Currently browsing posts about: Supplements

NutraIngredients-USA.com has posted a set of articles celebrating the 25th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which effectively deregulated the supplement industry.  The articles that follow are from the perspective of that industry.

Personally, I’m not a fan of DSHEA, and view deregulation of dietary supplements as a mistake for the industry as well as for the public.  Strong regulation inspires trust.  Weak regulation encourages distrust of supplement products and the entire industry.  When I see a Supplement Facts label, I have no reason to trust that the label reflects the contents of the package.  Until supplements are subjected to the same level of regulation as food products, caveat emptor.

Special Edition: DSHEA at 25

The Dietary Supplement Health and Education Act of 1994 created the framework for the modern supplement industry. In 1994, the industry was worth $4 bn. Now it is estimated to be worth over $40 bn.

In this special edition we will talk to some of the industry legends who helped to craft the law, we’ll learn about NPQAA, we’ll hear from the head of the FDA’s Office of Dietary Supplement Programs on the need to modernize the law, get the views of some of the industry association leaders, and look to the future.

• DSHEA at 25: In conversation with Scott Bass and Loren Israelsen: The brilliant strategy of Sen. Orrin Hatch, the upswell of grassroots consumer pressure, and the ‘highly unusual’ personal intervention of an FDA Commissioner: The development and passage of the Dietary Supplement Health and Education Act is a fascinating story….. Read
• What was NPQAA and what role did it play in the successful passage of DSHEA?  While much of the focus around DSHEA was on Capitol Hill and the machinations of government, an important behind-the-scenes contribution came from the short lived Natural Products Quality Assurance Alliance. But what was NPQAA and how did it help?.. Watch now
• FDA’s Tave: ‘Opportunity to strengthen regulatory framework couldn’t come at a more pivotal time’: With scientific advances and the growth of the dietary supplements industry on one hand, and the proliferation of adulterated and misbranded products on the other, the opportunity to modernize DSHEA couldn’t come at a better time… Read
• DSHEA Was Not Carved in Stone: Want to spark controversy? Just suggest to some audiences that it’s time to amend DSHEA… Read
• Balancing consumer access and safety: Looking back 25 years, there are several remarkable aspects of the Dietary Supplement Health and Education Act (DSHEA) amendments to the Food Drug and Cosmetic Act (FD&C Act), which transformed how dietary supplements are regulated… Read
• Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’  As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant… Watch now
• Critic says FDA’s slow enforcement makes ‘DSHEA 2.0’ a side issue: Industry critic Dr Pieter Cohen, MD, said FDA’s enforcement is overly deliberate, making any discussion about revisions to DSHEA more or less moot… Read
• Bodybuilding.com VP on DSHEA: What changes could improve the regulation of dietary supplements: Bodybuilding.com’s John Venardos shares some of his ideas to improve the regulation of the dietary supplements industry, from better transparency to greater FDA staff accountability, and how to level the playing field… Watch now
• If botanicals don’t fit easily under supplement heading, why not try to fix that?  Should the creation of a new herbal medicine category be one of the goals of the upcoming discussions about a new regulatory framework? If it were possible, such a change could clear up many of the ambiguities surrounding the marketing of these products as dietary supplements… Read
• What should DSHEA 2.0 look like? Here are a couple of suggestions: On Monday FDA Commissioner Scott Gottlieb put forward some ideas about where the regulation of dietary supplements should go in the coming years. This is an opportunity that should not be missed. What should be tops on the industry’s wish list?.. Read

 

I thought the FDA had decided long ago that dietary supplements were untouchable, given the Courts’ interpretation of the Dietary Supplement Health and Education Act (DSHEA) of 1994.  DSHEA essentially deregulated dietary supplements and blocked the FDA from doing much about them unless it could prove substantial harm.

Whenever the FDA tried to intervene, supplement companies took the agency to court on First Amendment grounds, and won most of the time.  So the FDA appeared to have given up.

But here we have FDA Commissioner Scott Gottlieb announcing new steps to take back some oversight of this industry.

These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

The FDA issued a press release to announce 12 warning letters and 5 online advisory letters to companies illegally selling more than 58 misbranded products claimed to prevent or treat Alzheimer’s disease.  The demographic change to an aging population:

has been accompanied by a growth in the number of marketers who prey on this population, pitching products that make unproven claims that they can prevent, treat, delay, or even cure Alzheimer’s disease.  These purported miracle cures are sold primarily on the Internet. They are often, though not always, falsely labeled as dietary supplements. Regardless of their form, these products fly in the face of true science. What these companies are selling is the false hope that there is an effective treatment or cure.

Commissioner Gottlieb also sent out a chain of Twitter announcements explaining what this is about.

Cheers to the FDA for this one.  And now get busy on the rest of the bad apples in this barrel.

The Government Accountability Office has just published a report on memory supplements.

Available data indicate that memory supplements constitute a small segment of the overall dietary supplement market, but their sales nearly doubled in value from 2006 to 2015, increasing from $353 million to $643 million. Consumers searching to prevent or treat age-related memory loss, including Alzheimer’s disease, have increasingly turned to dietary supplements for help.

What did the GAO do?

This report examines the extent to which selected memory supplements contained: (1) their stated ingredients at the quantities stated on their labels and specific adulterants, and (2) certain contaminants.

Uh oh.  Never mind whether memory supplements do any good (a dubious claim).  They don’t even contain what they claim to contain:

• One product, marketed as Ginkgo biloba, did not contain that ingredient. Instead it contained an unknown substitute; as such the safety of the product is unknown.
• The second product was marketed as a supplement that included Ginkgo biloba. It also contained an unknown substitute, instead of Ginkgo biloba.
• The third product, marketed as a fish oil supplement, contained the stated ingredients.

Supplement products, you will recall, are essentially unregulated, by Congressional fiat (see the Dietary Supplement Health and Education Act of 1994).

Since none of these supplements has been shown to improve memory, what’s in them only matters if it causes safety problems.  Fortunately, the study found contaminants to be a low levels.

When it comes to dietary supplements, caveat emptor.

The food industry is intensely interested in personalized nutrition because it can create and sell products appeared to be aimed directly at individual lifestyles and preferences.

This approach is aimed much more at marketing than it is about public health.

With that said, take a look at how the food industry is using this idea.

Special Edition: Personalized Nutrition

The future is personal, but the revolution is already taking place around us. Innovative science is combining with entrepreneurial endeavor to bring personalized nutrition to our fingertips.

Personalized nutrition is breaking down the silos and bringing together experts in genetics and genomic profiling, microbiology, nutrition and diet, mobile technology, big data, healthcare and more.

In this special edition we talk to the pioneers and experts in this sector, the scientists and the emerging brands, and the tech developers bringing the personalized nutrition future to the present day.

• Personalized nutrition approaches helping to drive evolution of supplement retailing: Personalized nutrition is being folded into the ongoing evolution of retailing in the dietary supplement space, market experts say… Read
• Research backs personalized nutrition process, even if data on customized products lacks, expert says: While personalized nutrition proponents like to push the benefits of the approach, there is little research that backs the notion that products customized for individual consumers lead to better health outcomes than do more generic formulas. But that misses the point, said one expert… Read
• Persona CEO: ‘Chase the shiny new technology that has a big price tag – that’s not always the best solution’: Is a lifestyle questionnaire ‘personal’ enough for personalized nutrition? Persona’s founder and CEO Jason Brown talks about growing a business in the personalized nutrition space.. Read
• Personalized nutrition ‘milestone’: InsideTracker data validates algorithmic platform to improve wellness: Data from 1,033 generally healthy individuals using InsideTracker shows that the automated, web-based personalized nutrition platform is capable of normalizing serum biomarker levels in healthy subjects… Read
• Food selfies and data: Nutrino wants to make personalized nutrition easier for users:A mathematician and an engineer bootstrapped a nutrition-tech company about seven years ago. Their goal was to create a platform that documents the diverse ways human bodies extract nutrition from food… Read
• ‘Hyper-personalised’ recommendations: Spoon Guru targets global domination with growing list of partnerships:UK food tech start-up Spoon Guru has a goal of becoming the dominant technology platform for users looking for product recommendations based on specific lifestyle goals or dietary needs, says co-founder and CEO Markus Stripf, as the company looks to increase its partners globally and launch in the USA… Read
• Nordic Group: Nutrigenomics needs to be ‘done with integrity’ – it’s too early for direct consumer models: Nutrigenomics is gaining plenty of attention but it remains extremely complex and unadapted to direct-to-consumer models, says the MD of Nordic Group – owner of DNA Life and more recently AthGene… Read
• Lux Research: ‘It’s paramount that microbiome data is used for personalized nutrition’: A new market research report explores how the personalized nutrition space can elevate itself beyond “just recommending diets” and become an integral part of preventive health care… Read
• Weight loss presents ‘lucrative’ opportunity in nutrigenomics, says analyst: Nutrigenomics remains a growing niche within the burgeoning personalised nutrition trend but there is significant potential to spark mass market appeal with a focus on weight loss, says a consumer expert… Read

NutraIngredients is another one of those industry newsletters I read every day.  Here is its collection of articles—a special edition—on supplements.  In the United States, supplement ingredients and labels are governed by the Dietary Supplement Health and Education Act of 1994, which effectively deregulated the products leaving the public to take the products on trust, sometimes justifiably, but sometimes not.

Special Edition: Transparency in Dietary Supplements

Issues concerning adulteration, identity and others swirl around the dietary supplement industry.  In this special edition, NutraIngredients-USA looks at the opportunities for proactively dealing with these questions in an effort to boost transparency and retain consumers’ trust.

• What’s in my product? Supplement brands, suppliers get creative as they vie for consumer trust:  From profiling their ingredient suppliers to setting up codes consumers can look up, supplement brands are using transparency to win over consumer trust… Read
• Transparency lens focused on supply end of supplement industry: Securing sources of supply is not only good business practice, it can also boost a company’s transparency efforts. Examples abound of companies putting raw cost concerns aside to push forward efforts to make sure fragile ecosystems are protected and potentially endangered species are nurtured… Read
• Efforts by AHPA, BAPP pull back veil on issues relating to identity, adulteration: Efforts by two major groups in the botanical trade are boosting transparency relating to the identity and purity of these ingredients… Read
• The dietary supplement industry has morphed into something much bigger, industry expert argues: “We are no longer the dietary supplement industry,” said Scott Bass, partner and head of global life sciences at Sidley Austin LLP, during his opening remarks as co-chair of ACI’s Sixth Annual Legal, Regulatory and Compliance Forum on Dietary Supplements in New York last week… Read
• Trade group advocates to keep skip lot testing option in dietary supplements GMPs: The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice… Read
• Study highlights progress in turmeric supplement quality, but concerns around synthetic curcumin adulteration: A new analysis of 87 different turmeric dietary supplements has highlighted the diversity of available products and the challenges this gives consumers. Concerns were also raised around potential adulteration with synthetic curcumin… Read
• Boswellia oleogum resin prone to adulteration, new bulletin outlines: The botanical Boswellia has been used for its anti-inflammatory properties for millennia, but it’s not uncommon to find some products today labeled as Boswellia to skimp on the amount of the botanical or to substitute in a less-researched form… Read
• Observers question adverse event reporting compliance for products sold on Amazon: Some industry observers are starting to question how many of the thousands of supplements sold on Amazon and other high volume online platforms comply with adverse event reporting requirements and other rules pertaining to the sales of these products… Read
• Consultant launches new regulatory compliance certification for dietary supplement companies: Curtis Walcker is the consultant slash owner behind consulting firm Dietary Supplement Experts, LLC. He launched a new certification this week, designed based on client feedback, to focus on everything from GMPs to FTC compliance… Read

This comes from one of those daily food-industry newsletters I subscribe to, in this case NutraIngredients.com.  It occasionally focuses on regions and I thought this collection of articles was of interest.  Do Latin Americans need dietary supplements?  Just asking.

Welcome to NutraIngredients’ first quarterly supplement focusing on the Latin American dietary supplements and functional food markets. In this edition, we look at the changing regulatory landscapes across the region, including a deep dive into how Brazil is creating a distinct category for supplements. We’ll also look at a supplement start-up and opportunities for omega-3s in LATAM.

• More education will help realize huge potential for omega-3s in Latin America: Consumers in Latin America understand the general benefits of omega-3s. But there is a need for more education to help capture the huge potential for the ingredients in this region where the market is far from saturated… Read
• LATAM’s regulatory landscape: From Argentina to Uruguay: The regulations around dietary supplements in Latin America are a patchwork of different approaches, but regulatory bodies and regional associations are pushing for change and perhaps even some harmonization… Read
• Florida start-up CareMundi brings US supplements to Brazilian buyers: In the dietary supplement world, Brazil is notorious as being a tough market to get into. But there is demand for US-made products in the country, and one-year old start-up CareMundi, an online sales platform, is providing a bridge for US supplement makers into Latin America’s largest consumer market… Read
• Brazilian regs to be altered to finally create distinct category for supplementsNew regulations set to take effect in Brazil will significantly improve market access for dietary ingredients and finished dietary supplements, an expert says… Read  The possibility of incorporating the health benefits of probiotics into fortified fruit snacks could be a reality thanks to researchers in Brazil… Read
• Brazilian regulatory overhaul will benefit omega-3s, consultant saysThe outlook for omega-3s in Latin America is bright, according to a consultant experienced in the region. In particular, there is regulatory acceptance for these ingredients across the continent… Watch now

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.