Mayway, the FDA, Product Claims and Social Media
Mayway has asked me to explain to its loyal and much valued customers the reasons why they are sometimes required to not allow particular social media posts to appear on certain social media, like Facebook, or to not acknowledge or respond to some posts on other social media, such as Instagram. Mayway values its customers’ participation on social media and understands that it can be confusing and even annoying when posts do not appear or are not acknowledged.
FDA Regulations
Chinese herbs are regulated by the US Food and Drug Administration as dietary supplements. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements and their ingredients cannot be marketed with the intention to diagnose, mitigate, treat, cure, or prevent diseases. Doing so constitutes disease claims. Disease claims made by the marketers of dietary supplements are the number one category of violation types that result in FDA action, from warning letters to punitive consequences.
According to FDA rules, Mayway may not make a claim about one of its herbal products if that claim relates to a disease or medical condition. This is true whether the claim is reasonable and supported by clinical experience and literature or if it is dangerous, outlandish, or even ridiculous, as some internet claims tend to be. If a disease claim is made, then the FDA considers the product a drug and not a dietary supplement, and the requirements of drug claims are very stringent, including research, testing, clinical trials to support the efficacy and safety of the product, and importantly, the approval of the FDA.
Social Media
By way of general overview, it is useful to understand that the FDA governs Mayway’s participation on social media as it does all forms of marketing.Everything that Mayway says about its products on social media, and every way in which it reacts to what others may say is subject to scrutiny by the FDA and must be compliant with the FDA's strict herbal supplements rules.According to recent statistics, disease claims made by dietary supplement companies on social media platforms, such as Facebook, are the number one source of Warning Letters issued by the FDA, surpassing product names, websites, and other marketing materials.
It is also useful to understand that the FDA does not control what customers or commentators say about the benefits of herbal supplements on social media, so long as those statements, if not compliant with FDA rules, are not made by those connected with the company selling them or requested or encouraged or acknowledged by them. Thus, Mayway's marketing must remain independent of the comments made in a posting on social media. What licensed practitioners say to their patients when treating them, is not subject to FDA scrutiny or rules, although comments on their own social media in connection with their marketing of herbal supplements is something that practitioners should discuss with their own attorney.
And finally, it is useful to recognize that there are many selling dietary supplements online that choose to ignore the rules for their own marketing and for their interacting with customer social media comments. While the FDA has intensified their enforcement actions, it remains a fact that it is common for companies to be ignorant of the rules or blatantly choosing to ignore them.All of that creates the false narrative that it must be OK or that would not happen.
While customers who are not themselves marketing herbal supplements, may if they choose, share on social media, their experience of what they believe are the disease curing properties of a herbal supplement, Mayway cannot itself do that, or affirm, acknowledge, encourage, or voluntarily allow when a customer chooses to do that. Mayway cannot give a thumbs up, like, love or re-tweet, thereby acknowledging the claims of others, and if it does, it risks being cited by the FDA for using social media to make disease curing claims.
If you would like to research examples of FDA action on medical or disease claims for dietary supplements, here is a useful link: FDA Warning Letters
Structure and Function Claims
If Mayway cannot make claims about their products in relation to disease or medical conditions, what kind of claim does the FDA allow? The FDA does allow claims that it regards as structure/function claims, which also must be supported by appropriate evidence. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of humans or characterize the documented mechanism(s) of action by which a nutrient or dietary ingredient acts to maintain such structure or function. Structure/function claims may also describe the effect of the dietary supplement on general well-being.
So, it may be OK to claim:
That a product promotes restful sleep, but not treats insomnia.
That a product supports digestive health, but not treats indigestion.
That a product supports healthy lung function, but not treats cough/asthma.
That a product supports a healthy heart, but does not treat high blood pressure.
In summary and by way of example, Mayway would never say a product relieves arthritis pain, but it may say that a product supports healthy joints. Whether believed to be accurate or not, the first claim is a disease curing claim and not allowed in the marketing of dietary supplements.The later claim speaks to structure/function and is allowed if there is appropriate evidence to support the claim.
Mayway's Policy
Customers and commentators who are 100% independent are protected by free speech and may say what their experience is, and not run afoul of the FDA, so long as they are not encouraged to make such claims by Mayway. However, if what a customer or commentator says is in the category of a disease claim, Mayway must delete it from social media sites like Facebook, where Mayway has the ability to delete comments.Further, where Mayway does not have the ability to delete comments, it is not allowed to acknowledge such comments, for example on Instagram, or on an independent site that the customer/commentator posts on. On the other hand, Mayway may like, love, re-tweet, and be publicly grateful for comments which are couched in the language of a structure/function claim, similar to: it was good for my joint health. What customers and commentators write is up to them. Word of caution: Disease curing claims and structure/function claims may overlap, in which case the claim must be regarded as forbidden.From time to time a customer or commentator may believe what they are saying speaks to structure/function, but in an abundance of caution, Mayway will treat it as a disease curing claim.
Mayway believes that Traditional Chinese Medicine claims are appropriate, so long as the claim does not overlap with Western disease curing claims, for example, stops bleeding.
This blog post is not offered as legal advice and is intended to be purely educational. It is written to help our family of customers gain a better understanding of the FDA's requirements regarding the marketing of supplements, and limits on a company's interaction with social media comments. The examples of claims are only to delineate the distinctions between disease curing and structure/function claims and bear no relationship to any actual Mayway products. Mayway wants you to understand why it may be silent on social media when a valued customer or commentator lauds its products. Mayway remains committed to offering quality Traditional Chinese Medicine, marketed fairly, and in compliance with the laws and rules as it understands them.
*Peter Stanwyck is Mayway's long time attorney and advisor, and has worked with Mayway for more than 25 years on many issues, including FDA marketing compliance. http://www.stanwycklaw.com/