Feeling Regulatory Pressure, Amazon Puts Supplements in the Hot Seat

The phrase, “hot on Amazon” is taking on new and problematic meanings for the dietary supplement industry this Spring.

Beginning on April 15, Amazon began requiring supplement companies that sell on the platform to guarantee that their products can withstand temperatures up to 155o F, and still meet label claims for stability and potency.

Companies that cannot guarantee heat stability will risk having their temperature-sensitive products dropped from Amazon.

The online retail titan has acknowledged that, while it is not the norm, products it handles may sometimes reach these temperatures while in storage warehouses or during transport.  Not surprisingly, this is more likely during the summer.

Having a Meltdown

For that reason, Amazon issued a memo to all sellers stating that meltable inventory will not be fulfilled or accepted by Amazon fulfillment centers as of May 1. Meltable products will be accepted again starting in October.

Amazon explicitly defines “Meltables” as “heat-sensitive grocery, health, and personal care products that are eaten or swallowed, including chocolate, gummies, and probiotics.” Companies selling such meltable products on Amazon were given the option to submit “removal orders,” to have the products taken off the sales platform and returned—for a fee.

After May 1, meltable products not reclaimed with a removal order will be “disposed of,” and companies risk losing the all-important Amazon Standard Identification Numbers (ASINs) for the products in question.   

Simply put, Amazon does not want to deal with dissatisfied customers unhappy with melted or spoiled purchases. So, the company is asking manufacturers to either guarantee their products will not degrade at high temperatures or take them off the virtual sales shelves during the summer months.

An Amazon trailer travels near Orland, CA. Amazon now requires supplement brands to guarantee heat stability of their products, because temperatures inside warehouses and on trucks can sometimes exceed 155 degrees in the summer months.

That’s a worrisome prospect for supplement makers because many supplement ingredients and formulations will break down and lose potency if exposed to temperatures in the temperature range that Amazon has specified. Most probiotics, fish oils, and many botanical extracts are heat labile, and susceptible to degradation at high temperatures.

Any ingredient delivered via softgels or gummies will not likely withstand high temperatures, even if the active ingredients themselves are intrinsically heat stable.

Some products will melt outright if stored in an overheated warehouse or transported on a non-refrigerated delivery truck, leaving the end user with a bottle full of partially liquefied goo.

Amazon has had a longstanding year-round prohibition against the sale of products requiring refrigeration, air conditioning, or freezing. Likewise, the platform refuses to handle perishables including fresh meats, fruits, or vegetables.

But a lot of consumable products—including many types of supplements—fall into a grey area. They’re not “perishable” in the sense that raw fish or fresh fruits would be. But they are meltable or otherwise prone to damage at high heat.

Amazon currently has no standard operating procedures (SOPs) for the temperature control of the warehouses or trucks used to store and transport supplements. According to supplement industry representatives who are in dialog with Amazon on this issue, the company has no imminent plan to change the situation.

Amazon’s new rule about meltables is not specific to supplements; it applies to all categories of products sold on the platform. And Amazon’s executives may not have realized the vast number of supplements and other health products that could potentially disappear from its online retail logs because they are potentially meltable.

Revenue at Risk

Amazon sales are a major portion of business for many supplement makers, accounting for anywhere from 40% to 60% of total annual sales. If they cannot sell all their potentially meltable and heat-sensitive products on Amazon for half the calendar year, they stand to lose significant revenue.

The reality is that many Americans rely on Amazon for purchasing supplements, along with most other routine household products. The elimination of potentially meltable products will adversely impact consumer access, at least during the warm weather months.

Amazon’s inability to handle temperature-sensitive consumer products is no secret. It is one of several issues for which the company has been widely criticized in recent years.

Amazon’s improper handling of temperature-sensitive products is one of a number of issues for which the company has been criticized in recent years.

Supplement industry insiders say action to rectify this problem has been a long time coming. But they argue that by putting all the burden of product integrity on manufacturers, Amazon is shirking its own responsibility to step up its storage and shipping game.

Industry consultant Michael D. Levin argues that because Amazon stores and transports food and supplement products, the company should be required to comply with all Good Manufacturing Practices (GMPs) pertaining to the handling of these products. This includes temperature control guidelines.

Temperatures in the 155o to 175o F range are well beyond the acceptable range stipulated by the FDA’s GMPs for supplements. Any manufacturer that knowingly or unknowingly permits its products to be exposed to such heat levels would clearly be in violation of GMPs, and subject to reprimand by the FDA.

“Materials Management 101”

Most well-established supplement makers have invested heavily in temperature control in their manufacturing and storage facilities, as well as in their transport operations.

They do extensive testing—including perpetual storage of batch samples– to ensure that the products are stable and able to meet label claims when they leave the factories. And they ensure that the products are appropriately shipped so they’re intact and stable when they arrive at the distributors and the retail outlets.

Levin and others believe Amazon ought to do the same.

“This is materials management 101,” he told Holistic Primary Care. It’s something that licensed drug wholesalers figured out long ago.

He believes it is entirely reasonable to think that a company as sophisticated as Amazon, which handles OTC pharmaceutical products and has a generic prescription pharmaceutical business (Prime Rx) could find and implement methods for storing and transporting heat-sensitive supplements and other consumable health products.

Given the high economic stakes, some companies may be tempted to lie about the heat stability of their products, and hope that in the majority of cases the products make it to their purchasers without any degradation.

Though tempting, it is a foolish strategy. Companies that do so will risk their reputations as well as their ASINs if there are summertime product meltdowns.  Further, by guaranteeing heat stability on products that will likely degrade at high temperatures, the companies are assuming full responsibility for customer dissatisfaction.

Putting it bluntly, Amazon has made it clear that it will not take on the responsibility for potentially meltable products at this time.

“This is an issue of great concern to all of us,” says Loren Israelsen, President of the United Natural Products Alliance (UNPA), who has been in frequent conversation with Amazon representatives over the last few months. “Amazon gets that. The current policy is for the brand holder to determine if their products meet the temperature range requirements.  I anticipate this policy will be amended in due course, given the need for both brand holder and all those that handle, store, or ship dietary supplements to manage temperature and other environmental conditions.”

Amazon’s warehouses are not necessarily temperature-controlled. Many supplement ingredients including fish oils and probiotics, as well as anything in gummy or softgel form, are subject to degredation at high temperatures.

Fundamental Shift

Amazon’s new heat stability requirement follows on the heels of the company’s wider initiative to clean up its act with regard to supplements, nutritional products, and foods.

Federal regulators have put the online giant in the hot seat for, among other things, abetting the sale of counterfeit, adulterated, or fraudulent supplements, and for permitting sellers to make misleading or unsubstantiated disease treatment claims, especially for products marketed as COVID-19 treatments.

Under looming threats of litigation, congressional oversight, and reputational damage, Amazon signed an agreement with the Department of Homeland Security to address COVID-related fraud claims. Last November, the company announced a plan to implement a new Dietary Supplements Compliance Program (DSCP) to stop unlawful product claims and eliminate unsafe, adulterated, or poor-quality products.

The DSCP represents a fundamental shift in Amazon’s approach to dietary supplements, and indicates a more active role in policing the products offered on its platform.  In recent months, the company hired roughly 80 full-time employees to implement and enforce these new standards.

Thorough Documentation

The compliance program obliges supplement sellers to provide Amazon with a Certificate of Analysis (CoA) for each product, to demonstrate that the products are manufactured in compliance with nutrition labeling requirements as outlined in Title 21, section 36 of the Code of Federal Regulations (CFR 101.36), with current Good Manufacturing Practices as listed in 21 CFR Part 111, and with risk-based preventive controls as detailed in 21 CFR 117.

These CoAs must be issued from an ISO/IEC 17025 accredited analytical laboratory (external or in-house, if the in-house lab is part of a GMP-certified manufacturing facility), or from a lab that can demonstrate full compliance with GMPs as defined by 21 CFR 111 and 117.

The certificates must be up to date, based on analysis done within the 12 months prior to submission, and must contain full details on ingredients, and batch/lot number or date code of the finished product sample tested. They also need to include the name and address of the accredited laboratory, results from the relevant assays to support the dietary ingredient concentration as claimed on supplement facts panel, and clear documentation of the lab method(s) used.

Supplement companies must also ensure Amazon that their products only contain ingredients designated as lawful and safe, as defined in section 402 (f) of the Food, Drug, and Cosmetic Act.

Amazon will also permit products enrolled in the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, UL Brand Certification Program.

Supplement industry leaders are generally supportive of Amazon’s intention to eliminate fraudulent products and bogus claims. The rampant sale of cheap, poor quality supplements based on miracle promises is bad for consumers and damaging to the field as a whole.

Based on his dialog with them, Israelsen says Amazon’s dietary supplement compliance team is resolute about cleaning up the playing field for online supplement sales, and to improve customer confidence and satisfaction by eliminating poor quality, substandard, or damaged products.

“They’re really working on this, and it is in our clear interest to support them.” He says Amazon is listening to industry representatives, and revising and strengthening company policy when appropriate and where feasible.

The current version of the DSCP guidelines is, he says, a vast improvement over earlier iterations.

“Their compliance focus is on engaging existing industry resources by adding new 3rd party GMP certifiers, allowing in-house lab C of A’s of GMP -compliant manufacturers, and implementing tighter and more specific data points on C of A’s.  In a word they are saying , ‘Show us, don’t just tell us you are compliant.”

But many of the issues, such as the handling of meltables, are logistically complex. Solutions will require significant operational changes across multiple departments within Amazon’s massive and deeply siloed kingdom.

“Temperature management is an industry wide challenge, not just an Amazon challenge,” notes Israelsen. “This will be an all-hands-on-deck issue as global temperatures are rising and supply chains are getting longer. “

Double Standards

For the foreseeable future, supplement makers–and their customers–must deal with Amazon on Amazon’s own terms.

The situation has definitely created rancor among supplement company executives. Some resent the fact that Amazon is subjecting supplement companies to increasingly high standards of testing and quality assurance, while exempting itself from compliance with even the basic GMPs for product storage and shipping.

Amazon’s position is that it is a tech company in the business of using technology to facilitate and fulfill online commerce; it is not itself a manufacturer of products and therefore it is not subject to GMPs.

Given Amazon’s size and its market dominance, it is unlikely that any single industry would have the leverage to force Amazon to change. That, insiders say, would require a concerted action from the Food and Drug Administration.

While it is within the realm of possibility that the FDA might someday force Amazon to comply with GMPs and implement procedures for ensuring the integrity of meltable health products, it is not likely to happen any time soon.

FDA does not currently have a commissioner, many of its top officials have stepped down, and a major proportion of its human resources is engaged in efforts to contain the pandemic. Pushing Amazon to do a better job of handling fish oils and probiotics is probably not a policy priority in Washington, DC, these days.

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