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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The FDA also announced that it is accepting public comments on its draft guidance.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• Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry
• Federal Register Notice for the Draft Guidance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• 2011 (July):  FDA publishes draft guidance
• 2017 (September):  FDA issues draft guidance for comment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

Ebola is much in the news, and for good reason.  It is highly contagious, difficult to contain, and deadly.

In food studies, we say that food is a lens through which to view the most important problems of society.  Here are some thoughts on the food politics of Ebola.

Dietary Supplements for Ebola Prevention or Treatment

The Council for Responsible Nutrition, the trade association for supplement manufacturers, has found it necessary to issue an advisory on use of dietary supplements to prevent or treat Ebola infections.

The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) are therefore endorsing the following unified advisory for marketers and retailers, as well as for consumers of dietary supplements:

• Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing Ebola virus disease, or preventing Ebola virus infection.
• Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for Ebola virus disease.
• Anyone who believes they may have Ebola virus disease or may have come in contact with the Ebola virus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on Ebola virus disease and the proper actions to take if you suspect you are ill.

The knowledge that no known treatment exists for Ebola has not stopped supplement manufacturers from advertising the benefits of their products for this infection.

FDA Warning Letters

The FDA has stepped in and issued warning letters to three manufacturers marketing their products as possible treatments or cures.  The FDA letters, which make interesting reading, went to:

• Natural Solutions Foundation
•  Young Living
• dōTERRA International LLC

Marketing of Nutritional Supplements

A simple Google search of “supplements Ebola” turned up this kind of information this morning:

The Ebola virus can be destroyed naturally – despite what you’ve been told To date, not a single virus has been tested that is not inactivated (killed) by a large enough dose of vitamin C (ascorbic acid). Many other antioxidants have similar virucidal effects, but vitamin C appears uniquely to be of greatest potency and clinical efficacy, as its simple chemical structure allows for it to be disseminated throughout the body with little restriction… Vitamin C is both very potent and optimally bioavailable in accessing any viral infection.

And this:

The substances in the Natural Allopathic protocol for Ebola offer a power unequalled in the world of medicine that we can harness to save many lives of people infected with Ebola…. Magnesium salts, sodium bicarbonate (baking soda), iodine, selenium and vitamin C are concentrated nutritional medicinals that have been used in the direst of medical circumstances…The core of the Natural Allopathic protocol redefines the way emergency room and intensive care should be practiced on Ebola patients with proven fast-acting, safe, concentrated and mostly injectable nutritional medicines. If the Ebola infection truly gets out of hand, it is comforting for parents to know that they can legally administer these same medicinals if infected people are treated at home. All of the Natural Allopathic Medicines can be also taken orally or used transdermally (topically) to almost the same effect if treatment is started early enough.

How Can Supplement Makers Do This?

The ability of supplement manufacturers to claim health benefits for their products, and mostly get away with it, is a result of congressional action in passing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated these products.

Twenty years later, the supplement industry is deeply divided between responsible and irresponsible manufacturers, both allowed by law.

As the president and CEO of one supplement company puts it,

The industry of 1994, roughly $8 billion in sales, has experienced compounded double-digit growth every year since DSHEA became law…DSHEA opened the door to growth, innovation, new science, new discovery and a nation of wanting consumers enchanted with the thought that there are natural solutions to their individual health needs…20 years later, it’s time to take a hard look at what DSHEA doesn’t provide to the industry today. The barrier to entry into this industry continues to have no hurdles; DSHEA does not define the boundaries of consumer trust… The generations of today, and the generations of tomorrow will demand transparency, they will demand efficacy, and they will demand quality and safety from all of us.

Clearly, they aren’t getting that now.

Other Connections to Food Politics

Chocolate

Politico writes:

EBOLA THREATENS WORLD’S CHOCOLATE SUPPLY:  Ivory Coast, the world’s largest producer of cacao, the raw ingredient in M&Ms, Butterfingers and Snickers Bars, has shut down its borders with Liberia and Guinea, putting a major crimp on the workforce needed to pick the beans that end up in chocolate bars and other treats just as the harvest season begins… the outbreak already could raise prices…Prices on cocoa futures jumped from their normal trading range of $2,000 to $2,700 per ton, to as high as $3,400 in September over concerns about the spread of Ebola to Côte D’Ivoire.

Food safety

Food safety lawyer Bill Marler points out that Ebola started out as a foodborne illness.    Its most likely source was infected bushmeat that transferred the virus to human handlers.

Following standard food safety procedures is always a good idea while hoping that health officials get this epidemic under control.

Section 7606 of the 2014 Farm Bill says that notwithstanding the Controlled Substances Act, The Safe and Drug-Free Schools and Communities Act, and other laws that govern the cultivation of marijuana, it is now OK for state agriculture departments and universities to grow “industrial” hemp for research purposes.

Industrial hemp, the Farm Bill says, means “the plant Cannabis sativa L…with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.”

To put this in context: the average THC potency of domestically grown recreational hemp  (a.k.a. marijuana) is about 6 percent, but can go much higher.

With so little THC in industrial hemp, why would anyone want to bother with it?   Textiles of course, but also medical purposes and dietary supplements.

Even a little THC, apparently, goes a long way.

The New York Times reports that companies are growing industrial hemp to make hemp oil as a treatment for epilepsy.

On the legalities of hemp oil, The Times explains that the

Drug Enforcement Administration is offering few clues, insisting in public statements that while it is willing to allow marijuana sales in states that have legalized the drug, it might step in if growers try to sell beyond state borders…Any chemical that comes from the plant is still a controlled substance…When we get into hemp, it gets a little squishy, but it still is illegal.

Squishy?  Growing and using industrial or recreational hemp is illegal in America except in states that have made hemp legal or quasi-legal.

For example, New York State recently passed a hemp bill that would set up pilot programs for the production of industrial hemp.

At least one company is growing hemp in Colorado for use in dietary supplements.   At a trade show last year, it displayed US Hemp Oil promoted for its content of CBD—cannabidiol, a non-narcotic fraction of the hemp plant.

The company insists that CBD is a legal ingredient of dietary supplements.

Hemp, it argues, is a vegetable:

The pure oil is considered GRAS [generally recognized as safe]. Under the United States Uniform Tariff Code they tax and code hemp as a vegetable. I don’t know anything that’s a vegetable that isn’t GRAS. When we import it, it is always considered a vegetable, so that’s what we use in our declaratory actions…in March of last year Canadian company Abattis announced plans to bring a CBD-infused kombucha drink to market.

However and whether CBD works for medical purposes, everyone expects industrial hemp to be a huge cash crop for its textile and health food uses.

This is especially a boon for Kentucky, and it’s no coincidence that Kentucky Republican Senator Mitch McConnell spearheaded the hemp provision through the Farm Bill.

The boon-for-Kentucky Website provides a long list of potential applications for industrial hemp, ranging from textiles to cosmetics to auto parts.

Proponents of CBD provide an even longer list of diseases for which industrial hemp’s CBD is a treatment option.  There isn’t much research on the physiological effects of CBD.  This makes industrial hemp perfect as a dietary supplements.  It might do something.  That’s all you need for supplement marketing.

The legal battles will be fun to watch.  Stay tuned.

In the meantime, there is hemp cereal—organic of course.  Enjoy!