Hamburg

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. Remarks by commissioner Margaret Hamburg on Aug. 6 strongly suggest that the agency has shifted to a policy of less talk and more action. In a speech to the Food and Drug Law Institute, Hamburg said the FDA will be more vigilant, strategic, quick and visible.

To that end, Hamburg said the FDA has instituted six policy changes:

• Fewer, if any warnings. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” Hamburg said.
• Greater emphasis on swift enforcement. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses,” she said.
• Fewer warning letters. The letters are now limited to significant legal issues. “Most enforcement letters will be able to move forward through a more streamlined process.,” Hamburg said.
• Shorter post-inspection deadlines. “When the FDA finds that a firm is significantly out of compliance, we expect a prompt response,” she said. “The firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”
• More follow-up on enforcement actions. “After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices,” Hamburg said.
• Public notice of completed corrections. “We will provide to the firm a ‘close-out’ letter, indicating that the issues in the warning letter have been successfully addressed.”

In sum, a supplement maker can expect a knock on the door before getting a letter in the mail. If the FDA perceives a significant risk to public health, it will ask enforcement agencies to take immediate steps. In some circumstances, there will be no warning and no negotiation before a plant is shut down or a product is recalled.

Why is the change in policy needed? Hamburg, who has been on the job just 90 days,  pointed to slow action on serious violations regarding product quality; adulteration and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising. Agencies took to long to respond because of procedures and policies, she said.

The industry response must be to get better or get out. Get better at controlling ingredient quality; get better at manufacturing; get better at documentation; get better at advertising and marketing; get better at legal representation. Otherwise, get out of the business.

While the actions may seem harsh, they increase the public’s confidence in the dietary supplement industry, Hamburg said.  “The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”

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Manufacturers beware. Your regulatory problems may not be over when you pull a product from the store shelves. Matrixx Initiatives Inc. recalled its Zicam products on June 16 and three days later the Securities & Exchange Commission sent a letter of inquiry. The company said that it did not know what the regulatory agency wanted, according to an article in the Wall Street Journal.

Mattrix is a public company, so it serves many masters, including the SEC and shareholders. The company’s stock lost 70 percent of its value the day the recall was announced. Shares closed at $4.83 on June 23, down another 95 cents from the June 16 close.

As might be expected, users of Zicam products have sued Mattrix. Among the latest is a Fort Lauderdale attorney who defends homeowners against foreclosures. Not a likely plaintiff based on his practice, his claim is based on the fact that he lost his sense of smell in 2007. He attributes that to the use of Zicam and now he wants compensation for damages.

The SEC focuses not on customer, but shareholder losses. A letter of inquiry can be a first step into an investigation that can lead to civil and criminal charges. Or it can lead to nothing; the SEC does not comment on its actions until they are final.

Matrixx stock had survived the downturn in the general market. It was trading near a 52-week high of $19.74 when the Food and Drug Administration issued a warning about certain Zicam products. In May, the company reported that 2009 revenues had hit a record level and annual earnings per share had jumped 40 percent from fiscal 2008 levels. In the earnings press release, acting company president Bill Hemelt said, “The 11% increase in fiscal 2009 net sales was driven primarily by increased sales within our core Zicam Cold Remedy and Allergy/Sinus products.”

Zacks Investment Research had rated the company a strong buy, saying in a release dated May 8 that “The Zacks #1 Rank (Strong Buy) company has now topped the consensus forecast in each of the last 4 quarters with an average upside surprise of 28.48%.”

When a stock on a big upswing suddenly goes into a tailspin, the SEC takes notice. Even if the reason for the decline is obvious, there are questions to be answered.

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Outside the industry, the viewpoints were more pragmatic. Scot Long, an exercise physiologist and professor from Mississippi, weighed in, writing: “Bottom line, do I think that Hydroxycut is an evil product? No. I think many people abused this product (taking too much) and some may have even had pre-existing medical conditions. Do I recommend it to my students, clients and friends? Of course not. I do think, however, that Iovate Health Sciences could have made a safer product. But it shouldn’t shoulder all the blame.”

Marion Nestle, author of “Food Politics,”  wrote in her San Francisco Chronicle column, “I freely concede that most supplement companies make reliable products, but without federal oversight how is anyone – even a store clerk – supposed to know which ones they are. Some clerks may know their business, but in my experience few think critically about the products they are selling and most appear to take the manufacturers’ words at face value.”

After a Hydroxycut recall article was posted on FitSugar.com, a commenter who goes by the name Mondaymoos offered this first-person experience : “I never took diet pills for the purpose of losing weight. Me, and a lot of other people in the military, used them as a tool to work 12 hour shifts and still go out and have a life afterwards without racking up massive calories in energy drinks and soda. Was it a healthy decision, probably not. Did it work? Definitely yes.”

Consumers seem to know that there are no magic diet pills and that abusing a product is probably harmful. Thus, rhetoric that casts the FDA — or a manufacturer — as hero or villain does not sway consumers. They would rather know the benefits and risks of a product, and make an informed choice based on that.

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The Food & Drug Administration issued on May 1 a consumer warning to stop using Hydroxycut, the heavily marketed weight-loss product. The agency said that “some Hydroxycut products are associated with a number of serious liver injuries” and announced that the maker was recalling all products.

Did the FDA properly react? The warning cited 23 serious health problems, including jaundice, liver damage, seizures and cardiovascular disorders. One person has died from liver failure since 2002 when the Center for Food Safety and Applied Nutrition first received reports about liver damage associated with intake of Hydroxycut.

Some people — for reasons not totally understood — had adverse reactions to Hydroxycut, according to a research report cited in the FDA warning. Sometimes the individuals required serious treatment for liver damage. Other times, the people regained normal health when they stopped taking the product.

Until 2004, Hydroxycut contained ephedra, a substance that the FDA banned after a study found more than 16,000 adverse events associated with its use in dietary supplements. According to a recent label, the main ingredients in Hydroxycut are now the minerals calcium, chromium and potassium, plus what the company calls Hydroxagen Plus and HydroxyTea. The former contains leaf and rind extracts and the latter is a combination of tea and ginger extracts.

None are banned substances. And the  health hazard evaluation board acknowledged in its report that it “does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

The board concluded, “Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity.”

Some definitions are in order. According to a 2007 article in Toxicological Sciences, “Idiosyncratic hepatotoxicity is a rare and unpredictable event of liver injury affecting generally less than 1 in 10,000 patients treated with certain drugs. However, it is a serious clinical problem as it accounts for 10% of all drug-induced liver failure cases.”

And citing a study published in May 2005 in the Nature Reviews Drug Discovery, the article said, “Idiosyncratic hepatotoxicities are currently the main cause for Food and Drug Administration-mandated warnings, restrictions of use or even withdrawals of drugs from the market.”

So, the FDA puts great weight on idiosyncratic hepatoxicity even though it is uncommon and difficult to predict in a population. Given the level of uncertainty, did the FDA have other options? After conducting a risk-benefit analysis, could the agency have told the makers of Hydroxycut to add a warning to immediately discontinue use and seek medical attention if certain symptoms present themselves? Why did an average of three cases per year — none this year and only three last year — justify a ban and recall?

Here’s a clue from the report, which references the Center for Food Safety and Applied Nutrition as CFSAN:  “In discussions in March and April of 2009 with hepatologists Tse-Ling Fong, M.D. of the University of Southern California and William Lee, M.D. of the University of Texas Southwestern Medical Center, CFSAN has become aware of these physicians’ case series of patients with severe liver disease associated with the use of Hydroxycut. Two cases from this series, representing additional cases to the ones reported to CFSAN, underwent liver transplantation following acute liver failure.”

Were the doctors two of the three sources? And were their case series the underlying reason for such swift and final FDA action? The answers are not here, but they are needed.

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The FDA has just announced a massive recall of the popular weight loss supplement, Hydroxycut.

According to the FDA press release dated today, FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Hydroxycut is manufactured and distributed by Iovate Health Sciences.  As of this writing, both the hydroxycut.com and iovate.com websites are effectively “down” with all information having been stripped from their home pages.  Expect recall notices to be posted there shortly.

A long list of products are included in the recall.  They are:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

According to FDA, one death due to liver failure has been reported.   If there is real causation behind this announcement then this could be one of the largest supplement liability issues ever.

Stay tuned for more news as we receive it.

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The old saying that news travels fast and bad news travels faster could apply to the latest recall of dietary supplements. The Food & Drug Administration found sibutramine in almost three dozen weight-loss products distributed by Universal ABC Beauty Supply International Inc. of Brooklyn, N.Y. The products included Pro Slim Plus, 3 Days Fit and Eight Factor Diet.

The FDA publicized that Universal ABC was issuing a voluntary recall in a news release dated April 20. While the exact time is unknown, the news went on a Twitter feed called FDARecalls on the 22nd. The same day, the news also appeared on a Twitter feed called Foodalert.

The announcement hit the news wires and WebMD, too.  In some ways, the story was a replay of an earlier recall.  On Jan. 27, the FDA warned consumers not to take a dietary supplement called Venom Hyperdrive 3.0 because it contained sibutramine. The drug can be prescribed by a doctor for weight loss, but is not approved in the United States as a dietary supplement. And the FDA had warned of some of the products on the recall list as early as Dec. 22.

While Universal ABC does not have a Web site, several companies carrying the company’s products do. One of them, a B2B site called EC Plaza, identifies the manufacturer as being Shenzhen Technology Co. in Shenzhen, China. According to EC Plaza, the sales manager is named Mr. Mikey and the company Web site is the number 2. Another Web site, Sensational.com, says in a review that the product is a Japanese lingzhi supplement with the Chinese ingredient. The review lists as a product negative, “Manufacturer information unclear.”

The lack of a legitimate contact name and Web site should raise questions for a retailer or distributor. The biggest problem may be the speed with which negative news reaches audiences. The convenience and ease of Twitter and RSS feeds puts recall news ahead of the ability of most companies to respond. Only those firms that with plans in place have a chance to catch up and maybe get ahead of the news. Otherwise, all the search optimization tools that drive buyers to a particular product or online store will be used to highlight  company’s misfortune, intentional or not.

In that environment, a company and its products can suffer a huge hit to their public image.  The best plan is to know your products before they reach the market. And if efforts to maintain good manufacturing practices fail, have a response plan in place that involves every department — administrative, sales, marketing and customer service. A coordinated team effort is the only remedy.

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The recent recalls of peanuts and pistachios brings to mind public concerns about the safety of all foods, including nutritional supplements. There’s good reason to be worried, if a recent report on Chinese slimming capsules is accurate. A study by German scientists found that the product contained sibutramine, which is banned for use as a dietary supplement in the United States.

The danger is only partly the ingredient; the FDA does approve the use of sibutramine as an appetite suppressant for weight loss. The greater worry is that the substance was not listed on the product label.  And sibutramine is the culprit du jour; there may be other undeclared — and possibly more harmful — ingredients that unwitting distributors and retailers are today offering to their American customers as being natural and supporting good health.

The research scientists warned in their report: “Products available without a prescription whose contents are claimed to be purely herbal may nonetheless contain synthetic substances in concentrations far above the therapeutic range and may be a cause of poisoning.”

The researchers found anecdotal evidence of people becoming ill in Germany and Poland. On Jan. 27, the FDA warned consumers not to take a dietary supplement called Venom Hyperdrive 3.0 because it contained sibutramine. The agency said in a statement that “the pills can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke.”

Such is the stuff that lawsuits and stronger regulations are made of. The food poisoning incidents involving nuts are leading to civil and criminal action, multi-million dollar fines, and congressional calls for tighter regulation. The peanut recall could cost its industry as much as $1 billion, according to one estimate. The damage is bleeding into health food industry. An Oregon company that emphasizes healthful products, Paley’s, recalled some products because they might be tainted.

High-profile incidents with untested dietary supplements might lead to court and legislative action. At least dietary supplement one company recalled some of its stock of Venom because of safety concerns.

The German scientists formulated their solution in their report: “It would be desirable to implement the obligation to declare ingredients and dose. The marketability of the product must be checked, particularly in countries in which the ingredients are classified as prescription drugs and in which a pharmaceutically defined medicine is available.”

The U.S. system does not work that way. At present, self-reporting is more the norm.  That could change given consumer suspicions about food safety and the pressure on government to respond quickly and severely to the next food scare.

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What do sibutramine, rimonabant, phenytoin and phenolphthalein have in common? You can find them spread among the 69 brands of weight-loss pills identified by the FDA. The weight-loss segment of the industry will likely see even more scrutiny of its manufacturing practices now that the FDA has targeted products that it considers harmful or illegal. Among the name-brand products were StarCaps, which has all but shut down its Web site.

Of the four ingredients, the FDA says that sibutramine is a Schedule IV controlled substance, rimonabant is a pharmaceutical ingredient not approved in the United States, phenolphthalein has also been found to be genotoxic, and phenytoin poses a risk to consumers who are allergic or hypersensitive to the pharmaceutical ingredient.

Just how seriously does the FDA take this matter? In a release, the agency says, “More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace.  Many are labeled as dietary supplements or supplements.  FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market.”

Distributors and sellers would be well advised to stay ahead of the FDA. The first step is to review your good manufacturing practices. The federal rule that went into effect in June 2007 describes in detail the required steps. An overview can be found at the FDA Web site. Amendments were published in September of last year.

As you might expect, manfacturers are required to check their products so that they are not mislabeled. In the case of the 69 supplements, there were undeclared products. Discovery of those ingredients in part prompted agency action.

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The recall is detailed on the FDA website here.   As you may have heard, all of the recent salmonella-tainted products have contained peanut paste or peanut butter made at a Peanut Corp. of America plant in Blakely, Georgia.

GNC’s chews were sold in 60-count containers with the UPC 48107036942, with lot numbers ending 8275 and 8255.  Refunds are available by calling GNC’s customer service at 1-888-462-2548.

Anyone searching for a safe peanut based protein bar might want to try VPX Zero Impact MRB bars in peanut butter and jelly flavor.  I have it on good authority that VPX has confirmed its supply of peanuts is safe.  Tasty too!

Other protein or energy bar recalls include:

• Nature’s Path Peanut Butter Optimum Energy Bars
• TWISTED and TITAN Branded Nutrition Bars
• ZonePerfect Chocolate Peanut Butter Bars, ZonePerfect Peanut Toffee Bars and NutriPals Peanut Butter Chocolate Bars
• Clif and Luna bars containing peanut butter
• Creative Energy Foods, Inc. bars marketed under brands Can Do Kid, Isagenix IsaLean, Nestle, Zone, Think Thin, Promax 70, Promax, and Shaklee
• Supreme Protein brand Peanut Butter Crunch Bars and Caramel Nut Bars

Updates:

• The Center for Science in the Public Interest criticizes FDA’s response to the salmonella outbreak as inadequate and ineffective.
• The New York Times reports that the plant in Georgia that produced peanut butter tainted by salmonella has a history of sanitation lapses.
• CDC website on the salmonella outbreak.
• FDA searchable database of peanut products recalls.
• The Washington Post reports that Peanut Corporation of America knowingly shipped contaminated peanut butter twelve times in the past two years!

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