Just in case you have been trying to inhale your caffeine lately, you should stop.  The FDA issued a letter of warning to the makers of Breathable Food Inc.’s Aeroshot “caffeine inhaler” today, stating that there is a question of safety, particularly relating to children, teens and combining the product with alcohol.

The FDA claims that the company has “false or misleading statements” on their labels.  The labels tell consumers to “swallow” the product, which introduces caffeine into the lungs.  The stimulant is not normally inhaled, therefore the safety in doing so has not been well studied.

Aeroshot combated this claim, pointing to “decades” of research that show the particles in their product are too big to enter the lungs, but fails to cite specific data.

The Agency also complained that the product label does not provide contact information for consumers to report any problems they experience as a result of the product, as federal law requires.  Law also mandates that manufacturers ensure that a product is safe and properly labeled prior to sale.

Breathable Foods has 15 business days to respond to the Agency with a plan to correct the problems cited.

(Media Credit/Lea Aharonovitch via Flickr)

Women have worn it for centuries to add a hint of color to their lips, but consumer and environmental groups are raising concern over the lead in lipstick. The Campaign for Safe Cosmetics (CSC), which is composed of consumer and environmental groups, addressed the issue in a letter  earlier this month to the U.S. Food and Drug Administration (FDA). The group wants lead levels in lipstick to decrease, as they argue that there is no “safe level” for the metal.

In 2007, the CSC tested 33 lipsticks, including shades from top brands in the U.S., and reported that “two-thirds of the 33 samples we tested contained detectable levels of lead; of those, half were above the recommended limit for lead in candy.” In response, the FDA conducted its own study, using 20 of the same brands and shades the CSC had tested, which included shades from Revlon, Cover Girl and Estee Lauder. Initial FDA findings found the average lead concentration in the lipstick samples to be 1.07 parts per million (ppm), while an expanded survey, the findings of which were released in December of 2011, revealed the average concentration to be 1.11 ppm of 400 samples tested.

“This new report found higher levels of lead in lipstick than previously reported, and adds to our concern about the health risks of lead-containing lipstick–a product used by millions of women of childbearing age who are unaware that they may be building up their blood lead levels each time they apply lipstick,” the CSC said in the letter.

The group adds, “The most-contaminated brand, Maybelline Color Sensation made by L’Oreal USA, had lead levels more than 275 times the level found in the least contaminated brands, and more than seven times higher than the average found in all the lipsticks. Clearly, some manufacturers could be doing more to protect women from unnecessary lead exposure.”

Though the FDA has not set limits for lead in cosmetics such as lipstick, it has set limits for lead in color additives to “no more than 20 parts per million,” according to its website. The FDA also asserts that the lead in lipstick is “ingested only in very small quantities.”

In the letter, though, the CSC argues that last month, an advisory committee to the U.S. Centers for Disease Control (CDC) and Prevention recommended that the CDC  focus on “aggressive prevention efforts for lead exposure.” The letter continues, “Based on new information as well as new understanding of old data, the committee’s report asserted that there is no safe level of lead for children; that the low-dose effects of lead extend beyond the neurodevelopmental realm into cardiovascular, immunological, and endocrine effects; and that the health effects of lead exposure appear to be irreversible.”

The FDA asserts on its website, though, that consumers should not be alarmed, stating, “Although we do not believe that the lead content found in our recent lipstick analyses poses a safety concern, we are evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers.”

According to the FDA’s 2010 expanded survey of 400 lipsticks, the following lipsticks had the most lead contamination:

1. Maybelline Color Sensational in Pink Petal, 7.19 ppm.

2. L’Oreal Colour Riche in Volcanic, 7 ppm.

3. NARS Semi-Matte in Red Lizard, 4.93 ppm.

4. Cover Girl Queen Collection Vibrant Hues Color in Ruby Remix, 4.92 ppm.

5. NARS Semi-Matte in Funny Face, 4.89 ppm.

According to the FDA’s 2010 expanded survey of 400 lipsticks, the following lipsticks had the least lead contamination:

400. Wet’n'Wild Mega Mixers Lipbalm, <0.026 ppm.

399. Clinique Almost in Black Honey, <0.026 ppm.

398. L’Oreal Colour Juice in Cherry On Top, <0.026 ppm.

397. Lori Anne Mood in Blue, 0.03 ppm.

396. M.A.C Satin in M.A.C Red, 0.03 ppm.

The FDA announced yesterday that effective next year the labels of sunscreen products will contain new information to better inform consumers of sunscreen products’ levels of protection and ability to reduce the risk of skin cancer, early skin aging and sunburn.

Sunscreen products approved by the FDA for protection against both UVA and UVB rays can now be labeled as “Broad Spectrum.” Under the new labeling, says the FDA, “sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Products that have an SPF between two and 14 may be labeled as “Broad Spectrum” if they pass FDA testing, but only sunscreens that are SPF 15 or higher can state on their labels that they reduce the risk of skin cancer and early skin aging when used as directed. Sunscreens that are not “Broad Spectrum” or that are “Broad Spectrum” but have an SPF between two and 14 will now be required to display warning labels that read the following: “Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Additionally, manufacturers can no longer claim that sunscreens are “waterproof” or “sweatproof,” nor can they identify their products as “sunblock.” Manufacturers that claim their products are “water resistant” must include on the front label that consumers can expect the stated level of SPF while swimming or sweating for either 40 or 80 minutes. Claims of “instant” or “immediate” protection or claims of protection for more than two hours without reapplication will no longer be permitted unless approved by the FDA.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement, “The FDA has evaluated the data and developed testing and labeling requirements for sunscreen products so that manufacturers can modernize their product information and consumers can be well informed on which products offer the greatest benefit. These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”

Woodcock says that for the best sun protection, consumers should regularly wear “Broad Spectrum” sunscreen with an SPF 15 or higher and be sure to reapply. Consumers are also encouraged by the FDA to limit sun exposure especially between 10 a.m. and 2 p.m., to wear clothing to cover exposed skin in the sun and to reapply sunscreen at least every two hours.

The FDA released three additional regulatory documents, one of which, a Proposed Rule, would limit the maximum SPF on sunscreen labels to be “50+,” as there are insufficient data demonstrating that SPF values above 50 provide an increase in protection. An Advance Notice of Proposed Rulemaking for Dosage Forms will address the effectiveness and safety of sunscreen sprays and address sunscreen dosages. The third document, the Draft Enforcement Guidance for Industry, will aid manufacturers in understanding how to label and test their products.

The FDA is also reexamining the safety of sunscreens’ active ingredients.

Some 48 million Americans are afflicted with a form of food borne illness each year. The Food Safety Modernization Act, signed into law in January 2011, now gives the U.S. Food and Drug Administration wider latitude in protecting our food supply, including the ability to order recalls of tainted foods (previously, the agency could only negotiate with businesses to order voluntary recalls). (FDA)

Existing laws and oversight from the U.S. Food and Drug Administration (FDA) have done a decent job of keeping the vast majority of Americans safe from food borne illnesses, but several recent cases of contamination have put the spotlight on what more we can do to protect ourselves from unwittingly consuming harmful bacteria, parasites, viruses and toxins that could be lurking on our dinner plates.

The U.S. Centers for Disease Control (CDC) reports that, of the 48 million Americans afflicted with some sort of food borne illness every year, 128,000 are hospitalized and about 3,000 die. In response to this growing problem, in January 2011 Congress passed and President Obama signed into law the landmark Food Safety Modernization Act (FSMA), a comprehensive $1.4 billion bill that aims to stop outbreaks of food borne illnesses before they begin.

“This law makes everyone responsible and accountable at each step in today’s global food supply chain,” reports FDA Commissioner Margaret Hamburg. “This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.”

FDA inspectors have monitored domestic producers of seafood, juice, meat, eggs and poultry for decades, but the new law expands their powers to evaluate hazards in all kinds of food and to impose stricter standards on imported foods. Processors are now required to proactively take measures to prevent contamination, and must have plans in place for corrective action when something does go wrong. Smaller producers are exempt from some of the more onerous and costly provisions of the new law, but are nevertheless still responsible for maintaining the strict health safety standards set forth in its provisions. The new law also increases the number and frequency of inspections at both high-risk and non-high risk facilities. And the FDA can now order recalls of tainted foods; before FSMA’s enactment, the agency could only negotiate with businesses to order voluntary recalls.

Given that some 15 percent of our food supply—including 60 percent of fresh fruits and 80 percent of seafood—is imported, the new law also requires importers to verify the safety of food from their foreign suppliers and authorizes the FDA to block foods from facilities or countries that refuse inspections.

FSMA also provides funds for training, equipment and facilities at food safety agencies across federal, state, local, territorial, tribal and even foreign jurisdictions to ensure that all parties are up to snuff on the ways and means of preventing and containing food borne illnesses.

“Really this is a major victory for every American who will sit down at the dinner table and have more confidence that their food is going to be safe,” says Erik Olson of the Pew Health Group, one the most vocal of hundreds of nonprofits in favor of strengthening our nation’s food safety net.

The US Food and Drug Administration warned consumers to “use extreme care” when buying any kinds of drugs over the Internet that claim to prevent, treat, diagnose or cure the H1N1 or Swine flu virus.

The FDA warning comes after the government agency purchased and analyzed several products from the Internet that claimed to be “Tamiflu.”

“One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir,” the FDA said in a statement. The website was gone shortly after the FDA placed the order.

At the same time, the FDA also purchased four other products that arrived with various levels of Tamiflu, but were not approved for use in the US.

“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said FDA Commissioner Dr. Margaret A. Hamburg. “Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

Two prescription antiviral drugs are approved by the FDA to treat or prevent the H1N1 virus: Tamiflu and Relenza. Consumers can also visit FDA’s website for tips about how to protect themselves when buying medicines online.

Photo courtesty lanier67, Flickr.

The war on cigarettes has taken another step forward. The FDA has announced a ban on cigarettes, in effect starting today, that are “flavored” like any fruit, candy, or clove as part of the new Family Smoking Prevention and Tobacco Control Act.

Ninety percent of adult smokers started smoking when they were teenagers, so the FDA’s logic says that making cigarettes less appealing should keep more people form smoking. Likewise, 17 year old smokers are three times as likely as adult smokers to use flavored cigarettes.

The FDA has sent letters to tobacco industry officials explaining the law, and warning of stern penalties for those who continue to defy it.

“Youth are twice as likely to report seeing advertising for these flavored products as adults are,” said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner. “Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful.”

The FDA is also looking into regulating menthol cigarettes as well as other flavored tobacco products.

A former Pfizer district sales manager was found guilty of obstruction of justice Monday, the FBI said in a statement.

Thomas Farina, 42, of Fairport, N.Y., faces 20 years in federal prison and $250,000 in fines after he allegedly made a Pfizer sales representative delete evidence that promoted a company drug for off-label usage not approved by the Food and Drug Administration.

According to the FBI, Farina also had the sales rep. change the dates on a computer and “instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.”

Authorities said Pfizer has cooperated fully in the investigation.

Here’s the latest from Blast’s continuing coverage of the nationwide salmonella outbreak

QUINCY, Mass. — /USNewswire/ — Following notification from its manufacturer, The Stop & Shop Supermarket Company has recalled its Stop & Shop brand ice cream Sundae Cones. The item was removed from store shelves because ingredients in the product were from Peanut Corporation of America (PCA) and has the potential to be contaminated with salmonella bacteria. The product has a UPC # 68826706258 and contains 8 – 4oz. cones in each package.

Customers who have purchased the product should discard any unused portions or bring their purchase receipt to any Stop & Shop for a full refund. To date, Stop & Shop has received no reports of illnesses associated with consumption of this product.

Customers looking for additional information may call Stop & Shop’s corporate brands hotline at 1-877-846-9949, M-F, 9am-5pm.

Customers looking for more information on peanut product recalls relating to the recent salmonella outbreak can go to the FDA’s website.

Maryland-based Giant Food LLC, with 182 supermarkets in the Mid-Atlantic states, also recalled the same store-branded Sundae Cones ice cream cones.

Also, the Mars Company said in a statement Thursday that none of their products are affected by the recall.

The Food and Drug Administration has found Salmonella in recalled Austin brand sandwich crackers, a brand under the Kellogg umbrella.

“FDA has advised Kellogg Company that Salmonella was found in one package of Austin Quality Foods Toasty Crackers with Peanut Butter,” the FDA said in a statement Monday. “This product had previously been recalled by Kellogg, in one of a series of industry recalls relating to Peanut Corporation of America’s recall of peanut-based ingredients.”

“We apologize to our consumers and customers, and we can’t emphasize enough our disappointment and deep regret about this situation,” said David Mackay, president and CEO, Kellogg Company. “The food industry upholds certain operating standards and we are proud that we exceed these standards in our facilities. Events of the last week suggest there was a breach in this supplier’s process that is unacceptable to Kellogg, our customers and our consumers.”

The FDA has urged customers Jan. 14 to dispose of recalled peanut butter and peanut paste products.

Kellogg has promised an internal investigation.

“Based on our learnings from this experience and consistent with our 100-year commitment to quality and food safety, Kellogg will evaluate its processes to ensure we take necessary actions to reassure consumers and rebuild confidence in these products,” Mackay said.

According to the FDA, products impacted by the Kellogg recall were produced on or after July 1, 2008, including:

• Austin Quality Foods Cheese Crackers with Peanut Butter – all sizes
• Austin Quality Foods Cheese & Peanut Butter Sandwich Crackers – all sizes
• Austin Quality Foods Mega Stuffed Cheese Crackers with Peanut Butter – all sizes
• Austin Quality Foods PB & J Cracker Sandwiches – all sizes
• Austin Quality Foods Super Snack Pack Sandwich Crackers
• Austin Quality Foods Chocolate Peanut Butter Sandwich Crackers – all sizes
• Austin Quality Foods Toasty Crackers with Peanut Butter – all sizes
• Austin Quality Foods Reduced Fat Cheese & Peanut Butter Sandwich Crackers
• Austin Quality Foods Reduced Fat Toasty Crackers with Peanut Butter Sandwich Crackers
• Austin Quality Foods Cookie/Cracker Pack
• Austin Quality Foods Variety Pack
• Keebler Cheese & Peanut Butter Sandwich Crackers – all sizes
• Keebler Toast & PB’n J Flavored Sandwich Crackers – all sizes
• Keebler Toast & Peanut Butter Sandwich Crackers – all sizes
• Famous Amos Peanut Butter Cookies (2- and 3-ounce)
• Keebler Soft Batch Homestyle Peanut Butter Cookies (2.5-ounce)

On Friday, the Food and Drug Administration announced it traced a likely source of a nationwide Salmonella outbreak to a Georgia plant owned by Peanut Corporation of America, which produces peanut butter.

The plant also produces a peanut paste used in many products, including cookies, crackers, cereal, candy and ice cream. The FDA has urged the public to avoid peanut-including products.

Additionally, FDA has determined that some of the peanut butter is used in products consumed at large institutions, such as nursing homes and hospitals.

Responding, the Peanut Corporation of America shut down the Blakely, Ga. plant and recalled 21 lots of peanut butter produced on or after July 1, 2008.

“We deeply regret that this product recall is expanding and our first priority is to protect the health of our customers,” said Stewart Parnell, the company’s president, in a statement Friday. “Our company has worked around the clock for the last week with federal regulators to help identify any potential problems.”

Peanut Corporation of America also owns plants in Suffolk, Va. and Plainview, Tex.

In 2007, Peter Pan Peanut Butter, made by a different company, was pulled off store shelves worldwide after a similar bacteria outbreak.

This month’s contamination has been linked to 470 illnesses in 43 states so far and may also be responsible for six deaths.

By Tony Hendra

Want to defend $10,000 DDs (and the women who get them) or burst the silicone bubble? Tell us your position in the comment section.

Boobs are busting out all over. In the year since the Food and Drug Administration approved the use of silicone breast implants (do breasts go under Food or Drugs?), one million shiny new ¼ber-boobs have overflowed welcoming bras like rising dough foaming over bread pans, or strained provocatively against satin blouses and wet T-shirts, pert nipples on red alert. An estimated 500,000 American women have joined the approximately 4.5 million who already had chest extensions, waving good-bye to their S-class-driving nip-and-tuckers with a joyful “Thanks for the mammaries!”

To give you an idea of just how many perky new ¼ber-boobs that is: If you laid them end to end they would stretch from Clifton, New Jersey, to Columbus, Ohio!

We’ve got ourselves an ¼ber-boob explosion!

Actually, ¼ber-boobs can, in theory, explode. Under the right circumstances, lasers can ignite the hydrogen locked up in fresh silicone and it’s boobs away! The CIA is probably picking up the intensified chatter on Al Qaeda sites: Next spring break the bastards aim to infiltrate beaches from Key West to Cancun with undercover Islamo-maniacs carrying handheld lasers. A quick zap where bikini top meets armpit and Great Satan’s milk wagons go kablooey.

Freud famously asked, “What do women want?” He never got around to asking, “Why do women want boobs that feel like Porsche hubcaps?” Before I try to answer that question, a robust caveat: When handling the whole area of boobs, men—even feminist men like myself—tend to be insensitive. We hairy retro-primates assume that the self-sacrifice women endure to enlarge themselves has male pleasure as its only goal. Bigger funbags equals bigger fun, right? Not necessarily. Before we dive headlong into the Valley of Silicone, we must establish whom ¼ber-boobs are intended for.

Consider the harrowing tale of poor little Heidi Montag, who graces the insect-brained MTV series The Hills. The nightmare, the unending torment Heidi had to endure from puberty on, is just agonizing to hear about: She was “too flat.” “Mean boys” would say, “If you nailed two nails in a board, they’d be bigger than you are [hahahahahahahaha!!!].” Can you imagine?

Her courage in escaping that nightmare is as inspiring as it is empowering. She risked death. “Right before I went in, I was like, What if I don’t wake up?” she told US Weekly. Good question. What if? Her struggle is up there with suffragettes being beaten to a bloody pulp as they marched for the vote, or the long battle against brutal male chauvinism waged by Friedan, Steinem, and their sisters. What Heidi went through to get from A to C? MTV ought to spin it off. Call it Heidi’s Hills.

She did it for herself, okay? For her own self-esteem. It had nothing to do with Spencer or the Mean Boys or that slut Lauren (who, incidentally, hasn’t yet gone under the knife and boosted her acne bumps into something worth ogling).

Ogling? Oops. Down, retro-primate, down.

But I wonder. Why would a diaphanous sylph like The Heids saddle her upper half with a couple of humonga-gazongas when she looked just fine in the before shot? Especially since anyone with retinas can deduce that her neo-knockers are mostly liquid sand. How does knowing that others know that boost your self-esteem?

Are they really intended to inspire and empower other women? Hmmm. From what little I know of intimate female discourse, the owners of ¼ber-boobs are assumed to be—how to put this delicately?—morons. The thinking seems to be that even God-given 38Ds were fashioned at the expense of cerebro-cortical mass; wit and tit are inversely proportional.

Is it just possible that ¼ber-boobs are . . . for the lads? Other rumored recipients tend to bear out this wild hypothesis. Take the speculation, based on a flattering photograph that circulated on the Internet, that Ann Coulter had gotten implants. It would make sense, right? If she’s to maintain her role as the reigning Fox News fox, the ultimate eye candy of the loony right, she has to take her job seriously. A cold-blooded Cretaceous reptile must at least look like she can suckle her young.

Or take Posh Beckham, whose ¼ber-boobs, in shape and consistency, closely resemble two halves of a fully inflated soccer ball. Obviously those babies are for Becks, who must like the familiar feel.

Which raises the question: How do they feel? Marriage has limited my ability to conduct large-scale tests, but I do recall that awful moment when you plunge happily into soft pink abundance and come across something like one of those tiny helmets Hell’s Angels wear on their bald spots. Detumescence, thy name is silicone.

As for saline liquid, it’s alarmingly . . . liquid. It sloshes about. Few men—or women—are turned on by #252;ber-boobs that change shape as often as a minor Harry Potter character. Salty ¼ber-boobs do have one thing going for them, though: When you hold them up to your ear, you can hear the sea.

In a sermon several years ago—one he quoted again in October at Larry King’s behest—evangelist Joel Osteen urged the ewes of his flock to shop at Victoria’s Secret. The reason for this apparent lapse from the Christian right’s typical white-lipped terror of sex? Flirty underwear helps wives better please their scripturally mandated lords and masters.

Once you get past the pseudo-feminist claptrap, women who boost their boobs don’t seem a whole lot different from Joel’s ewes. Heidi, et al., are the real boobs, obediently conforming to some caricature of beauty fantasized by traveling-salesman types. Face it, O lovely woman: That shiny new bosom was fashioned by, and for, men. And you will wear it in public as long as men approve. You could say ¼ber-boobs are Western Civ’s equivalent of. . . a burka.