Currently browsing posts about: Supplements

I am indebted to food safety lawyer Bill Marler for enlightening me about these pills in the first place, and their contamination with Salmonella.

The Centers for Disease Control and Prevention and the Kansas Department of Health and Environment have linked one  person’s Salmonella Oranienburg infection to taking rattlesnake pills. Rattlesnake pills are often marketed as remedies for various conditions, such as cancer and HIV infection. These pills contain dehydrated rattlesnake meat ground into a powder and put into pill form. CDC recommends that you talk to your health care provider if you are considering taking rattlesnake pills, especially if you are in a group more likely to get a severe Salmonella infection.

Can’t wait to hear what your health care provider says about these.

I know that everyone loves chocolate, but to snort???

The FDA, ever on the job, has issued a warning letter to Arco Globus Trading that its snortable Coco Loko product–cocoa powder infused with caffeine, gingko, taurine, and guarana–is being marketed illegally as an unapproved street drug.

the claims made in your promotional materials for Legal Lean Syrup and Coco Loko demonstrate that these products are intended to be used as alternatives to illicit street drugs…With respect to Coco Loko, a powder substance, you describe it in your labeling as a “snuff” and you promote it to be “snorted” (inhaled intranasally).  Intranasal administration of a powder substance can trigger laryngospasm or bronchospasm and induce or exacerbate an episode of asthma.  Furthermore, the ingredients listed on the product label for Coco Loko include taurine and guarana.  The safety of these ingredients for intranasal administration has not been evaluated.

I can’t find an official website for the product (it seems to have disappeared) but the FDA says that Coco Loko does not qualify as a supplement (it is snorted, not eaten, and it actually intended for use as a street drug:

• “Endorphin rush . . . it triggers a positive feeling of well being in your body similar to morphine.”
• “Serotonin rush . . . will produce an elevated mood and a state of euphoria similar to the feeling of ecstasy.”
• “Euphoric energy . . . Raw cacao will give you a steady rush of euphoric energy . . ..”
• “Raw cacao . . . is also known to help with anxiety and to reduce stress.”
• Coco Loko Review by I Suck At Talking (Youtube video on your website): “Raw cacao is linked to numerous health benefits . . . lower blood pressure and improved blood circulation . . ..” (1:04 – 1:13)

Snorting cocoa powder?  Really?  Not a good idea (even though no calories that way).

You can’t make this stuff up either.

The FDA is taking comments about developing a list of dietary supplement ingredients in safe use before Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994.

It announced a public meeting for October 3 ton this issue.

The FDA also announced that it is accepting public comments on its draft guidance. on New Dietary Ingredients (NDIs).

Here are the FDA documents:

• Federal Register Notice Announcing the Public Meeting
• Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry
• Federal Register Notice for the Draft Guidance
• Background and Information about Submitting NDI Notifications
• Public Meeting page

What this is about

A timeline may help:

• 1994: Congress passed the Dietary Supplement Health and Education Act which essentially deregulated dietary supplements.
• It did, however, require marketers of “New Dietary Ingredients (NDIs)” to submit a premarket notification to the FDA at least 75 days before introducing it—unless the ingredient had a history of safe use before that date.
• 1997: FDA issues regulations for NDIs
• 2011 (January): The Food Safety Modernization Act passes.  This required the FDA to clarify when an ingredient is considered NDI.
• 2011 (July):  FDA publishes draft guidance
• 2017 (September):  FDA issues draft guidance for comment

As the FDA explains, one purpose of this guidance is to improve compliance with the NDI notification requirement.

In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year. This is in contrast to the approximately 4,000 products that were on the market in 1994, when DSHEA was enacted.

As of December 2014, we had received and completed our evaluation of just over 750 NDI notifications since the first notification was received in 1995.

These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles

The FDA also explains:

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

How are we to interpret this?  

My take is that DSHEA is a public health disaster.  It allows supplement companies to use pretty much whatever ingredients they want and to continue doing so until there is substantial evidence for harm.

This must be an attempt by the FDA to exercise some kind of control over ingredients in supplements.  As such, the measure deserves support.

File comments by December 4; go to http://www.regulations.gov and type FDA-2017-N-4625 in the search box.

The Government Accountability Office (GAO) has a new report out calling for better federal oversight of memory supplements.

These are a growing market with sales estimated at $643 million in 2015, almost double since 2006.

FDA and FTC share oversight of memory supplement labeling and advertising, respectively, but neither approves claims in advance.  For this, thank the Dietary Supplement Health and Education Act of 1994 which pretty much lets supplement makers claim whatever they like for their products, as long as they word the claims carefully.

GAO found ads for memory supplements claiming that they would boost, enhance, improve, increase, or maintain a healthy memory.  They also made claims related to general brain health, cognitive function, and well-being.

Amazon sells these things. It advertises them like this:

Brain and Memory Booster – All Natural Formula- Brain supplement helps improve memory, mood, clarity and focus and protect against mental decline, depression, anxiety.

Do they work?

Alas, no, according to Consumer Reports.  But that doesn’t stop Americans from spending $91 million on them in 2015.

Really, something needs to be done about DSHEA.

Here’s the GAO report: Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness.
GAO-17-416.

• Report: http://www.gao.gov/products/GAO-17-416
• Highlights: http://www.gao.gov/assets/690/684621.pdf
• Podcast: http://www.gao.gov/multimedia/podcasts/684501

I am indebted to Food Chemical News (FCN) for this insight into the current lobbying efforts of the Council for Responsible Nutrition, the supplement industry’s relentless, never give up, trade group.

FCN says the Council is on track to visit all new congressional representatives with these asks:

• Allow SNAP benefits to be used for dietary supplements.
• Allow the supplement industry to self-regulate.
• Join the bipartisan Dietary Supplement Caucus.

Sigh.

Never mind that dietary supplements are hardly ever shown to improve health in healthy people, and not for lack of trying (see previous posts, below).

Never mind that this is an issue the USDA has been dealing with for years.

This industry sees the current political scene as favorable to supplements and is not going to miss this opportunity.

Oh well.

As you can see, I take a dim view of the value of supplements (yes, I know you love taking them, and how we all wish the science showed they did some good).

Here are some of my previous posts on supplements, if you want to catch up.

• Buyers beware: supplements are not what they seem. Again.
• Alas, the bad news on dietary supplements continues
• The dismal news about supplements. Why bother?
• Dietary supplements: A round-up of bad news

Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial.  Thomas M Longland, Sara Y Oikawa, Cameron J Mitchell, Michaela C Devries, and Stuart M Phillips.  Am J Clin Nutr  March 2016  vol. 103 no. 3 738-746. doi: 10.3945/​ajcn.115.119339

• Conclusion: Our results showed that, during a marked energy deficit, consumption of a diet containing 2.4 g protein · kg⁻¹ · d⁻¹ was more effective than consumption of a diet containing 1.2 g protein · kg⁻¹ · d⁻¹ in promoting increases in LBM [lean body mass] and losses of fat mass when combined with a high volume of resistance and anaerobic exercise.
• Conflicts of interest: SMP has received research funding, travel allowances, and honoraria from the US National Dairy Council and Dairy Farmers of Canada. None of the other authors reported a conflict of interest related to the study.
• Comment: Dairy, of course, is a source of protein.

Consumption of dairy foods and diabetes incidence: a dose-response meta-analysis of observational studies. Gijsbers L, Ding EL, Malik VS, de Goede J, Geleijnse JM, Soedamah-Muthu SS. Am J Clin Nutr. 2016 Feb 24. pii: ajcn123216. [Epub ahead of print]

• Conclusion: This dose-response meta-analysis of observational studies suggests a possible role for dairy foods, particularly yogurt, in the prevention of T2D. Results should be considered in the context of the observed heterogeneity.
• Funding: This meta-analysis project on dairy products and incident diabetes was funded by Wageningen University.  SSS-M previously received funding from Global Dairy Platform, Dairy Research Institute, and Dairy Australia for projects related to dairy effects on lipoproteins and mortality; JMG previously received funding from the Global Dairy Platform and Dutch Dairy Association for projects related to dairy and cardiovascular diseases; and ELD previously consulted for the Dairy Research Institute. LG, VSM, and JdG reported no conflicts of interest related to the study. Any prior sponsors had no role in the design and conduct of the study, data collection and analysis, interpretation of the data, decision to publish, or preparation of this manuscript. The current funder had no role in design and conduct of the study, data collection and analysis, interpretation of the data, or decision to publish.
• Comment: The conclusions put a positive spin on results that can also be considered equivocal.

Plenary Lecture 2: Milk and dairy produce and CVD: new perspectives on dairy and cardiovascular health. Julie A. Lovegrove* and Ditte A. Hobbs.  Proceedings of the Nutrition Society, Page 1 of 12 doi:10.1017/S002966511600001X.

• Conclusion: These apparent benefits of milk and dairy foods have been attributed to their unique nutritional composition, and suggest that the elimination of milk and dairy may not be the optimum strategy for CVD risk reduction.
• Conflicts of Interest: The authors have previously received funding for research from AHDB Dairy. J. A. L. has acted as an advisor to the Dairy Council. J. A. L. has received funding for research from Volac for BBSRC case studentship and ‘in kind’ foods from Arla for an MRC funded study.

Multivitamin/mineral supplements: rationale and safety – A systematic review. Hans K. Biesalski, Jana Tinz.  Nutrition, in press 2016.  doi:10.1016/j.nut.2016.02.013

• Conclusion: Taken together, these findings indicate that MVM can be safe for long-term use (more than 10 years).
• Funding: Editorial support was provided by Peloton Advantage and funded by Pfizer.

The challenges of vitamin and mineral supplementation in children with inherited metabolic disorders: a prospective trial.  A. Daly, S. Evans, S. Chahal, I. Surplice, S. Vijay, S. Santra and A. MacDonald.  J Human Nutrition and Dietetics.  Article first published online: 18 JAN 2016. DOI: 10.1111/jhn.12354 (thanks to Cole Adams for sending).

• Conclusions: Despite improvements in some nutritional markers, overall use of the vitamin and mineral supplement was less than prescribed. New methods are needed to guarantee delivery of micronutrients in children at risk of deficiencies as a result of an essential manipulation of diet in inborn disorders of metabolism.
• Funding: Anita MacDonald has received research funding from Merck Serono, Vitaflo Ltd and Nutricia. She is on Advisory Boards for Arla, Merck Serono and Nutricia. Anne Daly and Sharon Evans have received research funding from Vitaflo Ltd, and Nutricia. Research funding was obtained from Vitaflo International for the funding of this project.

Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine.  The athletes said that the chemical must have come from their workout supplements.  Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans.  They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA).   The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

Cohen et al. then did their own tests of the kinds of supplements the FDA had tested.  

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

The New York Times explains the context:

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

This brings us to the politics.

The supplement industry, of course, is doing everything it can to oppose and stop Schneiderman’s work.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry.  The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

The result was an increase in sales despite remarkably little evidence for efficacy.

As for conflicts of interest at FDA:

• Daniel Fabricant, the head of the FDA’s dietary supplement division at the time this was happening, came to the agency from the Natural Products Association, “Over 75 years of serving the natural products industry.” He has since left the FDA and now heads the NPA.
• The NPA spent nearly $1.5 million on lobbying in 2013 and 2014.
• The current head of the FDA’s dietary supplement division, Cara Welch, also came to FDA from the NPA.

Since DSHEA, the dietary supplement industry has gotten a pass.  Suggestions:

• Congress should rescind DSHEA and give the FDA the authority to regulate supplements as it does food.
• The FDA should appoint officials who are independent of the industries they are supposed to regulate.

I still quaintly read the paper copy of the New York Times so I know that the left column of yesterday’s  front page—judged by the editors as the second most important story of the day—was devoted to yet another exposé of supplement fraud.

The New York State attorney general did some sophisticated testing.  His report concludes that major supplement retailers—GNC, Target, Walgreens and Walmart—are selling herbal supplements that do not contain what the labels say they contain or contain unlabeled ingredients that could be allergenic.

The examples are either amusing or shocking, depending on point of view:

• A popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality”…contained only powdered garlic and rice.
• At Walmart…ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat — despite a claim on the label that the product was wheat- and gluten-free.
• Three out of six herbal products at Target — ginkgo biloba, St. John’s wort and valerian root, a sleep aid — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots.
• And at GNC…it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.

I’ve been writing about this kind of thing for years, but two aspects of this story are news.

• First, the state is doing what the FDA ought to be doing if its hands weren’t tied by DSHEA, the Dietary Supplement Health and Education Act of 1994.  That act essentially deregulated dietary supplements.
• Second, these are not some fly-by-night supplement sellers.  They are major retailers.  The supplement industry’s argument that only a few unscrupulous small supplement makers are cheating on ingredients doesn’t work in this case.

Why don’t people stop taking supplements when they hear things like this?

The major proven benefits of supplements are their placebo effects.  The actual ingredients make no difference.

The obvious conclusion is that if you must buy supplements, buy the cheapest ones.  But that doesn’t work either because more expensive supplements produce stronger placebo effects.

Placebo effects are great things, and I’m for them.  But caveat emptor.

Related documents

• The 2013 New York Times article that led to all this
• The attorney general’s cease-and-desist letters
• What’s in those supplements?
• Letters Outlining What Was Found in Herbal Supplements