Marketers of sports supplements must not only be careful as to who is manufacturing their products, but where they, or their manufacturers, are getting their raw materials. As part of the GMP practices, distributors must also make sure their raw materials are in compliance.

This obligation can be complicated by overseas suppliers where there may be less regulatory oversight. However, a recent development in India shows that this might be changing.

A regional government in India has suspended the license of an herbal drug manufacturing company for allegedly mixing steroids and other pharmaceutical products. In addition, the owner of the company and a distributor were charged criminally.

Why is this important?  While it is good business to try and find your ingredients for the cheapest price possible, one cannot sacrifice quality for price if it will end up being more expensive in the long run. Such a decision could ultimately result in a product recall or costly class action litigation.

Though overseas governments may take action when their laws and policies are violated, one should not and cannot rely on that enforcement. Know your supplier. Have your raw materials tested and validated. It will save a lot in the long run.

Read the full story at: http://www.expressindia.com/latest-news/punjab-suspends-pharma-firms-licence-for-mixing-steroids-in-herbal-drugs/644068/

The Federal Trade Commission’s first probiotic claims case has concluded with Nestle HealthCare Nutrition agreeing to drop claims that its children’s drink, BOOST Kid Essentials, could reduce illness-related absences from school or daycare. In the first of what is shaping up to be several investigations centered on probiotic products, FTC concentrated on whether claims about BOOST’s immunity protection were backed by results from clinical studies.

FTC feels that the studies Nestle relied on to prove their case could not adequately link reduced absences to the alleged immunity-boosting properties of their product, citing issues such as the original cause of the absences and how that was related to the outcome.
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When doing a review of your labels and advertising material, you think about Federal regulations and the risk of state Attorney Generals or district attorneys investigating your claims, but what about private attorneys?

You may believe that the only worry you could have about claims from a private attorney concern the physical injury resulting from the consumption of your product.  You may think that based on your ingredients you do not have much to worry about because the risk of someone being injured is very small.  However, there is a rise of another type of claim, one that is more dangerous and more expensive than a personal injury claim.

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In a House and Senate conference of the Wall Street Reform Bill and Consumer Protection Act, conferees ultimately decided not to include the broad rulemaking authority granted to the Federal Trade Commission (FTC) in the House version of the bill advocated by Congressman Henry Waxman (D-CA). This is a huge win for the nutritional supplement industry, as the rulemaking authority that would have been bestowed on FTC could have had a dramatic impact on industry, allowing the Agency to issue Rules under the Administrative Procedures Act that directly and significantly affect advertising. Currently FTC primarily “makes law” through enforcement of existing law. Getting this proposal removed from the final legislation was achieved through the help of overwhelming grassroots support in the form of messages from constituents to their representatives, and a combined effort of industry trade organizations including NPA and AHPA educating consumers and lobbying Capital Hill. I am proud to say that I personally spent a day on the Hill meeting with Representatives and U.S. Senators from New York and California, educating them on the issues and advocating on behalf of industry.

June 25, 2010 –  Today marks the date by which small businesses, meaning dietary supplement manufacturers with less than 20 employees, must be compliant with the current Good Manufacturing Practices (cGMPs) for dietary and nutritional supplements. It has been nearly 16 years since the Dietary Supplement Health and Education Act (DSHEA) was passed. DSHEA contained a provision requiring that FDA establish and enforce cGMPs, and while drafts were presented for comment over the years, it was not until 2007 that the cGMPs were finally approved, along with a three phase process for enactment, the final phase taking effect today. Read the rest of this entry »

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.

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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 »

Some law-makers in Washington have been asking, how did “hidden steroids” get into bodybuilding supplements when the amended steroid law of 2004 was supposed to have solved the problem?  Supplement industry critic Senator Arlen Specter [D-PA] chaired a Senate subcommittee hearing last September (http://judiciary.senate.gov/hearings/hearing.cfm?id=4081) to get some answers from DEA and FDA brass. The Senator appeared committed to solving the problem by reportedly working on a bill tentatively entitled the “Designer Anabolic Steroid Control Act of 2010.”   Read the rest of this entry »

The Senate Special Committee on Aging has scheduled a hearing entitled, “Dietary Supplements: What Seniors Need to Know.” The hearing, scheduled for 2 pm on Wednesday, May 26, 2010, will include testimony from the General Accountability Office concerning its investigation into “marketing practices” for herbal supplements.  Although the focus may be on the potential interactions between herbal products and prescription drugs, speculation is that questions about ”New Dietary Ingredients” may also be a highlight. Go to http://aging.senate.gov/ on the day and time of the hearing to view the live webcast.

Dr. Margaret Hamburg

In a March 4th letter to Senator Chuck Grassley, the Ranking Member of the Committee on Finance, Commissioner Margaret Hamburg indicated that FDA plans to “increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officers accountable” and has developed a yet to be released criteria for determining when these criminal prosecutions will be used. This letter was in response to a report released by the Government Accountability Office (GAO) entitled: Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations. Read the rest of this entry »