Thursday, September 23, 2010

Choice of Words Causes Confusion Over FDA Order On 2 Milk Products

The recent order of the Food and Drugs Administration for the recall of 2 milk products for babies has stirred some controversy over the use of the term "recall".

The FDA basically wanted Mead Johnson to pull out of the market its Alactagrow Bibo milk supplement and Sustagen Jr. Milk Drink Powder Vanilla flavor. The reason: non-compliance to the standard fat-level content for food for infants and young children.

The problem is the general public has been accustomed to hearing the term "product recall" used in reference to products deemed unsafe for human consumption. This is a fact that didn't escape Mead Johnson. It immediately came out with a clarification that its two products were safe for consumption.

Here's the official statement from Mead Johnson's president taken from the company's website:
Mead Johnson Nutrition clarifies issues on Philippine FDA order

In response to an administrative recall order from the Philippine Food and Drug Administration (FDA) to remove current supplies from distribution and sale, Mead Johnson Nutrition (MJN) Philippines assures consumers that there is no safety issue with the products Alactagrow® and Sustagen Junior®.

The Philippine FDA has issued a Class III order, the lowest level, which is used for products that have technical compliance issues. The regulatory definition of a Class III order specifically states that the use of or exposure to the product “is not likely to cause adverse health consequences.”

Safety is Mead Johnson’s highest priority and the company spares no effort to comply with the laws of all of the countries in which it operates. All of the company’s products are produced in accordance with the CODEX Code of Hygienic Practice for Foods for Infants and Children.

The Philippine FDA said it was issuing the order because the fat content in the products is below the new standard listed in the revised CODEX Standards for Follow-Up Formula, which it has recently adopted in the Philippines.

When the Philippine FDA recently adopted additional CODEX regulations applying specifically to follow-up formulas, Mead Johnson proactively cooperated and has stayed in frequent communication with the Philippine FDA to ensure that Mead Johnson products would continue to be available for the families that use them, and in compliance with the new regulations. The process of reformulating the products so that they comply with the new CODEX regulations is elaborate and requires considerable time so Mead Johnson requested a renewed Certificate of Product Registration (CPR) prior to the end of the product’s term. CODEX is an international organization that develops and promotes food standards.

Our company is committed to bringing safe, effective, nutritious and high quality products to meet the nutritional needs of the Philippines’ children.

We were surprised by the recall orders, but we are committed to resolving the issue with the Philippine FDA so that Mead Johnson can continue to offer the children in the Philippines the many nutritional benefits of Alactagrow and Sustagen Junior.

All of our products currently sold in the Philippines, including Alactagrow and Sustagen Junior, have passed stringent Philippine FDA health and safety requirements and are considered to be safe for consumption and of high quality. While the fat level requirement does not relate to the safety or quality of the product, Mead Johnson is taking steps to meet that requirement also.

Mead Johnson is launching today a reformulated version of Alactagrow that meets the new regulatory requirements. Work is also underway to develop an updated version of Sustagen to meet the revised standards.

Mead Johnson is committed to its mission to nourish the world’s children for the best start in life. Our company is involved in efforts to address malnutrition through a country-wide feeding and growth-monitoring program called Feeding Hope in partnership with Department of Social Welfare and Development (DSWD) and the non-government organization Kabisig ng Kalahi. In addition, since 1991 Mead Johnson has provided sustained support to children afflicted with rare metabolic diseases.

Consumer health and collaboration with the government and the Food and Drug Administration are Mead Johnson’s top priorities.

Paul Andrew Richards
President, Mead Johnson Nutrition

For more information, you may call Mead Johnson through 841-8222 and 1800-18885861.

Thursday, September 9, 2010

FDA Outlaws 5 Beauty Products For High Mercury Content

Here's another warning from the Food and Drugs Administration.

The FDA has deemed unsafe for human use 5 beauty products from Japan and Taiwan. It has ordered a ban on the 5 products. FDA inspectors have been instructed to start confiscating the products all of which were found to have mercury content way above the set limit.

The products are:

  • St. Dalfour Beauty Whitening Cream
  • Beauty Girl Papaya & Hawthorn Essence
  • Beauty Girl Ginseng & Green Cucumber
  • Beauty Girl Essence Aloe Pearl
  • Beauty Girl Olive & Sheep Essence

According to information online, long-term exposure to mercury may produce such symptoms as peripheral neuropathy or itching, burning or pain on the skin, skin discoloration and swelling.

You can read more about mercury and the dangers it poses in this Wikipedia entry.

Wednesday, September 1, 2010

Omega-3 Margarines - Health Claims More Like Health Hopes

Marketing and advertising have always been at odds with science and sticking with just the facts.
Embellishment, selective omission, even claims that are unverified even as advertisements carrying them are published, do not come close to running the gamut of tactics used to convince people to buy products that almost always start as an overpromise and often end up underdelivering.

One particular example is the benefit of the essential fatty acid or good fat omega 3 supplemented from a variety of sources like fish, flax seeds, walnuts, or olive oil, or simply taken in pill form, having been long touted as heart-protecting by counteracting the effects of the bad fats in the diet. There are a lot of companies in the world today claiming/asserting/offering a significant possibility that their omega 3 enriched product will lower the risk of heart disease – long before it is actually proven. With more and more people gaining access to information via the internet, the number of so-called do-it-yourself doctors or those who try to address their own health concerns without consulting a doctor, is also growing every year. There is plenty of information available online, though nothing beats actual testing.

Consider the following report with the current finding that omega 3 enriched margarines developed by Unilever failed to prevent repeat heart attacks, taken from

Omega-3 margarines fail to help in heart study

STOCKHOLM, Aug 29 (Reuters) - Giving patients with a history of heart attacks a margarine enriched with omega-3 oils in addition to standard drugs appears to make no difference to their chances of having a repeat attack.

A 40-month study of more than 4,800 patients showed taking low doses of omega-3 fatty acids in margarine did not significantly reduce rates of serious heart attacks and other cardiovascular events, Dutch researchers said on Sunday.

The finding raised questions about the benefits of omega-3, which has been shown in previous studies to make for healthier hearts. The margarines used in the study were developed for the researchers by food and consumer goods giant Unilever (ULVR.L).

Doctors, however, are unlikely to rush to change clinical practice. Many already prescribe omega-3 fish oil capsules, including GlaxoSmithKline's (GSK.L) Lovaza, to reduce triglycerides, a type of blood fat linked to clogged arteries.

"It will be viewed as a largely negative study and people who are enthusiasts for omega fatty acids will continue to be enthusiasts and people who are sceptics will continue to be sceptics," said Scott Wright of the Mayo Clinic in the United States, who was not involved in the research.

Daan Kromhout of Wageningen University, who led the study, told the European Society of Cardiology the lack of efficacy might reflect the good background drug treatment patients were receiving, with 85 percent on cholesterol-lowering statins, as well as blood pressure and blood-thinning tablets.

"We found the cardiovascular mortality rate in the study population was only half that expected, probably because of their excellent treatment," he said.

"This may also be why the rate of major cardiovascular events during follow-up was no lower in the fatty acid groups than in the placebo group."

All the men and women in the Dutch study were aged between 60 and 80 and had suffered a heart attack roughly four years previously.

They were randomly assigned use of one of four margarines on bread instead of their regular spread -- one containing no extra omega-3 fatty acids; one with 400 milligrams a day of extra eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); one with 2 grams of alpha-linolenic acid (ALA); and one with a combination of EPA-DHA and ALA.

Fish like salmon, herring and sardine are a common source of EPA-DHA, while ALA is found in vegetables including soybeans, flax seeds and walnuts.

Despite the overall negative results, researchers did find there was a reduction in repeat heart attacks and other cardiovascular events in women who took ALA margarine, although this was not statistically significant. Diabetes patients also showed a possible benefit.

Unilever, whose margarine brands that contain omega-3 include Flora and I Can't Believe It's Not Butter, said the lack of benefit seen with EPA and DHA was surprising, considering the weight of evidence published to date.

"The results indicate that more investigation is required into the efficacy of vegetable omega 3, but do not question the current authoritative dietary recommendations and advices for omega 3 intakes on which our products are based," the company said in a statement.

The results of the study, which was supported by the Netherlands Heart Foundation, the National Institutes of Health, and Unilever, were also published in the New England Journal of Medicine.

Instead of taking the report at face value, it is better that some key points or questions be raised.

Specifically, the study leader attributes to a supposedly high level of drug care the failure of the omega 3 enriched margarines to prevent subsequent heart attacks, which gives rise to a few questions:

Does it mean that supplemental omega 3 is worthless for preventing heart attacks unless drug care is suboptimal or sub par?

Are the observed and measured improvements from omega 3 intake from margarines so marginal compared to the effects of the drugs administered that it seems unnecessary to add the omega 3 enriched margarines in the diet in the first place?

Why conduct a study that does not isolate omega 3's supposed beneficial effects, i.e., why were the test subjects taking drugs that could skew the results and make the effects of the drugs indistinguishable from the effects of the omega 3?

This study design appears to have ensured success of at least one of the means to counter heart disease, because if the design were different, like say, there is no effective drug care given and the omega 3 enriched margarines still fail to make a statistically significant difference towards preventing future heart attacks, the failure would be definitive – a nightmare for the “healthy” brands involved. In the end, the recommendation of “more investigation needed” gives the brands involved in the study the chance to still ride on consumer preconceptions and continue selling.
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