Finally, after several years of back-and-forth between regulators, watchdog agencies and companies, the FDA successfully passed new federal requirements last December, which ban potentially misleading terms like “waterproof” and require that all sunblock products provide protection from both UVA and UVB rays.

A recent survey of 1,400 sunscreen products conducted by the Environmental Working Group found that most products currently on the market meet the new requirements. While this is certainly a major step in the right direction, the regulations do not cover the long-disputed use of SPF ratings over 50, which many experts consider misleading.

Because consumers (quite reasonably) expect that SPF ratings of 100 indicate twice the protection of SPF 50, experts fear that people develop a false sense of security when using such products, leading them to stay in the sun without reapplication long after the effectiveness of the sunblock has worn off. In actuality, there is little difference between SPF 50 and anything above – while an SPF 50 product might protect against 97 percent of harmful rays, an SPF 100 product might block 98.5 percent — nowhere near a 50% improvement. continued…

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Wrigley‘s newly released Alert Energy caffeinated gum, which contains roughly 40mg of caffeine per piece, found itself in the hot seat in light of the new FDA probe. The company initially insisted that its product was intended for (and marketed to) adults, saying, “Millions of Americans consume caffeine responsibly and in moderation as part of their daily routines,” but after discussing the issue with the regulatory body, Wrigley has changed its tune.

“After discussions with the FDA, we have a greater appreciation for its concern about the proliferation of caffeine in the nation’s food supply,” Wrigley North America President Casey Keller said in a statement to the AP. “There is a need for changes in the regulatory framework to better guide the consumers and the industry about the appropriate level and use of caffeinated products.” continued…

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Michael Taylor, the FDA‘s deputy commissioner of foods, said that the only time the FDA explicitly approved the practice of adding caffeine to a food or drink was in the 1950s when it allowed the stimulant to be included in cola. The current prevalence of caffeine-filled foods is “beyond anything FDA envisioned,” Taylor said. “It is disturbing…We’re concerned about whether they have been adequately evaluated.”

The governing body is especially concerned when it comes to the effects of such foods on children; while kids aren’t likely to seek out a boring cup of joe, they may be more apt to grab a bag of jolt-inducing jelly beans. The American Academy of Pediatrics has linked caffeine to harmful effects on young people’s still-developing neurological and cardiovascular systems. So, while the FDA is already investigating the safety of energy drinks and energy shots (thanks to consumer reports of illness and death), the organization has decided to go a step further and look specifically at the foods’ effects on children.

Companies that manufacture and market caffeinated foods say that their products are intended for — and marketed to — adults. Wrigley, which recently released Alert Energy Gum (40 milligrams of caffeine per piece), pointed out that packages of the gum are labeled “for adult use only.” A spokesperson for the company said, “Millions of Americans consume caffeine responsibly and in moderation as part of their daily routines.”

While that may be, critics say it’s not enough for companies to say they are marketing the products to adults, who are capable of making more informed decisions about the amount of caffeine they consume, when the foods themselves are clearly attractive (and readily available) to children. In a letter to the FDA, Michael Jacobson, director of the Center for Science in the Public Interest, said of such foods: “One serving of any of these foods isn’t likely to harm anyone. The concern is that it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine to candies, nuts, snacks and other foods.”

In acknowledgement that the consumption of one caffeinated item may not cause adverse effects, the probe will focus on the effects of added caffeine in its totality, and whether the increasing number of caffeinated products on the market might mean more adverse health effects for children.

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AquaBounty Technologies (ABT), a biotechnology company in Massachusetts, has developed a fish called the AquAdvantage Salmon, which grows twice as fast as its naturally-bred counterparts. Pending FDA approval, this flashily-named fish could be the first genetically-altered animal marketed for human consumption. We’ve previously discussed the fact that there is no law on the books requiring genetically modified foods to carry labels identifying them as such — and this makes matters even sketchier. Unless customers purchase organic or “free range” seafood, they won’t know whether the fish they’re buying is plain old farm-raised salmon or this new brand of “frankenfish.”

Here’s the quick (and extremely simplified) version of how the “AquAdvantage Salmon” engineering process works: Atlantic salmon don’t grow continuously because their growth hormones are only active for roughly three months per year. In order to “fix” this, ABT created a new gene construct that combines a regulator gene from a fish called an ocean pout with the growth hormones of Chinook salmon. This combination is then injected into the eggs of Atlantic salmon–and the resulting fish take 18 months to grow to the same size regular salmon spend three years achieving.

The company claims that the frankenfish is an answer to global food shortages thanks to its “shorter production cycles and increased efficiency of production”.

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The 13 deaths cited in this story easily top the five blamed on Monster, and the details are even more troubling: the popular wake-up shot with the awful commercials was mentioned in approximately 90 filings since 2009 and linked to everything from heart attacks and tremors to “a spontaneous abortion”. We’ll bet everyone at distributor Living Essentials and its parent company Innovation Ventures just loves that phrase.

As expected, the FDA tempered its reports with conditional statements–and a Living Essentials rep defended the company by claiming to be “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.” The fact that regulatory authorities classify the product as a “dietary supplement” further complicates the issue.

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Not thrilled with the idea of your little tikes loading up on “jacked up” cracker jacks and bouncing off the walls? Fear not! PepsiCo (parent company of Cracker Jack makers Frito-Lay) assures us that it will only market the soon-to-be-released Cracker Jack’d Power Bites to adults. Not buying it? Neither is the Center for Science in the Public Interest (CSPI), which charges that the planned snack violates federal food regulations.

In a letter to the Food and Drug Administration, CSPI argued that “Caffeine is generally recognized as safe only in cola-type beverages and only at concentrations of 0.02% or less (about 72 mg per 12 oz.).”

When asked about these allegations, a Frito-Lay spokesman told Ad Age that Power Bites will include “two flavors that will contain coffee, a natural source of caffeine, as an ingredient…We stand by the safety of all products in the Cracker Jack’d line, including those that contain coffee. It is worth pointing out the regulation referenced in CSPI’s letter to FDA speaks to caffeine–not coffee–and is not an exhaustive list of the safe uses of caffeine in foods and beverages.”

The FDA wasn’t the only organization to receive a strongly-worded note from CSPI.

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After learning in June that a Right to Know initiative mandating GMO labels would appear on California’s ballot this year, observers engaged in a good bit of speculation over how the agricultural and chemical corporations that create these products would handle an industry-wide PR issue. The answer came in the form of a $46 million PR effort that blitzed radio waves and flooded mailboxes with negative advertising.

Those ad dollars now seem well-spent: voters defeated Prop 37 at the polls yesterday by a margin of 54 percent to 46 percent. The initiative would have required the packaging of all processed foods to bear the labels “partially produced with genetic engineering” or “may be partially produced with genetic engineering” by 2014. The rule also would have required “genetically engineered” labels for produce and prevented the producers of GMO products from using words like “natural” or “naturally made” in their advertising.

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A certain big-deal organization known as the FDA just released a report asserting that as many as five people died over the past three years after drinking Monster. While the report draws no direct, indisputable link between Monster and the tragedies in question, we can all agree that this sort of story is every company’s worst PR nightmare.

The victims, all of whom were teenagers, had a couple of crucial factors in common: each of them drank one or more 24-ounce cans of Monster less than 24 hours before dying of heart failure. The FDA also received multiple reports of consumers experiencing problems like “abdominal pain, vomiting, tremors and abnormal heart rate” after drinking Monster.

Does the drink really pose a risk to the general public? While every can contains 240 milligrams of caffeine, company representatives note that the average 16-ounce cup of coffee contains even more of the potentially damaging stimulant. That point may be irrelevant, though. The case got a lot bigger last week when one of the victims’ mothers responded to her daughter’s death by filing a lawsuit against the publicly traded company; its stock prices (NYSE: MNST) fell accordingly.

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Rob Kelley, FootJoy’s director of brand marketing, explained that Innocean “demonstrated a deep understanding of the game, our business and the ability to capture the consumer’s attention through fully integrated campaigns across all channels, just a few of the factors that led to their selection in this review process.”

The FDA has selected six agencies to work on its anti-smoking educational campaigns. The agencies, which will support different responsibilities under the new effort, include Interpublic Group‘s Campbell-Ewald, True North Communications, Mullen Communications, WPP’s Grey Global Group, the independent agency Riester and the American Legacy Foundation. Some agencies will allocate work to agency partners. The campaigns are mostly funded by tax-like fees from tobacco companies, which collectively involve a maximum of $390 million awarded over five years. continued…

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The FDA held public hearings just last week to discuss establishing guidelines for pharmaceutical marketers operating in the new world of social media. Already some are complaining that the process is taking too long.

“Does the FDA get it?” If it did, “they wouldn’t be having this meeting now, many, many months after it was already apparent how quickly Web communications is changing,” Mark Senak, author of the blog Eye on FDA and a senior vice-president at Fleishman-Hillard told BusinessWeek.

John Bell, President of the Board of Word of Mouth Marketing Association and Managing Director, Ogilvy Public Relations Worldwide agreed that things will take a while. “We’re spending time today in initial discussions that is as much about how the process should unfold as it is what should be the precise guidelines,” he told PRNewser last week.

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John Bell, President of the Board of Word of Mouth Marketing Association and Managing Director, Ogilvy Public Relations Worldwide, was one of the last presenters today at the FDA’s public hearings on “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” We caught up with Bell late yesterday to get his take on the proceedings.

Asked about how much of the hearings pertained to advertising and how much pertained to PR, Bell said, “Today’s stated focus is about what guidelines should be developed for social media, which is this netherworld in between paid and earned media. Unfortunately it covers all grounds.”

Part of the problem, Bell said, is that health-care marketers, “can’t jam all the crap you put into a print ad into a tweet.” So, what is end game with all of this? “We’re spending time today in initial discussions that is as much about how the process should unfold as it is what should be the precise guidelines.” PRNewser’s takeaway: this is going to take a while.

Bell and WOMMA were heavily involved in the recently issued FTC guidelines around disclosure in social media. Drafts for those guidelines were posted for comment late last year, he said, and the final draft came out in October. “I think what will happen with the FDA, is basically to kind of follow the same process,” he said.

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