Author Archive

In what may be considered highly encouraging and promising news for the supplement industry, Senators Orrin Hatch (R-UT) and Tom Harkin (D-Iowa) have asked FDA Commissioner Dr. Margaret Hamburg to withdraw the controversial NDI Draft Guidance — and replace it with a new draft that, according to the Senators, “will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”

As reported in yesterday’s American Herbal Products Association Update, Senators Hatch and Harkin — who were the principal authors of the Dietary Supplement Health and Education Act (DSHEA) and are in a unique position to comment on this controversial new draft guidance and whether it is consistent with DSHEA — wrote a letter to the FDA to formally ask them to withdraw the document.  In their letter, the Senators pointed out that the draft guidance “serves to undermine DSHEA in a number of important aspects” — and went on to note their many concerns with the draft guidance (which many experts in the supplement industry have been noting since this controversial draft guidance for NDIs was introduced.) Read the rest of this entry »

On November 2nd, the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi’s National Center for Natural Products Research (NCNPR) announced a collaborative effort to address “adulteration of botanical ingredients” and educate members of the dietary supplement industry on accidental as well as intentional adulteration through the Botanical Adulterants Program (BAP). The program has received support from many industry members, retailers and trade associations. Read the rest of this entry »

Chinese media sources (www.xinhuanet.com) report that China’s State Food and Drug Administration (SFDA) issued a circular on Friday requiring manufacturers of dietary supplements to tighten quality control over raw materials by reviewing the qualifications of raw material suppliers and inspecting the suppliers’ products regularly. The suppliers must improve the quality control of raw materials and manufacturers are directed to develop detailed records of raw material purchases to assist tracking the sources of raw materials. The SFDA also asked its local branches to more closely supervise manufacturers who use expensive and rare extractions from animals and plants and imported raw materials. The document threatened serious punishments for Chinese supplement manufacturers that use substandard raw materials. The agency pledged to both publicize and stop the distribution of unsafe supplements in China. 

Cross-contaminated raw materials from Chinese suppliers have long troubled the American supplement industry, prompting negative media reports, product recalls, and even criminal investigations. Recognition that tainted ingredients pose a serious problem is certainly a step in the right direction for Chinese authorities. Let’s hope quality control is improved not only for Chinese products, but for those raw materials that make their way across the Pacific to our shores.

A recent decision by FDA to reject a company’s citizen petition to classify homotaurine as a dietary ingredient may have far-reaching implications for the sports nutrition supplement industry.

Homotaurine was previously studied by a pharmaceutical company as an investigational new drug to treat Alzheimer’s disease. When the results proved disappointing for a viable pharmaceutical, the compound was withdrawn from clinical trials. But homotaurine showed enough promise for the company to form a subsidiary called OVOS Natural Health, Inc., which submitted a citizen petition to FDA in June 2009 requesting the promulgation of a regulation permitting the marketing of the New Dietary Ingredient (NDI) “homotaurine” for use in dietary supplements. Permission from FDA is required when a company is seeking to market a NDI that was previously investigated as a new drug. The company intended to market homotaurine not as a drug, but as a dietary supplement for memory protection. OVOS simultaneously submitted the required 75-day pre-market notification to FDA that it would be marketing the compound (under the brand name Vivimind).

Read the rest of this entry »

Last week, Citizens for Responsibility and Ethics in Washington (CREW), a legal watchdog group, released “research demonstrating that the dietary supplement industry spent millions of dollars on well-connected lobbyists and made numerous campaign contributions to successfully thwart increased regulatory oversight of supplements.” (Read CREW’s report here)

 CREW’s press release targeted Utah Republican Sen. Orrin Hatch as being “[f]ar and away the largest recipient of campaign contributions from the supplement industry in the 2010 election cycle” for taking in the apparently whopping sum of $45,780. 

  Read the rest of this entry »

Last month it was reported that about one-third of FDA’s 90 dietary supplement Good Manufacturing Practices (GMP) inspections in fiscal 2010 revealed severe compliance problems.  The most common GMP problem was reportedly “inadequate identity testing.”  Undoubtedly, relying on certificates of analysis from the raw materials supplier without further testing, or failing to conduct identity testing of a finished product, can result in the creation of a product that contains something it shouldn’t – such as synthetic chemicals or even pharmaceutical drugs.  However, a recent article in The Tan Sheet (10/11/10, page 4) refers to all of these products as “spiked” – even in situations where the presence of the undeclared ingredient is inadvertent.  The indiscriminate use of the term “spiked” by The Tan Sheet only serves to confuse the situation.  The most common use of the term refers to intentionally putting alcohol or drugs into someone else’s drink.  “Spiking” a product connotes intentionally slipping a powerful but undeclared ingredient into it to cause a desired or enhanced effect.  And that’s simply not always the case; particularly when you consider that some of the undeclared substances that have been reportedly discovered in some dietary supplement products are either contrary to, or would not enhance, the desired effect of the product and have been found in an amount that is unlikely to have any physiological effect.

 Certainly, there have been situations in the supplement industry wherein a domestic manufacturer, or even a raw materials supplier, has intentionally added an undeclared drug or chemical to the product to enhance its effect.  This is true “spiking” and it is our recommendation that the term be applied only to this scenario.  This is clearly a criminal act.  Manufacturers who “spike” products do so in violation of the FD&C, and if the undeclared ingredient is a controlled substance, the DEA also has jurisdiction. 

Read the rest of this entry »

San Francisco recently became the first major U.S. city to ban toys from kids’ meals that are laden with calories, sugar and fat.  In an effort to fight childhood obesity, the board of supervisors passed the measure stipulating that only meals with less than 600 calories and less than 35 percent of calories from fat, including a beverage, are permitted to include a toy.  Also, fruits and veggies would need to be offered with all kids’ meals.

The measure’s sponsor calls it “food justice” to protect the city’s children, “particularly kids from low income neighborhoods.”  But McDonald’s spokeswoman Danya Proud retorted in a statement, “We are extremely disappointed with today’s decision.  It’s not what our customers want, nor is it something they asked for … Parents tell us it’s their right and responsibility — not the government’s — to make their own decisions and to choose what’s right for their children.”

It’s true; adult consumers need to take primary responsibility for their health and the health of their children.  Government regulators shouldn’t be too heavy handed in restricting freedom of choice.  Banning goods or activities outright by a “nanny state” who “always knows best” worries the libertarian in me.  But, obviously, not every parent makes good decisions.  And kids are getting fatter, due to bad food choices and declining physical activity levels.  So are many adults, and the costs of obesity are passed on to the rest of us, reflected in rising medical insurance rates and costs to the taxpayers.  So, while we definitely don’t need the government — whether it’s at the local level or the national one — forcefully dictating what’s best for us, some gentle nudges aren’t necessarily too terrible.  The San Francisco measure doesn’t stop any kid — even a morbidly obese one — from getting a Happy Meal if he or she wants one and the parent thinks it’s wonderful.  It just nudges things in a healthier direction by connecting the toy (i.e., a reward) with the more nutritious choice.  Admittedly, it’s a small thing, and minor when compared to the parental responsibility factor.  But maybe it’s not such a bad start.

This weekend, the LA Times ran a story by Andrew Zajac about the “reinvigoration” of the FDA under the Obama Administration (check out the story here).  While the focus of the article was food, drugs, medical devices and over-the-counter items (e.g., mouthwash), there’s no doubt that the increased “regulatory activism” is also being expressed toward the dietary supplement industry.  While the article cites FDA warning letters sent to companies outside the supplement industry, a similar aggressiveness is being directed in the area of New Dietary Ingredients.  Recently, for example, a major sports nutrition company issued a nationwide recall of an anti-aromatase product after receiving word from FDA that the ingredient failed to meet the legal definition required for it to be sold as a dietary supplement.  Mr. Zajac’s assessment that “[t]he agency hasn’t gone full throttle yet” may especially apply to dietary supplement products that fall into the category of New Dietary Ingredients.  Industry should brace itself for increased scrutiny of products that were not sold in the United States as a dietary supplement before October 15, 1994.

This week, Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius released a draft report entitled the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.  In the face of widespread dietary misinformation and an epidemic of obesity, the draft report examines both what Americans are eating and what we should be eating, based on the existing science.  Written comments on the draft are welcome, and are encouraged to be submitted through July 15, 2010.  Oral testimony may be provided at a July 8 public meeting in Washington, DC.  When it’s finalized and released at the end of the year, the report will be the basis for the 2010 Dietary Guidelines for Americans and replace the 2005 Dietary Guidelines.

Read the rest of this entry »

The July 2010 issue of Consumer Reports (CR) magazine investigates protein drinks with not very flattering findings:

… [O]ur investigation, including tests at an outside laboratory of 15 protein drinks, a review of government documents, and interviews with health and fitness experts and consumers, found most people already get enough protein, and there are far better and cheaper ways to add more if it’s needed. Some protein drinks can even pose health risks, including exposure to potentially harmful heavy metals, if consumed frequently. All drinks in our tests had at least one sample containing one or more of the following contaminants: arsenic, cadmium, lead, and mercury. Those metals can have toxic effects on several organs in the body.

It’ll take some time to fully dissect the findings.  Obviously, nobody needs to ingest unsafe levels of heavy metals.  But 12 of the 15 did not contain unacceptable levels of any heavy metals in a full three (3) servings daily.  Of the 3 that did show unacceptable levels, again, it was only at 3 servings daily, not one or 2.  Only one product had levels of arsenic above the proposed USP limit.  Further, the USP limits are based on a person weighing only 110 pounds — considerably less than many if not most protein shake drinkers. Read the rest of this entry »