Waiting on FDA

Hello!

I hope that 2016 is off to a good start for you and your business and that you are looking forward to great new things!  While we look forward to seeing what 2016 will bring, many industries continue to wait for action from FDA.  I have listed just a few topics that various industry sectors hope to have clarified in 2016 below.

Foods

It has been two years since FDA proposed dramatic changes to nutrition labeling regulations (http://tinyurl.com/jjvls5q) .  Will the final rule require that ‘Added Sugars’ be listed in the nutrition facts box as originally proposed?  Industry has objected to this particularly since the amount of sugar added to jams, applesauce, etc. can vary with the inherent sweetness of the fruit. Since there is no lab test that can distinguish between naturally-occurring and added sugars, it is difficult to understand how FDA, which prides itself on being a science based organization, can ensure compliance with this rule.

Restaurant Menu Labeling: The publication of the final rules for calorie declarations on restaurant menus was delayed in 2013 and then in 2015 the compliance date for this regulation was delayed by one year to December of 2016.  Will chain restaurants really be required to post caloric values on their menus and menu boards?  While seemingly simple, there are genuine challenges with complying with this rule.  First, the accuracy required by the regulation could be tough to meet since even though restaurants are careful about portioning, there is variation.  Second, the regulation requires chain restaurants to list the calories on alcoholic beverages but the wine, beer and spirits industries are not required to provide calorie information. How is a restaurant supposed to comply? (See more on the rule: http://tinyurl.com/j7vwkgo.)

Pet Foods: In 2007 Congress mandated that FDA take over regulation of pet food.  Since that time FDA has been working with State pet and animal food regulators to come up with ingredient definitions that would meet FDA criteria.  As that progresses, FDA’s Center or Veterinary Medicine is scheduled to publish draft guidance documents that pertain to the pet food industry:

Animal Food Current Good Manufacturing Practices

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Human Food By-Products for Use as Animal Food

Dietary Supplements

It has been four and a half years since the first draft of the proposed guidance on New Dietary Ingredients was published (http://tinyurl.com/jtuqe4r) .  In 2013 FDA has proposed that the final rule would be published in 2014.  We are still waiting but it could be published any day!

Over the Counter Drugs

The FDA monograph that covers hand sanitizers and antibacterial soaps and body washes has been tentative since 1994.  In 2010 a lawsuit was filed to try to force FDA to finalize the monograph.  In December of 2013, FDA published a proposed rule stating that there was not sufficient data to support the safety of these products and that additional data on both safety and clinical benefit was required (http://tinyurl.com/z26bgs4).  The comment period closed in June of 2014 but no final rule has been issued.

Homeopathics

Both the FDA and FTC held hearings in 2015 looking into the regulation of homeopathic medicines.  The tone of these hearings made it very clear that both agencies view homeopathic products as quackery and would like to change the regulatory framework for homeopathic products.  Under the current policy, homeopathic products that comply with the Homeopathic Pharmacopoeia of the United States (HPUS) may be marketed in the US.  Unfortunately, some companies have introduced products that do not comply with HPUS to the market.  It seems that this is due, at least in part, to FDA’s complete failure to enforce the current regulations that apply to homoepathics.  This industry is waiting to see whether it will have a place in the US marketplace.

Cosmetics

Will the voluntary cosmetic registration and GMP program become mandatory? For years there have been bills introduced in Congress to more tightly regulate the cosmetic industry.  Discussions on Cosmetic Safety Legislation between the FDA and the cosmetic industry broke down in 2014 (http://tinyurl.com/hkmzhg7). Will we see fundamental changes to the way cosmetics are regulated in 2016?

It can be difficult to keep up with all the possible regulatory changes that can affect your day to day operations.  My associates and I work hard to stay abreast of FDA regulations, policies and related issues so we can help you stay compliant. Contact us with your questions and we’ll do our best to keep you up to date on FDA’s activities.

Please 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.

Regards,

Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

FDA Update Purchasing Controls

Last week I attended a meeting with FDA staff from the Denver District Office.  The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society.  Since most of the members work with medical devices, the speakers from FDA focused on that industry sector and in particular talked about Purchasing Control Regulations since failure to comply with them results in a large number of failed inspections, warning letters and product recalls each year. The term “Purchasing Controls” is only used in the regulations for medical devices but the language of these regulations are informative for dietary supplement, food and cosmetic companies as well. 

The regulations covering good manufacturing practices (GMPs) for dietary supplements commonly use the phrase, “ensure that the [product, components, labels and packaging] are consistent with your purchase order”.  The GMP regulations for foods and the GMP guidance for cosmetics both refer to specifications for ingredients.  Since it is impossible to consistently make quality products unless you have ingredients of consistent quality, it is imperative that your purchasing department have detailed information about the requirements for each ingredient or component used in your product.  In other words, purchasing needs detailed ingredient/component specifications. 

Let’s take a brief look at the medical device purchasing control regulations to learn more:

21 CFR 820.50(b) states, “Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services…”

This could mean that the herbs you purchase must be accompanied by chromatograms that document the amounts of key phytochemical components.  It may mean that you must list a range for the required viscosity of certain oils to ensure that your cosmetic will have the right thickness.  In the case of a food ingredient such as cayenne pepper, it may be important to define the acceptable Scoville Heat Units so that the final product will live up to your label claims of mild, medium and hellfire.

21 CFR 820.50(b) continues, “Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.

This is a very important consideration for companies that are using contract manufacturers.  Your contract with your manufacturer should explicitly define not only which ingredients may be substituted but what substitutions are acceptable and that you are to be notified when the manufacturer finds it necessary to make any change to your product.

As specified in the device regulation, the best way to ensure that you always get quality ingredients and services is to first set requirements/specifications for your ingredients, components and service providers and then evaluate their ability to meet your requirements before you contract with them. If your company has purchasing controls that are followed and followed up on by the quality and manufacturing departments it is far more likely that the products, components, labels, etc. will be consistent with your purchase order and meet your specifications.  That in turn will please your customers!

I started my consulting business in 2001 after 15 years working in FDA-regulated industry.  Since that time my colleagues and I have served hundreds of dietary supplement, food, cosmetic and device companies from around the globe.  My colleagues and I are ready to help you determine which FDA regulations apply to your product and what you need to do to comply with them. Contact us today by replying to this message.

As always, we hope you 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

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