 15 release that link the product to resisting viruses.

Food and drug attorney Ivan Wasserman said for supplement firms, the safest claim is not to say anything about the flu, but “supports immune system” is a standard claim that more likely will be safe. Even the language “boosts immunity” would need substantiation under FDA policy, notes Wasserman, a partner in the Washington office of Manatt, Phelps & Phillips.

Trade groups see flu claims for products marketed as supplements as a red flag for other problems. The claims could be a sign that a firm does not know the regulatory framework the Dietary Supplement Health and Education Act imposes.

“If they don’t know the basics of claims, well, do they know about adverse event reporting requirements, GMP standards, child safety caps for iron?” said Duffy MacKay, the Council for Responsible Nutrition’s VP of science and regulatory affairs.

“If they’re making these claims, they’re probably not following other aspects of the law. You can’t trust anything that they’re saying,” said Cara Welch, the Natural Products Association’s VP of science and regulatory affairs.

Flu Claims: Warning Territory

The Centers for Disease Control and Prevention said Jan. 5 the flu season started early in the U.S., with most of the country experiencing high frequency of influenza-like symptoms. CDC said Jan. 18 the prevalence of flu reached epidemic level as 8.3% of all deaths reported from the 122 cities in the agency’s mortality reporting system were due to pneumonia and/or the flu for the week ending Jan. 12. The threshold for an epidemic is 7.3% of all deaths.

The agency said 48 states reported widespread flu activity. CDC added that 129.4 million doses of vaccine had been used and 145 million doses were produced for the U.S. for the 2012-2013 flu season.

The only approved prevention for a flu virus is vaccination, and FDA historically has seen supplements with marketing materials mentioning the flu, or even using imagery of cold or flu, as crossing into disease claim territory.

Welch pointed out unsubstantiated claims might lead consumers to think a product will help prevent or even treat the flu and convince them they do not need a flu vaccination. “It’s dangerous to give people hope that these products that are making these claims can help you with the flu,” she said.

VitalMax included in its release a statement by the firm’s medical expert, Mark Rosenberg, a physician. BodyGuard “guards against a variety of bacteria, germs and viruses that, in this epidemic flu season, can be a real benefit to staying healthy … and an array of herbal nutrients used for centuries to support the respiratory system,” Rosenberg said in the release.

A day after an inquiry from “The Tan Sheet” about the claims, a spokeswoman for VitalMax said the firm was withdrawing the press release, noting BodyGuard “is not intended for the treatment or cure of the flu.”

Flu and Cold Defense says GermBullet contains a proprietary blend of 11 essential oils. The product launched in the 1980s in liquid format and recently became available in an inhaler, according to the firm’s website.

The firm’s release points out states have “reported widespread geographic influenza activity” and that CDC said “the proportion of deaths attributed to pneumonia and influenza was slightly above the epidemic threshold.”

The release adds that GermBullet can be used to “reduce the number of viruses so that your immune system is not overwhelmed especially in crowded environments and airplanes.”

The product’s website states that an “FDA recognized virology lab independently tested GermBullet inhalation blend and confirmed that it has the potential capability to kill cold and flu virus” and that laboratory testing confirmed the product “has a broad spectrum potential capability to kill illness-causing bacteria, mold, and fungi.”

A spokesman for the firm said GermBullet is a natural product and no health or disease claims are being made. “It was tested in the labs, and there have been different studies on it that it reduces cold and flu germs,” he said.

MacKay noted that a firm needs numerous clinical trials to make such claims in any format. The only research identified on the product website is for an in vitro study of the effects of GermBullet.

Wasserman said an inhaled non-pharma product such as GermBullet typically can make “feel-good claims,” but when claims run into therapeutic territory, FDA would “consider it to be a drug.”

He noted a press release might not generate the same level of FDA interest as packaging or labeling statements. However, when a release promotes sales of a product, “certainly, yes” FDA would take it into consideration as marketing, Wasserman said.

Homeopathics Enter Fray

Homeopathics using the world “flu” in the product name could also raise alarm for FDA, such as STS Laboratories’ FluNada throat andnasal sprays, which contain elderberry, eucalyptus and mint.

In a Jan. 17 release, the Reston, Va.-based firm said with CDC reporting “elevated influenza activity” the previous week in nine of the 10 regions of the country and with “certain areas reaching epidemic thresholds,” STS launched FluNada as “an over-the-counter product that provides cold and flu-like symptom relief in a fast action spray.”

STS says the product is indicated to treat cold and flu-like symptoms and was created by Steven Schwartz, a physician who also created AirVita, which uses the same blend of ingredients but is indicated for spray in the nose and mouth for an immunity-boost.

A testimonial on the firm’s website says: “I had a sore throat and the sniffles and wanted to nip my cold symptoms in the bud. … I am getting two more bottles to have on hand for everyone in my family so that we can be prepared for the cold and flu season ahead.”

Wasserman said the product name could bother FDA because it could be loosely translated to “No Flu.” However, he pointed out that under the agency’s regulatory framework for homeopathic products, FDA might not object to the claim, “especially if the product itself does not present a safety concern.”

MacKay said homeopathy claims are on the radar of FDA and FTC. “Firms aware of the regulations might be trying to push the limits of what’s allowed for homeopathic remedies to market their products for cold and flu,” he said.

“Ammo” For FDA, Congress

Welch said that though FDA acts most often against weight loss, sexual enhancement and bodybuilding products that make unsubstantiated claims or are found to contain drug ingredients, the agency will be “looking for flu claims” every winter.

“I know they’re out there. They’re always trying to capitalize on the latest health scare,” she said.

The 2009 swine flu epidemic spurred FDA to act against firms making flu claims. In a warning letter about Weil Lifestyle’s Immune Support Formula, FDA took issue with the firm's use of the titles "The Swine Flu - H1N1" and "Swine Flu and You" on its web site, which suggested Weil was marketing an unapproved drug. In a rare action, the Federal Trade Commission partnered on the warning letter and said the firm had to have adequate substantiation for claims Also see "FTC Stakes New Territory, Joins FDA In Warning On H1N1 Claims" - Pink Sheet, 19 October, 2009..

FDA in 2010 warned Cashburners, a website manager and host site for the Flu Defence product, and Nature's Gift, marketer of the Flu Foil Synergy, Flu Foil Synergy with Inhaler, Ravensara and Ravintsara products, that their claims made the products unapproved drugs ([A#05180240014_b]).

Flu-related claims for supplements also could heighten interest from members of Congress in tightening regulation of the industry.

MacKay said these claims “are ammo” for industry critics on Capitol Hill.

“We’re not supposed to do this and the more [the] medical community takes it seriously and says it’s an abuse of the category, and to the extent people want to regulate on behavior of bad actors, this could be an issue,” he said.

Welch agreed, pointing out Congress gave relatively little attention to the industry during 2012. The 113th Congress, however, could be “lying in wait. …We have opponents,” she said.

Flu Ushers In Risky Claims Season

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