What's not to like on Facebook? FDA's View

Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19^th warning letter to mention Facebook.  Some of these letters from the past three years have also cited Twitter and Tumblr as sources of violative claims.  While these letters were primarily directed at dietary supplement companies, food, cosmetic and even drug companies can easily run afoul of FDA regulations on social media sites.

The most recent warning letter to mention Facebook, which was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own Facebook postings but notes that “Zarbees “liked” the following comment...” and goes on to quote from customer posts noting how well the products worked for coughs, insomnia and other ailments.   In 2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA gave to one of its customer’s posts about using their dietary supplement product for cancer.

The concept that testimonials presented on company websites and in other marketing materials are claims that are subject to regulatory scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa  noting that they, like all marketing claims must be truthful, not misleading and supported by data.  FDA expands requirements for endorsements and testimonials to require that they comply with regulations on allowable claims.

All companies like positive comments and testimonials from customers.  While consumer comments are not a new phenomenon, the consumer’s ability to publish their comments to the world on social media sites is new.  So what is a company to do when a happy customer posts something that makes a claim that violates the regulations governing the compliant marking of their product?  

Several of the Facebook warning letters included this note from FDA,

“We advise you review all the information on your websites, including testimonials, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.”

The last sentence makes it clear: Companies must closely monitor their social media for compliance with FDA regulations. If a post about a product goes beyond what is allowed by regulation, the posts must be deleted or edited to become compliant.

·        If you are a dietary supplement company and a customer posts that your product cured an ailment or relieved pain; your product just became an unapproved new drug subject to FDA enforcement.

·        If you are a cosmetic company and a happy customer states that your oil healed their skin condition, that oil just became an unapproved new drug subject to FDA enforcement.

·        If you are selling an OTC drug and a customer posts about a use that is not covered in the approved labeling of your product, you are also subject to FDA enforcement action.

My colleagues and I can help you stay out of trouble by reviewing or monitoring your website and social media posts, as well as your product labels and brochures for FDA compliance.  Contact us with your questions.

It is my hope that you will find these occasional updates interesting. If so, you may use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

All the best to you!

Evelyn & Associates

www.FDALabels.com 

www.BioTransApp.com

Recent FDA Guidance on Beverages, Liquid Supplements & Their Ingredients

In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla) and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26).  I will discuss the guidances in detail below but will start with the parts that are particularly interesting:

First, in addition to outlining the attributes that FDA will consider when determining whether a product is classified as a beverage or a liquid dietary supplement, the guidance on distinguishing beverages and dietary supplements also provides some interesting comments on the types of claims that may be used on beverage labels. The guidance notes that in addition to authorized health and nutrient content claims, certain structure function claims may also be made about conventional beverages.  However, FDA reminds the reader that structure function claims on foods and beverages are only permissible when the claimed effect derives from “the product’s character as a food—its taste, aroma or nutritive value.” The document goes on to state that if the structure function claim promotes the product for another use that may involve a physiological effect, then the product may be considered a drug.  This is not a new provision.  Past conversations I have had with current and former FDA staff members indicated that “nutritive value” refers to conventional nutrients such as carbohydrates, fat, protein, fiber, vitamins and minerals. This makes me wonder whether this guidance indicates that FDA objects to claims about gut health and digestive regularity as seen on some yogurt and fermented beverage products.  

FDA issued a draft guidance on liquid supplements in December of 2009.  The 2014 final guidance issued this week is not significantly different from the 2009 draft but does provide some additional detail and clarifying examples.  So how are liquid supplements and beverages differentiated?  The new guidance lists the following criteria to consider when determining the classification of a liquid product for ingestion:

1.    Product labeling and advertising.  If the product is promoted to “refresh” or “rehydrate”, then it is a beverage even if its label includes a supplement facts box.

2.      Product names.  If the product name includes terms such as “beverage”, “drink”, “water” or “soda”, the product is a beverage, not a dietary supplement.  FDA notes that the term “tea” is not used exclusively for beverages; implying that some teas may be dietary supplements but the other criteria must also be considered.

3.      Product packaging size, shape, color, design, whether it is recloseable and the volume it holds is a factor to be considered in classifying a product as a beverage or liquid supplement.

4.      Serving size and recommended intake.  The guidance states that Americans consume about 1.2 liters of water and other beverages daily.  If the serving size of a liquid product makes up a significant portion of 1.2 liters, then the product would be considered a beverage and not a liquid dietary supplement.

5.      Recommendations and directions for use. If a product is recommended to quench thirst, it would be a beverage.  If the directions were similar to ‘take one tablespoon three times per day, it is probably a dietary supplement.

6.      Marketing practices. Advertising that compare the product to other beverages or suggest that it can substitute for a beverage or if metatags are used that bring the product up in searches for beverages, then the product is a beverage and not a dietary supplement.

7.      Composition.  FDA noted that simply adding a dietary ingredient that is only permitted in dietary supplement products to a conventional food does not transform that food into a dietary supplement.  The agency gives the example that adding ginkgo to a conventional beverage does not cause that product to be classified as a dietary supplement.

8.      Other information including information found in patents or filings with the Security and Exchange Commission.

The guidance also states that powders and premixes can be either for beverage or dietary supplement purposes.  It is also important to note that the guidance discusses the fact that food ingredients must be either GRAS (generally recognized as safe) or approved food additives. GRAS ingredients and approved food additives may typically be used in dietary supplements.  However, the caveat is added that these GRAS ingredients and approved additives must be used in accordance with the regulations that stipulate the approved amounts and uses, a condition which is frequently ignored. 

The discussion of GRAS ingredients, approved food additives and dietary ingredients echoes the second guidance document that FDA published on January 13, 2014.  FDA’s purpose in issuing this guidance is “to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages.” The guidance states in part,

“We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation prescribing conditions of safe use. In addition, some substances that have been present in the food supply for many years are now being added to conventional foods at levels in excess of their traditional use levels or in new types of conventional foods. This trend raises questions as to whether these higher levels and other new conditions of use are safe.”

My interpretation of this is that FDA is eyeing the growing use of caffeine in a variety of products.  The regulation on the use of caffeine (21 CFR 182.1180) states,

(a) Product. caffeine.

(b) Tolerance. 0.02 percent.

(c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice.

Clearly there are many products caffeine-containing products on store shelves today are not cola beverages and many contain much more than 0.02% caffeine. 

Similarly there are regulations regarding the fortification of foods and beverages with vitamins (21 CFR 104.20).  This guidance may well serve to remind manufacturers of vitamin-containing drinks and other functional foods and beverages of the restrictions on adding vitamins to those products.

This guidance also notes that binders, excipients and fillers used in dietary supplements must conform to the approved uses for additives or be used in accordance with their GRAS intended uses. 

While FDA states in both of these guidances that they “do not establish legally enforceable responsibilities” I read both guidances as a heads up to industry to review the regulations covering the ingredients used in their products and also to review the classification of any liquid products offered for sale.

It is my hope that you will find these occasional updates helpful. If so, you may use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

All the best to you!

Evelyn & Associates

www.FDALabels.com  

www.BioTransApp.com

FDA Warning Letters to Cosmetic Companies

FDA Warning Letters to Cosmetic Companies

The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics.  Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning letters; however, in the past few months FDA has sent warning letters to two cosmetic companies.

In a June letter to Set-N-Me-Free Aloe Vera Company  FDA objected to therapeutic claims on the cosmetic products.  Cosmetics may be marketed to cleanse, beautify, promote attractiveness and alter appearance but not to affect the structure or function of the skin.  While in this warning letter FDA objected to some outrageous claims about cancer, it also included the following claim, which is a lot like many seen in the market today:

“Natural B-vitamins in the safflower and avocado oils [ingredients in this product] help in cell formation and build skin-immune functions. These oils renew skin flexibility by permeating natural vitamins A and E into skin cells, making regeneration of these cells occur faster.”

The claims about immune function and regeneration are problematic, going well beyond cleansing, beautifying, promoting attractiveness and altering appearance.

Last week FDA published a letter sent to Vienna Beauty Products.This was the most disturbing warning letter I have ever read about a cosmetic company. According to the letter Vienna Beauty Products were producing cosmetics under insanitary conditions that included:

“Apparent filth and dust build up on manufacturing equipment in the production area” 

“A layer of sediment and encrusted material was observed on the exterior and tops of production kettles.”

“The last cleaning [of the production room floor] was performed November 2010.”

“The 250 and 500 gallon kettles were last cleaned 15 years ago.” 

“The last cleaning of the 400 gallon shower gel kettle could not be determined.” 

“Additionally, the finished product storage tank and storage totes were said to have last been cleaned over 20 years ago.” 

Not surprisingly, these conditions led to production of products with high bacterial counts.  The scary thing is that Vienna Beauty Products manufactures several private label lines of product for major retailers.

Since registration of cosmetic manufacturing facilities is voluntary, I wondered how the FDA ever discovered all the problems at Vienna Beauty Products.  I noticed that the warning letter was signed by Paul Tietell, District Director of FDA’s Cincinnati District Office.  Mr. Tietell used to be in the Denver District Office and I had the pleasure of serving with him on the board of the Rocky Mountain Regulatory Affairs Society, so I wrote to ask him how cosmetic companies come to FDA’s attention.  Here’s his reply,

“Cosmetic establishments may find their way to FDA's OEI (Official Establishment Inventory) in a variety of ways.  

In addition to the firm registering with FDA through the VCRP, the firm may also be a manufacturer required to register under one of many existing regulations.

The firm may have been involved in a complaint (Consumer, Med-Watch other agency referral) and have been entered into our OEI in conjunction with our receiving and recording of that complaint.

The firm may have come to the attention of a FDA through general surveillance of retail sales, by observation during and employee's day to day operations, or perhaps through observation of an advertisement.”

This means that if you advertise or sell cosmetics, you could be subject to FDA inspection.  It also means that you should review your manufacturing methods against FDA's Inspection Checklist  and be sure to have your labels reviewed for regulatory compliance.

Cosmetic companies provide products to help make the world beautiful and attractive.  The folks at FDALabels.com and Bioscience Translation & Application would like to help you keep your business beautiful.  Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

We hope you find these occasional posts interesting and informative.  You can subscribe to our mailing list by replying to this post.

The Cosmetic Team

FDALabels.com

Bioscience Translation & Application

Labels as Tables of Contents

Greetings!

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (http://www.nosco.com/), presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, www.BioTransApp.com or www.FDAlabels.com for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.


Copyright 2011 Bioscience Translation & Application

Does your Contract Manufacturer Comply with cGMPS?

Hello!

I hope that your business is doing well enough to allow you to relax a bit as summer starts.  Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs are up to snuff?  Many of you will recall conversations we’ve had about ingredient specifications and certificates of analysis. Well, today I saw a well-written article on this topic in Natural Products Insider by Kevin Cloud, senior method development chemist in the Capsugel Licaps® laboratory.  You may read the article below or link to it here: http://www.naturalproductsinsider.com/articles/2011/06/inquire-about-incoming-ingredient-inspection.aspx

FDA continues to inspect dietary supplement manufacturers and to write warning letters detailing a wide variety of GMP violations. Responding to such letters and correcting the violations can mean that your manufacturer may not be able to fulfill your next order on time or worse, that your product will have to be recalled and possibly destroyed if not produced under cGMPs.  Something like that would certainly ruin your summer.

Avoid future problems by thoroughly investigating your manufacturer and suppliers and be aware of the GMPs that you as the distributor must have in place.  The team at Bioscience Translation & Application wants to help you succeed.  Contact us for help with labels, GMPs or your questions about FDA regulations and processes.

Happy Summer!

Evelyn & Associates

Bioscience Translation & Application

Inquire About Incoming Ingredient Inspection

By Kevin Cloud

Natural Products Insider

June 17, 2011

 Dietary supplement cGMPs (current good manufacturing practices) establish minimum practices necessary for activities related to manufacturing, packaging, labeling and holding dietary supplements to ensure product quality. The final product owner is ultimately responsible for the dietary supplement that is released to the market, and each company in the supply chain contracted by the final product owner is responsible for ensuring its activities comply with cGMPs. Final product owners should make sure contract manufacturers have the resources, processes and commitment to comply with the cGMPs.

One important part of the equation for manufacturers is to ensure the integrity and quality of the raw materials purchased for production of finished goods. Federal regulations require manufacturers establish raw material specifications covering identity, purity, strength, composition and limits on contamination before placing an order.

How can the final product owner ensure these specifications are met? By asking three simple questions related to ingredient identification, and getting the answers related to testing, equipment and results in writing.

Question 1: Can I see the raw material specifications for raw material X that will be included in my product?

The contract manufacturer should provide a copy of a specification with all of the testing that is expected to be performed plus the criteria for passing or failing the raw material. Following are examples of mandatory specification parameters and what information they provide:

• Identity: What is the substance? Is it the ingredient as desired, to ensure the integrity of the product as labeled? Or is it a mixture or even perhaps an entirely different substance altogether?
• Assay: Determines the strength or potency of a substance.

Contamination: Determines unwanted substances in the raw material, such as heavy metals, pesticides and residual solvents, and any allowable limits.

Question 2: What instruments does your facility use to identify the incoming raw material X and can I see the qualification package for at least one of these instruments?

The manufacturer should have the ability to provide copies of the qualifications for each instrument listed. A qualification is made up of three distinct parts: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The qualification package is usually purchased at the time the instrument is installed or moved. The qualification is performed by a certified technician from the manufacturer of the equipment.

Typical laboratory instruments used for testing include high performance liquid chromatography (HPLC); gas chromatography (GC); ultraviolet visible spectroscopy (UV/Vis); fourier transform infrared spectroscopy (FTIR); high performance thin layer chromatography (HPTLC); melting point (MP); microscope; and near infrared spectroscopy (NearIR).

Question 3: What types of methods are you using to assay incoming raw material X and can I see a validation/verification summary and standard operating procedure (SOP) for that raw material?

From the list of instruments above, HPLC is the workhorse of the nutrition industry for analyzing potency or strength of a substance. But HPLC is only a piece of equipment. A method, or set of directions, is also essential to assay a sample; it is like a road map for the HPLC.

Whatever method or direction is used—and there are many from a wide variety of sources—it should be scientifically valid. Some recognized scientific compilations of methods are the U.S. Pharmacopeia (USP), American Oil Chemist Society (AOCS), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP). Methods are often put into a company’s particular format, such as a SOP, a standard operating instruction (SOI) or a work instruction (WI).

Remember the final product owner is ultimately responsible for the dietary supplement released to the market, and that responsibility includes ensuring the product is manufactured, packaged, labeled and held according to dietary supplement cGMPs. Asking some basic questions related to ingredient qualification can provide helpful information, realizing a manufacturer that is missing any of the three major components—raw material specs, qualified instruments or written procedures—is not compliant with cGMPs.

Evelyn Cadman

Principal Consultant

Hand Sanitizers and OTC Drug Regulation

In August of last year we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that has been “tentative” since 1994. This week FDA issued four warning letters to companies promoting hand sanitizers and other products as effective again MRSA (methicillin-resistant Staphylococcus aureus bacteria).  FDA issued a press announcement about these letters due to the concern that the public could be misled and subsequently harmed by the MRSA claims (http://tinyurl.com/4x6j777).  I find the warning letters interesting because of what we can learn about the regulation of over the counter drug products, particularly those under review by FDA or subject to tentative final monographs.

One of these warning letters went to Oh So Clean, Inc, doing business as CleanWell Company, which markets thymol-based hand sanitizers and sanitizing wipes. (Thymol is a constituent in the herb thyme.)  The warning letter demonstrates how FDA can enforce the stipulations of over the counter drug monographs that remain tentative. The warning letter results from FDA inspection of the company in August of 2010.  At that time CleanWell Company received a 483 letter detailing the violations FDA observed during the inspection. The warning letter issued last week notes that the company’s September response to the 483 letter “lacks sufficient corrective actions” and details FDA’s findings that the products are unapproved new drugs.

Based on the product labels and the company’s website, FDA categorizes the CleanWell products as “OTC topical antimicrobials” and cites the tentative final monographs (TFMs) for OTC healthcare antiseptics and OTC first aid antiseptics as the governing regulations for these products.  Interestingly, the response to an inquiry our company made to FDA in 2009 listed only the healthcare TFM as pertaining to hand sanitizers. Nevertheless, both of these monographs are being evaluated under FDA's OTC Drug Review process and the April 18 warning letter notes that “Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the TFM.”  Unfortunately, the CleanWell “products’ formulation and labeling are not consistent with any of these TFMs.”  You can review the TFMs at http://tinyurl.com/3pxx464.

So what were the problems with these products?

First, the drug facts boxes identified Thymus vulgaris oil (thymol 0.05%) as the only active ingredient. The pertinent TFMs do not list this as an approved active ingredient but the First Aid Antiseptic TFM lists thymol in combination with eucalyptus, menthol, methyl salicylate and alcohol as an acceptable active ingredient. In addition, the product claims go beyond what is permitted by the tentative final monographs for antiseptic products. In particular, the claims of effectiveness against MRSA are non-monograph. The only way to make claims outside of those detailed in the monographs is to undertake clinical trials in order to gain FDA approval for new over the counter drug claims.

Even if thymol alone were an acceptable active ingredient for this type of OTC product, the company’s own website and other labeling state that active ingredient used in the products is a blend of essential plant oils.  FDA refers to incorrect labeling such as this as “misbranding”.

The warning letter further cites violations of good manufacturing practices, which render the products “adulterated” and orders the company to “cease manufacturing and distributing all your unapproved new drug products” and to take corrective action and respond to the warning letter within 15 working days. This is undoubtedly a real blow to products that were available in several well-known retail outlets.  

Similar problems were noted in the other warning letters about MRSA claims—simple failure to follow the monographs, which detail how to formulate and label over the counter drug products.  It is our view that timely and competent review of the product labels and claims could have helped these companies identify the issues cited by FDA and remain active in the marketplace.  Is your product compliant with applicable FDA regulations or has a slight tweak of the marketing materials skewed your claims beyond those permitted?  Let the Bioscience Translation & Application team help you ensure compliance so your marketing plans are not disrupted by FDA enforcement activities.

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Johnson & Johnson Consent Decree: A lesson in Drug cGMPs

The folks at Pharmalot have written an article about the Johnson & Johnson consent decree (http://tinyurl.com/4bxxl44).  The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. 

The consent decree details the systems that need to be set up to ensure that the company's drug products are produced properly and are safe and efficacious. The document makes clear that the plant needs to build a quality system from the ground up and is evidence of the catastrophic QA failure that lead to the recalls and the consent decree itself.  

My purpose in posting this information is not to spread salacious gossip but to provide what I think is useful information.  In my view, the consent decree can be used as a checklist to review the cGMPs at your manufacturing facility.  If you are unable to download the consent decree, please leave a comment with your email address and I will send it to you. (Your email address will not be published.)

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