Tag Archives: FDA



In the last post we learned that FDA enforcement against supplement and nutraceutical makers based on their social media activity is no longer a hazy nightmare.  It has emerged into our recent reality.  What can supplement or natural products makers do to protect themselves from an FDA enforcement action while maintaining a presence in social media?   Below are some suggestions that apply to social media interactions as well as to more traditional sales and marketing activity. As always, please consult a regulatory attorney for more comprehensive advice, or contact the FDA for more information that relates to your specific product.

1. Develop a Social Media Policy

Your company lawyer (if you have one) may not see the many casual interactions on the company’s social media pages. However, your social media managers will, so it is important that they understand the boundaries of engagement with fans and how to handle and respond to fan comments. Include a reporting process for any potentially problematic interactions. While social media has memory, the employees who use it on behalf of your business should be trained on what to post, what to report internally, and what to delete. Even if your company does not use social media, your staff should be fully trained on how to respond to customer feedback and the appropriate use of testimonials.

2. Avoid Even the Appearance of Reliance on Risky Testimonials

The consuming public, and especially those who use social media, look for the opinions of others before deciding to buy. As such, testimonials present a double-edged sword. On the one hand, they make marketing easier, but in the marketing of regulated products FDA views them as “long-arm” extensions of product promotion. Therefore, testimonials should be carefully managed. A testimonial can’t be repeated if it makes statements on behalf of the company that your staff could not directly say without breaking promotional rules. General endorsements, such as “I love this product!” may not cause an FDA inquiry, but an endorsement that says “This product cured my impotence” is probably unwise.

3. Labeling, Labeling, Labeling.

On or off social media, the first and most basic step any company can take is to vet its labeling for compliance with FDA regulations. Your labeling includes the container, the carton and any inserts or standalone literature that you distribute which has information about the product. It also includes your web sites and any information you post on social media information pages. Therefore, all these should be reviewed to ensure there are no assertions about your product (referred to as claims) that cross the line into the “forbidden garden” of drug promotion. Avoid claims that state the product treats, cures, mitigates or prevents disease. That is sometimes harder to do than it may seem for a natural products company. What if you want to talk about the benefits of a well known natural product, like garlic? There may be rules or exceptions that apply to specific ingredients and to the ways in which you plan to use them. You may therefore want to consult a regulatory lawyer to get help in formulating your labeling strategy.

4. Be Clear About FDA Approval Status

Simply put, don’t claim that your product is “FDA Approved” if it isn’t. It doesn’t matter if your product contains an ingredient that has been approved under an FDA monograph, or is Generally Recognized As Safe for the same use for which it’s included in your product. If the public could read your product label and think that you received approval from the FDA to market the product that is actually in the container when in fact you haven’t, you probably won’t get away with it.

5. Don’t Overreach

Saying I can practice medicine because I watch medical dramas on television, no matter how many I’ve watched over the years, wouldn’t get me hired as a physician because I can’t show any proof of my skill as a doctor! By the same token, overselling your product by claiming it has attributes you can’t prove will attract problematic attention from regulators. In many cases, companies that received warning letters were also engaged in other behaviors that FDA probably considered too egregious to ignore. The agency’s job is to protect the public, especially vulnerable populations, from products that make promises they have not been clinically shown to satisfy. With this in mind, take a look at your product line. If your lineup includes products with claims that unabashedly recite drug-like action, such as “fights infections,” “cures diabetes” or “inhibits tumor growth,” please immediately consider a full labeling review. The overall posture of your company and product lines might make a big difference in whether or not you become a target for immediate enforcement action.

6. Be Prepared To Support Your Claims With Good Data

If you’ve taken the time to develop clinical studies and lab test results, you may be able to back up specific claims about your product, but that data by itself won’t exempt your company from the requirement that all products claiming to be “drugs” must first be approved. But maybe your product will fall into one of FDA’s many monograph categories, or it might be appropriate to initiate some dialogue with the agency to determine whether you have enough data to secure formal approval. You should absolutely vet your claims with a regulatory attorney or the FDA before you proceed.

7. Pay attention to your manufacturing and quality control

This is not so much a social media issue, but it does present an area in which we have seen an increase in regulatory activity.

Deanna Baxam is an attorney at Baxam Law Group, LLC.

This post is provided for information purposes only. It is not intended as a substitute for consultation with a qualified attorney.  Copyright 2014, Baxam Law Group, LLC. All rights reserved, please repost with attribution.
Baxam Law Group, LLC
Law For Today’s Business ®
Find us on the web at: www.baxamlaw.com
Facebook: Baxam Law Group
Twitter: @innovationlawyr


The “Like” With A Bite – FDA Warning Letter Puts Supplement Makers On High Alert

Companies have come to recognize social media as an important communication venue for   engaherbalcapsulesging consumers, who are spending more and more time online. In the more informal world of social media, product makers and retailers work hard at being interactive and approachable. It is generally accepted that exchanging dialogue with a company’s fans or audience on social media pages leads to a more positive overall perception of the company and its products.

The primary desired result of social media engagement is to build relationships that encourage brand loyalty. In building such relationships, using the language and communication style of the audience is one of those intangible yet incredibly important factors that contribute to social media success. Businesses looking to use social media keep these motivations top of mind. In practical application, companies will often hire social media managers to monitor their accounts on platforms such as Facebook® and Twitter®. The kinds of engagement that build relationships with an audience include “liking,” commenting on or re-posting (i.e. republishing) fan posts. On more traditional web sites, companies have included testimonials about services or products on blogs and product information pages.

Against this backdrop, the US Food and Drug Administration recently issued a warning letter to a Utah-based herbal supplement maker. The warning stated that the company, Zarbee’s, Inc., made promotional claims through social media interactions and postings which suggested their natural products were intended for use as drugs. The FDA’s definition of the term “drugs” includes any substance which is intended for treatment, cure, mitigation or prevention of disease, the disease in this case being coughs and colds.

According to the warning letter, the company endorsed or promoted personal testimonials from Facebook users on its page. As examples, the letter listed “Likes” and comments made by the company in response to page visitors:

  • “Liked” the comment: “…[product name] …I received the free sample…and…gave it to my daughter…I could not believe how well it worked! She was recently diagnosed with ADHD and put on medication…causing insomnia…”
  •  “Liked” the comment: “Love Zarbee’s this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days.”
  • “Liked” the comment: “Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…”
  • Commented, “Thank you for writing this!!! We love to hear that we have helped people…”
  • Commented, “… [W]e switched that item out with our [product name] which works great!!!”

FDA also noted posts the company had made on its own, and stated these posts provided additional evidence that the products were intended for use as drugs:

  • [Product name] extract…helps thin and loosen wet mucus coughs….
  • “Dark honey [an ingredient used in [product name] and [product name]… is clinically proven to calm coughs and sore throats in children…”.

It is not new in the world of regulatory law and science that statements which suggest a product acts like a drug will be reviewed as drug claims, and that such statements could call into question the approval status of the product as a drug. However, FDA’s observation that “liking” a third party’s comment on social media equates to an endorsement or promotion has not so far been a frequent occurrence. This letter highlights the risks for food, drug and cosmetics (and maybe even medical device) makers who use social media.  Most social media managers have used the Like button without giving much thought to government regulations. Under these circumstances, a random Like could cost the company a lot, yet not having a social media presence is also undesirable.

Once the FDA determines that a company has made claims that a product is intended for use as a drug or that it acts like a drug, the company is exposed to a threat of prosecution for selling an unapproved drug. Also, if the labeling for the product does not conform to the Food, Drug and Cosmetic Act and the regulations, it could be deemed misbranded. FDA alleged that the Zarbee’s social media statements risked violations for being unapproved drugs and for misbranding. 

[A warning letter is a notice that requires a response and further action. Unless the threat to public health and safety is immediate and significant, a warning letter is usually the first action that FDA takes, and if sufficient remedial actions are taken other enforcement may be averted.]

What can supplement or natural products makers do to protect themselves from an enforcement action?   I’ll discuss that in Part II of this two-part blog post.

Deanna Baxam is an attorney at Baxam Law Group, LLC. This post is provided for information purposes only. It is not intended as a substitute for consultation with a qualified attorney.
Copyright 2014, Baxam Law Group, LLC. All rights reserved, you are free to re-post with attribution.
Baxam Law Group, LLC
Law For Today’s Business ®
Find us on the web at: http://www.baxamlaw.com
Facebook: Baxam Law Group
Twitter: @innovationlawyr

Whistleblower Claims – Corporate Land Mines

From that delicate balance between preserving the public good and the right of private action has emerged that most persuasive, and potent, moderator – the whistleblower claim.  In our laws, the purpose of whistleblower provisions has been to enable employees, representatives and even business partners to report behavior that has harmed or could potentially cause harm to the interests of the government or the public it serves.  The underlying rationale is that reporting this behavior removes the potential harm,  punishes the offenders and makes an example of their behavior as a deterrent against future bad acts, therefore “blowing the whistle” should be encouraged and the person or persons who do it should be rewarded.  Over the years, several well-recognized statutory programs based on federal law have included whistleblower provisions. These include the Occupational Health and Safety Act, the Internal Revenue Service Code and the Fair Labor Standards Act.  State laws are also armed to respond to whistleblower complaints.

For example, a $327 million judgment against drugmaker, Johnson & Johnson, under the South Carolina Unfair Trade Practices Act was just reported to have been upheld.  A whistleblower claim triggered this case, which has so far led to lawsuits by multiple states alleging that their Medicare and Medicaid programs have been defrauded.  The South Carolina  fine was calculated by assessing $4,000 for every “Dear Doctor” letter the company sent to physicians claiming that the drug was better than the competition and $300 for every sample it gave away to healthcare professionals.

But it’s not just big pharmaceutical companies that have been caught in the dragnet of a whistleblower complaint.  In the healthcare arena, the threat is very real for distributors of durable medical equipment and for physicians, physician assistants and nurse practitioners who participate in treating patients and reporting the services provided.  Outside of healthcare, recent whistleblower claims were filed by Alcohol, Tobacco and Firearms (ATF) agents (click link for story), to report violations of the Occupational Health and Safety Act, the Internal Revenue Service Code and the Fair Labor Standards Act.

Here are some useful tips for handling whistleblower scenarios.  For employers:

  • Develop and communicate a procedure for reporting potential compliance violations that is confidential, responsive and can be accessed by employees outside the regular chain of command. Maintain confidentiality as much as possible, and inform the employee of the outcome of your investigation.
  • Carefully address any complaints raised by employees that involve potential violations of federal or state law, and document the resolution.
  • Often, companies do not know the identity of the whistleblower until the indictment as been unsealed.  Even if you receive this information, do not take any personnel action against an employee or business partner because they filed a whistleblower complaint.

For employees:

  • If possible, discuss your concerns with your managers, or if you feel uncomfortable about doing so, with your company’s compliance officer.
  • Continue to observe the rules and requirements of which you are aware while the investigation is progressing, and to do your job.
  • You may choose not to raise the issue internally and report it directly to the government, usually with the assistance of a qui tam lawyer. Supporting facts are very important to substantiate a whistleblower complaint, so be prepared to present information that would adequately support your case in court.

Federal and state whistleblower cases may request civil and/or criminal penalties and often disqualify companies or persons found guilty from participating in government fee-for-service or procurement programs.  The fines are usually high and are a significant source of revenue for cash-strapped government agencies as well.   The number of these cases, especially in the healthcare field, has been increasing and the trend is expected to continue.

Additional links: http://www.whistleblowers.gov/, http://bit.ly/sxFL6V , http://www.irs.gov/compliance/article/0,,id=180171,00.html,

Baxam Law Group, LLC advises clients on business, intellectual property and healthcare law matters. Visit us on FacebookFollow us on Twitter.

New Guidance for Dietary Supplement Manufacturers

 The FDA today released new guidance for sellers of dietary supplements.  The guidance addresses how to determine whether an ingredient should be considered a New Dietary Ingredient (NDI), and the requirements for filing a pre-market NDI notification.  

FDA said another motivation for providing the guidance is to improve the quality and quantity of NDI notifications.  There are an estimated 55,600 dietary supplement products on the market, but FDA has only received about 700 NDI notifications since it began reviewing them 16 years ago.  Approximately 1,000 new dietary supplements are introduced to the market each year.   The low number of NDI notifications, plus FDA’s concern that some dietary supplements contain undeclared active ingredients, has prompted more attention on using these filings as a preventive monitoring tool. 

The agency is inviting response from the dietary supplements industry on today’s guidance.

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA).  

Baxam Law Group advises clients on complying with the regulatory requirements for marketing of consumer products.

Related articles

Banaba and Diabetes

While traveling outside the US recently, a kindly woman encouraged me to investigate a natural product she said was a “miracle worker” for people managing diabetes as a chronic condition.  I forgot all about it for a while, but recently I was reading a supplement label and noticed that name again — Banaba extract.  Also known by a host of other names, such as Corosolic acid, Queen’s Crape Myrtle, Pride-of-India, and perhaps more formally as Lagerstroemia speciosa, this extract is being touted by many diabetes sufferers as a good naturopathic option.  According to other online sources, Banaba extract may also be helpful in weight loss.

Read more from WebMD about Banaba extract.

If you make or sell natural therapies, contact us learn more about how to label and market your products in compliance with federal rules and guidelines.

Photo from Dave’s Garden.

Baxam Law Group, LLC;  www.baxamlaw.com

FDA Forum On Clinical Trial Design For Small Companies

Of the 18 new drug and biologics molecules approved in 2010, about half seemed to have been developed by small companies. The Center for Drug Evaluation and Research (CDER) just announced an upcoming forum on designing clinical trials.  This session is specifically for small businesses who want to learn more about how to plan and execute trials so they will generate data that meets FDA‘s review standards.

The meeting will be held on April 21, 2011 from 9:00 a.m. to 4:45 p.m. at the FDA White Oak Campus in Silver Spring, MD, just outside Washington, D.C.

According to CDER, topics to be covered include:

– Clinical trial design – the phased approach and the staged approach

– FDA’s Bioresearch Monitoring (BIMO) Inspection Program

– Challenges to conducting clinical research in the 21st century

– Practical concerns of electronic source documentation

– Different types of pharmacokinetic studies conducted during drug development

– Importance of bioequivalence studies

– Strategic Quality for Clinical Trials

– FDA inspection process

There is no fee to register for this meeting, and there are limited seats available.

Register, and download the agenda and presentation slides here.

Baxam Law Group, LLC advises startups and small business clients in intellectual property, regulatory and commercial law.

Pfizer Takes Supplements

Pfizer®, that pharmaceutical behemoth of the late 20th century, announced today it is buying the consumer products business of Ferrosan, a Danish supplement maker.  The deal price was not disclosed, but according to Yahoo Finance, Ferrosan said its 2010 earnings were about $55 million.  That is small pickings for a company of Pfizer’s size, but it is yet another trickle in the shifting tides of big pharma’s business focus.  

Truly novel blockbuster drugs are few these days.  One could speculate ad nauseum on the reasons for this, but one possible cause is that the companies who invest money in bringing drugs to market don’t want to risk big money on unproven chemical entities and metabolic pathways that might also be a challenge to cautious regulatory reviewers like those at the FDA.  The results of this very conservative approach from the industry (and from the government)are drugs that for the most part improve upon or modify some known molecular structure or sequence that has shown some success in the past.  It is good business investment for the drug companies, but not so much for the consumers who need “disease preventers” instead of palliative treatments, and for those who are already sick and need a new therapeutic approach instead of a variation of the tried and true.

There is a new wave coming, and in my opinion big cures will be coming from natural products and botanicals in the early part of this century, so this is a good move on Pfizer’s part.  It’s good for consumers too, because big drug companies have the cash to do the studies that would support approval of natural products and botanical therapies, even by the most conservative of regulatory systems.  Let’s hope we see more moves like this. 

Read Pfizer’s press release

Other new product prototypes to watch include Dendreon’s Provenge® immunotherapy treatment for advanced prostate cancer.

Senate to Vote on Food Safety Bill Tonight

The Senate will vote on  S. 510, its final version of the FDA Food Safety and Modernization Act, in an evening vote beginning at 6:30 PM EST tonight.  The  House passed its version with a large margin of supporters some time ago, so it seems safe to presume some form of  expanded federal legislation on food safety is well on the way to becoming final.    The bill’s sponsor in the Senate is Richard Durbin (R – IL), who leads a bipartisan roster of 20 co-sponsors.

Open Congress summarized some provisions of the bill, but tonight’s vote includes a couple of potentially significant amendments that aren’t that closely linked to the issue of food safety.  Take for example the two competing amendments from Republicans and Democrats that would repeal the 1099 reporting requirement previously passed in the healthcare reform bill, which has all small business owners issuing IRS-1099 forms to any vendor paid $600 more in the tax year.   The original reason for this reporting requirement was probably to help the IRS track taxable income to vendors and service providers, but it could greatly increase the reporting burden and expenses for small businesses.    The food bill also includes an amendment introduced by Senator Tom Coburn (R-OK), which formalizes the self-imposed Republican ban on earmarks. 

Provisions of the Food Safety Bill will allow:

  • FDA to order a recall if a food facility does not initiate a voluntary recall
  • New standards for produce safety during production and harvesting
  • Fees (or fines, depending on your perspective) for recalls or government reinspection of facilities
  • Regulation of sanitary food transport
  • Development of new school guidelines for managing food allergens
  • Implementation of a National Agricultural and Food Defense Strategy

Local Food Exemption:  An earlier Senate compromise exempts farmers who make less than $500,000 per year and sell directly to consumers, restaurants and groceries within a 275-mile radius of their farms from some of the bill’s requirements, such as the development of  comprehensive food safety hazard analyis and critical controls (HACCP) plan.

Subscribe to our mailing list.

NIH Solicits Collaborative Research Proposals for Rare Diseases; Orphan Drug Workshop Update

On Tuesday, November 2, the National Institutes of Health Center for Translational Research announced its first solicitation for collaborative research projects by NIH’s new Therapeutics for Rare and Neglected Diseases (TRND) program.  Entities interested in partnering with NIH to develop clinical candidates in this category must submit initial applications by December 6, 2010.

About two weeks ago, the FDA and NIH also co-sponsored their first workshop on Accelerating Therapies for Rare Diseases, which was aimed at supporting industry efforts to develop orphan drugs.  (Even though there is no official categorization of “orphan devices,” the process applies to these as well.)  I attended this innovative partnership meeting, which included detailed presentations and discussions with agency officials about IND requirements, clinical trial design, endpoints and standards, and use of biomarkers and surrogates for orphan drugs; as well as how applications will be evaluated, and how to communicate with FDA.

 The meeting also included a presentation on the venture community’s perspective on funding orphan drug development.  Currently, there is also a federal Orphan Grants Program which provides some limited support to researchers involved in orphan drug development, up to $200,000 per year for Phase 1 and up to $400,000 per year in phases 2 and 3.

 Accelerated orphan drug (and device) approval is available for previously marketed therapies with a newly determined orphan indication, or for an orphan drug which may also have potential therapeutic benefit in non-orphan indications. An orphan drug designation is not required for orphan drug grant funding, but there should be enough data to support the research hypothesis.

The application for collaborative research projects may be found here: http://bit.ly/8WWLiU

 Information on the Orphan Drug Grants Program is here: http://bit.ly/lTAu7

 Current grant-funded orphan drug and device research is listed here: tp://bit.ly/byrWvL

 For questions about the regulatory process in this area or related intellectual property issues, please feel free to contact me.


Deanna L. Baxam

Baxam Law Group, LLC

Law For Today’s Business SM

2180 Satellite Boulevard, Suite 400

Duluth, GA 30097

O: 678 462 0041

M: 678 896 1986

F: 888 425 7365


Facebook: Baxam Law Group

Twitter: innovationlawyr

Blog: https://innovationlawyr.wordpress.com


Forest Laboratories Signs on the Dotted Line… with Feds

More than 6 years of pre-penalty discussions between Forest Laboratories (“Forest”) and the U.S. Attorney’s Office for the District of Massachusetts culminated September 15  in an agreement that settles criminal and civil investigations by the government into the company’s activities.  Forest agreed to plead guilty to a single felony charge of misrepresentations to FDA inspectors during a 2003 plant visit, and two misdemeanor violations of the Food, Drug and Cosmetic Act.  The first misdemeanor charge was for distributing Levothroid® after the FDA told the company an NDA would have to be filed for the drug; and the second related to off-label promotion of Celexa® for treating pediatric patients.  The fines for these charges cost Forest $150 million, and the company also forfeited another $14 million in revenues.

On the civil side, Forest also settled claims under the False Claims Act and several whistleblower (qui tam) claims relating to distribution of Levothroid® and several years of off-label promotion of Celexa® and Lexapro® for pediatric uses.  The off-label promotion in this case related to an earlier formulation of Lexapro®; Forest later requested and received approval to promote a later formulation for pediatric use.  The total payout under these civil claims, including to the feds and state Medicaid programs, was $149 million.

As a commitment to future good behavior, the government also required that Forest operate under a Corporate Integrity Agreement for five years.  Nowadays, these agreements not only call for a compliance program to be put in place, but the government also wants key senior managers, not just the CEO, to monitor and oversee activities within their scope of responsibility, and to certify they have done what is required every year.  These leaders include the heads of Marketing, R&D and Human Resources, to name a few.   The Board of Directors is also required to retain an independent Compliance Expert to review and report on the effectiveness of the Compliance Program annually.

Interestingly, news that this drawn-out investigation has come to a point of resolution seems to have helped the company’s stock performance today.  Forest closed up 2.02% from yesterday’s trading at a respectable $31.27 per share.  This might have been helped by the news that the fines were well within the reserves the company had set aside to cover the financial damage from the legal proceedings.

Learn more about Baxam Law Group at www.baxamlaw.com.