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Posts Tagged ‘FDA’

FDA Wants to Help Pharma Brands Get Honest on Social Media

Paging Dr. Oz: the FDA has finally, officially made statements to the effect that the companies selling the sedatives required in order to watch your show should practice a bit of honesty on social media.

They’re only suggestions in draft form at the moment…so in the words of Donald Draper, “Take a pill and lie down.

Now let’s check out those guidelines.

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FDA Reveals Gender-Based Double Standard in Big Pharma Research

big pharmaQuick poll: Anyone take prescription drugs? Okay, while we count the waving sea of raised arms out there in PR land, the FDA will thank you. Now, for you women out there in that sea, guess what? Big Pharma research is sexist.

No, really. And the FDA just proved it.

A recent study by the U.S. Food and Drug Administration proves that a gender-based double standard exists when it comes to tracking the side-effects of popular prescription drugs.

What was that song about bad medicine again?

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PR Win: Chobani Contains ‘Contaminated Yogurt’ Story

This morning brings a good example of a food brand nipping a potential PR disaster in the bud via social media: Greek-style yogurt giant Chobani had to recall all cups made at its Idaho plant due to mold contamination. Unfortunately, the company has received multiple reports of “bloated cups, odd-tasting yogurt, and, in some cases, gastrointestinal illness” over the past week.

The company tried to resolve the problem quietly before the FDA launched a review, then got out in front of the story by formally announcing a “voluntary recall” of all cups produced in Idaho during the period in question:

The brand’s social media response was quick, aggressive and personal.

With New FDA Rules, Gluten-Free Actually Means No Gluten (Mostly)

New FDA rules now say that food marked “gluten-free” can’t have levels of gluten that exceed 20 parts gluten per million parts of food. In addition, these foods can’t contain rye, barley, wheat, or any crossbreeds of those items. According to Business Insider, this is the lowest level of gluten that can be detected and the new rule puts our gluten-free standard on par with those in other countries.

This is the first time we have legally binding rules about gluten-free foods in place. They come along with new high standards for foods marked “sodium free,” “sodium free,” and “sugar free.”

For people who suffer from celiac disease, it must be a relief to know that what they’re getting is actually following the most strict guidelines available. There are three million people suffering from celiac disease. About 18 million are gluten sensitive. And then there are those who are going gluten-free to lose weight through regimens like the paleo diet.

This is a $4.2 billion market.  For brands, there’s good and bad with these new rules.

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Naked Juice Bares All in False Advertising Settlement

Naked Juice bottle Today in Put Your Clothes Back On news: we can add Naked Juice to the quickly growing line of foodstuff brands settling class-action lawsuits over deceptive health claims. Parent brand PepsiCo clearly missed the message about transparency being the best PR practice around, effectively admitting in the settlement that its “all natural” marketing claims are less than 100% accurate.

We’re not talking pasteurization here, people: the smoothie fakers include such “unnaturally processed and synthetic” ingredients as zinc oxide, ascorbic acid, and calcium pantothenate, all of which sound better suited to a meth lab than an orange grove (insert your Breaking Bad shout out here). In fact, that last one is derived from formaldehyde, to which we say: ewww, man. Ewww.

The juice may taste good, and it’s a hell of a lot healthier than much of the stuff we shove into our faces on a regular basis, but it’s hardly the “freshest” or the “purest” thing around, no?

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Deceptive Sunscreen Marketing Gets FDA Attention

As Memorial Day Weekend approaches, you’ll likely find yourself standing in the sunblock isle of your local pharmacy in preparation for barbecues, patio parties and picnics. But how do you choose the product that’s best for you and your family? If you usually feel lost in a sea of SPF numbers and buzzwords like “waterproof”, you’re not alone; the FDA has been working to crack down on sunscreen labeling for years in an effort to empower the public to make informed decisions about sun protection.

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. Read more

Update: ‘Wrigley’ Pulls ‘Alert’ Caffeinated Gum in Light of FDA Concerns

We told you on Monday about the FDA‘s investigation into foods with added caffeine, the organization’s  main concern being that the current proliferation of caffeinated foods on the market (drinks, energy shots, candy, snack mixes, etc.), may be causing people, especially children, to consume unhealthy and potentially unsafe amounts of the stimulant.

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.” Read more

Marketed to Adults, but Hurting Kids? FDA Launches Investigation Into Foods With Added Caffeine

Once upon a time, when a person needed a morning jump-start or a midday pick-me-up, they reached for a cup of coffee. These days, though, coffee has some serious competition; weary folks can now choose from an array of amped-up foodstuffs, including gum, concentrated energy shots, candy, and even caffeinated Cracker Jacks.

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 disturbingWe’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.

Frankenfish: The GMO PR Wars Continue

The PR battle over genetically modified food (and how/whether it should be labeled) just got fishier.

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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Bad PR: FDA Cites 5-Hour Energy in 13 Deaths

5-Hour EnergyIt’s tough to peddle caffeine these days unless you brew coffee, isn’t it? This week brought controversy over “Jack’d Cracker Jacks” while last month saw the FDA issue a report tying Monster Energy Drink to at least five deaths around the country. N0w we hear of yet another report linking the popular 5-Hour Energy drink to even more fatalities.

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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